JOHN CARLOS I

KING OF SPAIN

To all who present it and understand it.

Sabed: That the General Courts have approved and I come to sanction the following law.

PREAMBLE

I

Biomedical and health sciences research is a key instrument to improve the quality and life expectancy of citizens and to increase their well-being, which has changed substantially, both methodological as conceptually, in recent years. The emergence of new analytical tools has led to great discoveries that allow to harbour well-founded hopes for treatment and even healing in the not too distant future of hitherto unaddressed pathologies.

In a few years it has been extremely important to obtain, use, store and transfer biological samples for diagnostic and research purposes, and the investigations that involve Invasive procedures in humans, and research with gametes, embryos or embryonic cells has become essential in the field of cell therapy and regenerative medicine. However, these scientific advances, and the procedures and tools used to achieve them, generate important ethical and legal uncertainties that must be properly regulated, with the balance and prudence required by such a subject. complex that affects the identity of the human being so directly.

In addition, these new scientific advances question the organization in which biomedical research has so far been based, which in this new context requires a multidisciplinary approach, the approach of the basic researcher to the clinical and network coordination and work, as the necessary guarantees for the procurement of quality research.

Spain, which already participates in a determined manner in the generation of biomedical knowledge, is not interested in the interest in these investigations and the debate they raise. In this sense, public administrations are decisively supporting biomedical research and are contributing to this end important economic and human resources and the necessary infrastructure to promote it. Both the General Administration of the State, in exercise of the competence of promotion and general coordination of scientific and technical research provided for in Article 149.1.15. of the Constitution, as the administrations of the communities The Commission, in its opinion on the proposal for a Council Directive on the coordination of the laws of the Member States with a view to the implementation of the Directive on the environment, health and safety at work, different research bodies and universities and the institutions themselves of the System National Health, with the aim of making efficient use of the resources available and obtaining, from the contribution of the different research groups, results that can be transferred to the improvement of the health of the citizens. In this way it is fulfilled in the field of biomedical research with the mandate set out in article 44.2 of the Spanish Constitution, which entrusts to the public authorities the promotion of science and scientific and technical research in benefit of the general interest.

This Law is part of this context and if, on the one hand, it responds to the challenges posed by biomedical research and tries to take advantage of its results for collective health and welfare, on the other, it drives and stimulates action The Commission has also been able to provide a framework for the coordination of public and private research bodies and institutions, which are equipped with the best instruments to fulfil their task. In order to achieve these objectives, moreover, the Law sets standards in areas not regulated to date or which have been fragmentary or alien to the changes in recent years, such as genetic analysis, research with human biological samples, in particular those of an embryonic nature, or biobanks.

II

In view of this, it is necessary to have the appropriate regulatory framework in place to respond to new scientific challenges while ensuring the protection of the rights of persons who may be affected by the research action.

In fact, some of the most sensitive aspects related to biomedical research, both internationally and within Spanish society, have been the subject of open and extensive debate, which has allowed for to deduce principles and criteria, of increasing acceptance, from which to build norms and rules of conduct that manage to establish the necessary balance between the needs of the researchers and the trust of the society in the scientific research. According to this spirit, this Law has as one of its priority axes to ensure the respect and protection of the fundamental rights and the public freedoms of the human being and other legal goods related to them that he has given Our legal system, in particular the Spanish Constitution and the Council of Europe Convention for the Protection of Human Rights and the Dignity of the Human Being in Respect of the Applications of Biology and Medicine, signed in Oviedo on 4 April 1997 and entered into force in Spain on 1 January 2000. Consequently, the Law proclaims that the health, interest and well-being of the human being who participates in a biomedical research will prevail above the interest of society or science.

In particular, the Law is built on the principles of the integrity of persons and the protection of the dignity and identity of the human being in any biomedical research involving interventions on human beings, as well as in the conduct of genetic analysis, the processing of genetic data of a personal nature and of biological samples of human origin that are used in research. In this sense, the Law establishes that the free autonomy of the person is the foundation from which the specific rights are derived to grant consent and obtain prior information. It also establishes the right not to be discriminated against, the duty of confidentiality on the part of any person who in the exercise of his or her functions access to personal information, the principle of gratuitousness of donations of material (i) biological, and sets standards of quality and safety, which include the traceability of human tissues and cells and the strict observance of the precautionary principle in the various activities it regulates. The regulation of all these matters has taken into account the provisions of Law 41/2002, 14 November, basic regulation of the autonomy of the patient and of rights and obligations regarding information and clinical documentation, and the Law Organic 15/1999, of December 13, of Protection of Personal Data, to which it is recognized their condition in addition in those matters not regulated by this Law.

From the point of view of the research action, the Law guarantees freedom of research and scientific production in the terms of Article 20 of our Constitution. In addition, such an ambitious legal framework on advanced research in the field of biomedicine could not fail to take into account the human, scientific, structural and social context in which it has to be developed in daily practice. Law regulates the mechanisms of promotion and promotion, planning, evaluation and coordination of biomedical research based on the principles of quality, effectiveness and equal opportunities and in order to promote the results of the Research is transformed into effective therapies to combat different pathologies. The implementation of research in health centers as a daily practice is facilitated, and the collaboration between basic biomedical research centers and hospitals and other centers of the System is encouraged. National Health and stimulate the links between the public and private sectors through network research and the mobility of researchers and practitioners.

From an organizational point of view, the Law creates a number of collegial bodies to which it recognizes a particularly qualified function based on impartiality, independence, technical capacity and professional competence. requires its members. On the one hand, the Research Ethics Committees must ensure in each institution that the adequacy of the methodological, ethical and legal aspects of research involving interventions in human beings or the environment is investigated. use of biological samples of human origin. The Commission of Guarantees for the Donation and Use of Cells and Human Tissue is responsible, for its part, to evaluate and inform preceptively and in favor of the research projects that require the obtaining or use of tissues, embryonic stem cells or other similar human origin obtained by various cellular reprogramming techniques that already exist or can be discovered in the future, as well as to develop other functions on scientific, ethical aspects and legal. Finally, the Bioethics Committee of Spain is created as the competent organ for the consultation of all those aspects with ethical and social implications of the field of Medicine and Biology and is called to fix the guidelines and principles general for the development of codes of good scientific research practices developed by the Research Ethics Committees.

III

The Law explicitly prohibits the constitution of human preembryos and embryos exclusively for the purpose of experimentation, according to the gradualist conception of the protection of human life sitting by our Court of Constitutional Court, in judgments such as 53/1985, 212/1996 and 116/1999, but allows the use of any technique of obtaining human embryonic stem cells for therapeutic or research purposes that does not carry the the creation of a preembryo or an embryo exclusively for this purpose and in the terms defined in the Law.

With regard to the use of supernumerary embryos of the techniques of assisted human reproduction, the starting point is the legal regime provided by Law 14/2006 of 26 May on techniques of human reproduction. assisted, which expressly prohibits so-called reproductive human cloning.

IV

The broad and complex set of matters regulated by the Law is contained in ninety articles, fifteen chapters, eight titles, three additional provisions, two transitional, one repeal and five endings.

The general provisions of Title I mark the guiding and guiding axis of the Law. The purpose and scope of the Law are defined and a catalogue of principles and guarantees for the protection of the rights of individuals and legal goods involved in biomedical research is established.

In relation to the object and scope of the standard, it is nuanced that the biomedical research referred to in the standard covers basic research and the clinic, excluding clinical trials with drugs and the implant of organs, tissues and cells, which shall be governed by specific rules.

With regard to the system of guarantees, a precise relationship is gathered that sets the limits of the principle of freedom of research in the defense of the dignity and identity of the human being and in the protection of their health, and they regulate It specifies the informed consent and the right to information, the protection of personal data and the duty of confidentiality, non-discrimination on the basis of genetic reasons or the renunciation of the practice of genetic analysis or participation in an investigation, the gratuitousness in the donation and use of biological samples, the guarantee of traceability and safety in the use of cells, tissues and any biological material of human origin and, finally, the limits to be respected in genetic analysis are established.

In addition, the criteria of quality, effectiveness and equality to which biomedical research must respond are regulated, and the Biomedical Research Committees are created as fundamental instruments of evaluation and monitoring of the research projects. Finally, Article 3 contains a broad catalogue of definitions which, supported by scientific, technical and legal knowledge, aim to define some relevant concepts of the Law.

The first specific matter of the Law, contained in Title II, is dedicated to biomedical research involving invasive procedures in human beings, excluding the purely observational ones. This regulation completes the regulatory framework of our legal system on research in which human beings are direct participants, which already has the specific regulation of clinical trials with drugs and medical devices.

In its five chapters, first, the general principles in which these investigations should be developed are regulated, with explicit references to the consent and the precise information to be provided to the subjects. (a) the Commission, in the light of the findings of the European Council of the European Union, the European Commission, the European Commission, the European Commission, the European Commission, the European Commission, the European Commission, the European Commission, the European Commission invasive procedures in human beings; third, they are regulated The specificities of the investigation during pregnancy and lactation, in the case of minors and unable and in the case of the investigation in persons unable to give their consent due to their clinical situation.

The fourth chapter of this title regulates the systems of safety and supervision in the research process, with specific references to the evaluation of the health status of the participants in the research, the interference in the clinical interventions of these and the system of checks which, under the supervision of the Research Ethics Committee, should be carried out during the course of the investigation. The last chapter of the title, finally, lays down the obligation to inform the participants of the research of the relevant data for their health which can be obtained during their development, as well as the obligation to give their results.

In Title III, with two chapters, the regulation of the donation and use of human embryos and fetuses, of their cells, tissues or organs, is collected with two main objectives. The first of these, to review and update the legal regime that governed prior to the entry into force of this Law, in particular with Law 42/1988, of December 28, of donation and use of embryos and human fetuses or of their cells, tissues the second, to incorporate such a matter into the overall approach of the new Law, in order to eliminate unnecessary regulatory dispersions related to biomedical research. As a result, the repeal of Law 42/1988 of December 28, which constituted a legislative novelty of relief in our legal order and was a recognized reference in the comparative law.

The title is structured in two chapters. The first one regulates the conditions for the donation of embryos and human fetuses, among them the prohibitions that the interruption of the pregnancy can be intended for the donation and that the professionals members of the medical team that I realized the termination of pregnancy is involved in the use of the embryos or aborted fetuses, and establishes for the validity of the donation that the informed consent of the donor and the expulsion in the pregnant woman of the embryos are present; or fetuses without the possibility of maintaining their life autonomy. The second chapter states that research with live embryos and foetuses in the womb may only be carried out for diagnostic or therapeutic purposes in their own interest and lays down the conditions for the authorization of research projects. with embryos, foetuses and their biological structures.

In Title IV, the regulation of donation, use and research with cells and tissues of human embryonic origin and other similar cells is carried out in full compliance with the provisions of Law 14/2006 of 26 May, on assisted human reproduction techniques, which already regulates the donation of leftover oocytes and in vitro preembryos, the application of assisted reproductive techniques as well as the requirements for the use of such preembryos or their biological structures for the purpose of research or experimentation, and without prejudice to the prescriptive a favourable report to be issued to the Commission on Guarantees for the Donation and Use of Human Cells and Tissue and the conditions, guarantees and requirements imposed in the first two chapters of Title IV.

In the first chapter of this Title, the constitution of human embryos and preembryos for experimental purposes is expressly prohibited and the use of any technique of obtaining human stem cells is authorized. for therapeutic or research purposes, including the activation of oocytes by nuclear transfer, which does not involve the creation of a preembryo or an embryo in the terms defined in the Law. In the second chapter, the conditions under which research with biological samples of an embryonic nature should be carried out are regulated, and the composition and functions of the aforementioned Guaranty Commission are determined in the third. It is also appropriate to report on the investigations listed in the Law relating to tissues and stem cells or other functionally similar or to procedures and techniques for obtaining them, including stem cell lines Embryonic stem cells from third countries. Finally, in the fourth chapter, which establishes the system of promotion and coordination in this field of research with cells and tissues of human embryonic origin, the regulation of the National Bank of Cellular Lines, which is recognizes a structure in the form of a network, with a central node, and an attachment to the Carlos III Health Institute.

Title V regulates other emerging subjects related to the current expansive trend of biomedical research such as the carrying out of genetic analysis, access and use of their results, as well as use of biological samples of human origin. In spite of the enormous difficulties in dislinking the limits that frame research and diagnosis in the field of genetic analysis, for reasons of substantive and systematic coherence and attention to the important rights of the persons who may be involved in this type of analysis, this Law could not give up the legal framework in which the conduct of genetic analysis is to be placed for any purpose, including the diagnosis.

In this respect, the Law, while prescribing a set of guarantees in relation to genetic analysis and biological samples within the scope of the protection of personal data, configures a set of standards to give confidence and security to researchers and public and private institutions in their actions in the sector, clearing current legal uncertainties. In addition to other normative principles already mentioned, the principles of accessibility, equity and quality in the treatment of data are marked as guiding principles. Prior consent is required and the situation of biological samples is foreseen. anonymised. Finally, specific rules are provided for in relation to deceased persons and preembryos, embryos and foetuses, in respect of which data protection is also guaranteed and the duty of confidentiality is imposed. It is also worth highlighting the regulation by the Law of the need for accreditation of centers and people capable of carrying out genetic analysis.

The regime for the obtention, conservation, use and disposal of biological samples is also the subject of a detailed regulation in the third chapter of this title. As is logical, the legal framework is again based on the consent of the source of the sample and on the prior information that should be provided to it. As regards the choice of the possibility of granting a completely generic or specific consent on the use or subsequent uses of the sample, the Law has opted for an intermediate and flexible regime, in the sense that the initial consent may cover, if provided for in the information previously provided to the source, subsequent investigations relating to the initial subject, including investigations which may be carried out by third parties and disposals to these of identified or identifiable data or samples. In any case, a transitional regime has been provided for the biological samples obtained for any purpose prior to the entry into force of this Law, in order not to hinder their use for the investigation, the same time for the interests of the source subjects.

In close relation to the use of samples of human origin, the Law defines and clarifies the legal status of biobanks and the differences in other collections of biological samples that may exist for the purposes of Biomedical research, without prejudice to the fact that in both cases it must be registered in the National Register of Biobanks. The single registration system, whatever the purpose of the bank, is established, including the purposes of clinical use in patients, exclusively or shared with the research, and without prejudice to the specific measures required to be regulated for the operation of each bank according to its respective nature and purpose. It is also established that the authorization of the creation of biobanks will be the responsibility of the competent bodies of the corresponding autonomous community, except for the initiatives that the Carlos III Health Institute can take on the creation of banks. Nationals of biological samples for research purposes in the general interest, in which case the authorisation shall be the responsibility of the Ministry of Health and Consumer Affairs.

Title VI provides for the regime of administrative infringements and sanctions based on the principles of legality, minimum intervention, proportionality and subsidiarity in respect of the criminal offence. The specific infringements included in the Law are complemented by the provisions of Law 14/2006 of 26 May on assisted human reproduction techniques, without prejudice to those which are also applicable from the General Law of Health and other provisions laid down in the regulations of the Autonomous Communities and in the regulations on the protection of personal data.

The law also seeks to respond to the need for a state body such as the Bioethics Committee, which is fundamentally consultative on matters related to ethical, legal and social implications. In addition, he represents Spain in the forums and supranational and international organizations involved in the Bioethics, and collaborates with other state and regional committees with advisory functions on these matters. Title VII of the Law sets out the provisions on its composition and operation, which seeks to guarantee its independence by appointing its members to accredited persons who are qualified from the scientific, legal and bioethical.

Finally, Title VIII of the Law, particularly relevant, is dedicated to the promotion and coordination of biomedical research in the National Health System in relation to the elaboration of the sector initiative within of the National Plan for Scientific Research, Development and Technological Innovation. In addition to this, and in response to repeated demands of certain collective researchers, the aim is to better regulate the promotion and coordination of biomedical research in Spain. In order to achieve both objectives, an instrumental normative framework is created for the promotion of scientific research of excellence, aimed at solving the health needs of the population, and in particular the clinical practice based on the scientific knowledge within the structures of the National Health System, recognizing the centers that integrate it the capacity to hire personnel dedicated to research activities and opening the possibility that the activity researcher is an integral part of the professional career of statutory staff. In addition, mobility measures are established for research staff within the General Administration of the State and towards private research entities through temporary leave.

Additionally, cooperation between the public and private sectors is strengthened through, among other measures, the collaboration and participation of private entities in the implementation of the System's research actions. National Health and establishes the possibility for the staff of these private entities to participate in the execution of programs or research projects of the National Health System.

Among the provisions that close the article of the Law deserves special mention the additional second, which reviews and updates the regulation of the Health Institute Carlos III as a fundamental instrument of the General Administration of the State for the promotion of biomedical research.

The various provisions and regulations provided by this Law provide for an innovative, comprehensive and largely adaptable regulatory package to the circumstances and situations in which the investigation is likely to occur. In the coming years. It is a normative instrument that, while complying with its claim to guarantee the rights and legal assets involved in biomedical research, constitutes a decisive support for the development of public policies and Private initiatives that must promote advanced and competitive biomedical research in our scientific environment and in a clear legal framework that allows for efficiency and quality in research.

TITLE I

General provisions

Article 1. Object and scope of application.

1. This Law is intended to regulate, with full respect for human dignity and identity and the inherent rights of the person, biomedical research and in particular:

a) Human health-related research involving invasive procedures.

b) The donation and use of oocytes, sperm, preembryos, embryos and human fetuses or their cells, tissues, or organs for biomedical research purposes and their potential clinical applications.

c) The treatment of biological samples.

d) The storage and movement of biological samples.

e) Biobanks.

f) The Bioethics Committee of Spain and the other bodies with competence in the field of biomedical research.

g) The mechanisms for promoting and promoting, planning, evaluating and coordinating biomedical research.

2. Likewise and exclusively within the health field, this Law regulates the conduct of genetic analysis and the processing of genetic data of a personal nature.

3. The biomedical research referred to in this Law includes basic and clinical research, with the exception in the latter case of clinical trials with medicinal products and medical devices, which will be governed by their regulations. specifies.

4. The implantations of organs, tissues and cells of any origin that will be governed by the provisions of Law 30/1979 of 27 October on the extraction and transplantation of organs and other applicable regulations are excluded from the scope of this Law.

Article 2. Principles and guarantees of biomedical research.

The realization of any biomedical research activities included in this Law will be subject to the following guarantees:

(a) The protection of the dignity and identity of the human being will be ensured with respect to any research involving interventions on human beings in the field of biomedicine, guaranteeing every person, without discrimination, respect for integrity and other fundamental rights and freedoms.

b) The health, interest and well-being of the human being involved in biomedical research will prevail above the interest of society or science.

(c) Investigations from human biological samples shall be carried out in the framework of respect for fundamental rights and freedoms, with guarantees of confidentiality in the processing of personal and personal data. biological samples, in particular in the conduct of genetic analysis.

d) Freedom of research and scientific production in the field of biomedical sciences will be guaranteed.

e) The authorization and development of any research project on human beings or their biological material will require the prior and mandatory report of the Research Ethics Committee.

f) The research will be developed in accordance with the precautionary principle to prevent and avoid risks to life and health.

g) The investigation should be evaluated.

Article 3. Definitions.

For the purposes of this Law:

(a) "Genetic analysis" means a procedure to detect the presence, absence or variants of one or more segments of genetic material, including indirect tests to detect a gene product or a metabolite specific that is indicative of a particular genetic change.

b) "Genetic-population analysis": research that aims to understand the nature and magnitude of genetic variations within a population or between individuals in the same group or different groups.

(c) "Anonymization" means a process by which it is no longer possible to establish by reasonable means the link between a data and the subject to which it refers. It is also applicable to the biological sample.

d) "Biobank": public or private, non-profit establishment, which hosts a collection of biological samples conceived for diagnostic or biomedical research purposes and organized as a technical unit with criteria of quality, order, and target.

(e) "Genetic Council" means a procedure to inform a person about the possible consequences for him or his offspring of the results of a genetic screening or screening and its advantages and risks and, where appropriate, advise on the possible alternatives derived from the analysis. It takes place both before and after a test or genetic screening and even in the absence of them.

(f) "Consent" means a manifestation of the free and conscious will validly issued by a capable person, or by his authorized representative, preceded by adequate information.

g) "Genetic screening": a public health programme, aimed at identifying individuals with genetic determinants, for whom early medical intervention could lead to the elimination or reduction of mortality, morbidity or disabilities associated with such determinants.

h) "Anonymous Dato": data recorded without a link to an identified or identifiable person.

i) "Anonymized or irreversibly dissociated Dato": data that cannot be associated with a person identified or identifiable for having destroyed the nexus with all information identifying the subject, or because such association requires an unreasonable effort, understanding the use of an amount of time, expenses and disproportionate work.

(j) "genetic DNA of a personal nature" means information on the hereditary characteristics of a person, identified or identifiable by analysis of nucleic acids or other scientific analyses.

k) "Dato encoded or reversibly disassociated": data not associated with a person identified or identifiable as the information identifying the person using a code that permits the operation has been replaced or unlinked inverse.

l) "Embrion": the phase of embryonic development that ranges from the moment when the fertilised egg is in the womb of a woman until the start of the organogenesis occurs, and ends at 56 days from from the time of the fertilisation, except for those days when the development could be stopped.

m) "observational study": a study conducted on individuals for whom the treatment or intervention is not modified or is prescribed any other pattern that may affect their treatment. personal integrity.

n) "Feto": embryo with human appearance and with its formed organs, which is maturing from the age of 57 days from the moment of fertilization, except for the computation of those days in which the development could have been stopped, until the moment of delivery.

(o) "biological sample" means any biological material of human origin susceptible to conservation and which may contain information on the genetic endowment characteristic of a person.

p) "Anonymized or irreversibly dissociated biological sample": shows that it cannot be associated with a person identified or identifiable for having destroyed the nexus with all information identifying the subject, or because association requires an unreasonable effort.

q) "Non-identifiable or anonymous biological sample": shows collection without a nexus with an identified or identifiable person from which, consequently, the provenance is not known and it is impossible to trace the origin.

r) "Encoded or reversibly dissociated biological sample": shows not associated with a person identified or identifiable as having been replaced or disassociated with the information identifying that person using a code that allow the reverse operation.

s) "Preembryo": the in vitro constituted embryo formed by the cell group resulting from the progressive division of the ovocyte since it is fertilised up to 14 days later.

t) "invasive procedure" means any intervention carried out for the purpose of research involving a physical or mental risk to the affected subject.

u) "Minimum risk and burden": the health impacts and the discomfort that may be experienced by the participants in an investigation, and the effects of which may only be mild and temporary.

v) "Source Subject": living individual, whatever their health status, or deceased from which the biological sample comes from.

w) "Treatment of genetic data of a personal character or biological samples": operations and procedures for obtaining, conserving, using and transferring genetic data of a personal nature or samples biological.

x) "Traceability" means the ability to associate a particular biological material with recorded information referred to each step in the chain of its procurement, as well as throughout the entire research process.

Article 4. Informed consent and right to information.

1. The free autonomy of persons who may participate in a biomedical research or who may contribute to their biological samples shall be respected, for which it shall be necessary for them to have previously given their express and written consent once received the appropriate information.

The information shall be provided in writing and shall include the nature, importance, implications and risks of the investigation, in the terms set out in this Law.

Information will be provided to people with disabilities in accessible conditions and formats appropriate to their needs.

If the subject of the investigation is unable to write, the consent may be given by any means admitted in law to allow the person to record his or her will.

2. Consent shall be granted by representation where the person is legally incapacitated or minor, as long as there are no other alternatives for the investigation.

The provision of consent by representation shall be proportionate to the research to be developed and shall be carried out with respect to the dignity of the person and for the benefit of his or her health.

The disabled and minors will participate as far as possible and according to their age and capacity in decision-making throughout the research process.

3. Persons participating in a biomedical investigation may revoke their consent at any time, without prejudice to the limitations established by this Law. Persons or entities having received such consent shall have the necessary measures for the effective exercise of this right.

4. The lack of consent or the revocation of the consent previously granted shall not cause any harm to the health care of the subject.

5. Every person has the right to be informed of his genetic and other personal data obtained in the course of a biomedical research, according to the terms in which he manifested his will. The same right is recognised for the person who has provided, for the purpose indicated, biological samples, or where other biological materials have been obtained from them.

The right of the person to decide that the data referred to in the previous paragraph shall not be communicated to him shall be respected, including any unexpected discoveries that may occur. However, where this information, according to the opinion of the responsible doctor, is necessary to avoid serious harm to his or her health or to his/her biological relatives, a family member or representative shall be informed, after consultation of the committee. assistance if there were. In any event, the communication shall be limited exclusively to the data necessary for these purposes.

Article 5. Protection of personal data and confidentiality guarantees.

1. The protection of personal privacy and the confidential treatment of personal data resulting from the activity of biomedical research shall be ensured, in accordance with the provisions of the Organic Law 15/1999 of 13 December, of Protection of Personal Data. The same guarantees shall apply to biological samples which are a source of personal information.

2. The transfer of personal data to third parties other than medical-care or biomedical research shall require the express and written consent of the person concerned.

In the event that the data obtained from the source may reveal personal information of their relatives, the assignment to third parties will require the express and written consent of all interested parties.

3. The use of data relating to the health of persons for purposes other than those for which consent was provided is prohibited.

4. Any person who, in the exercise of his or her duties in relation to a medical-care performance or a biomedical research, whatever the scope of his or her own, is subject to the duty of secrecy shall be subject to the obligation of secrecy. personal character. This duty will persist even after the investigation or action has ceased.

5. If it is not possible to publish the results of an investigation without identifying the person who participated in the investigation or who provided biological samples, such results may only be published when the prior and express consent has been mediated. of that.

Article 6. Non-discrimination.

No one will be subjected to any discrimination because of its genetic characteristics. A person may also not be discriminated against because of his refusal to undergo a genetic analysis or to give his consent to participate in a biomedical research or to donate biological materials, in particular in relation to the provision of Medical-care provided to you.

Article 7. Gratuity.

The donation and use of human biological samples will be free of charge, regardless of their specific origin, without in any case the compensation provided for in this Law. commercial.

The donation also implies the waiver by donors of any right of an economic or other nature to the results that could be derived directly or indirectly from the investigations that are carry out such biological samples.

Article 8. Traceability and security.

The traceability of cells, tissues and any biological material of human origin must be ensured in order to ensure quality and safety standards, respecting the duty of confidentiality and the provisions of the Organic Law. 15/1999, of 13 December, Protection of Personal Data.

In the case of research with cells and tissues intended for human use, data to ensure traceability should be maintained for at least 30 years.

Activities related to biomedical research will be conducted with strict observance of the precautionary principle, in order to prevent serious risks to human life and health.

Article 9. Limits of genetic analysis.

1. The protection of the rights of persons in the conduct of genetic analysis and the processing of genetic data of a personal nature in the health field shall be ensured.

2. Genetic analyses will be carried out with criteria of relevance, quality, equity and accessibility.

3. Only predictive tests of genetic diseases or which make it possible to identify the subject as a carrier of a gene responsible for a disease, or to detect a genetic predisposition or susceptibility to a disease, for medical purposes may be made. or medical research and with a genetic assessment, when indicated, or in the case of the study of the inter-individual differences in the response to drugs and genetic-environmental interactions or for the study of the bases molecular diseases.

Article 10. Promotion and quality of biomedical research.

1. The promotion of biomedical research will meet criteria of quality, effectiveness and equal opportunities.

2. Any research of a biomedical nature must be scientifically justified, meet the generally accepted scientific quality criteria and be carried out in accordance with the appropriate professional obligations and standards, under the supervision of a scientifically qualified researcher. It will also be evaluated at completion.

Article 11. Input and output of biological samples.

The intra-Community and non-Community entry and exit of biological samples of human origin for the purposes of biomedical research referred to in this Law shall be governed by the provisions laid down in this Law. regulentarily.

In the case of biological samples from biobanks, the conditions of disposal and security provided for in Title V of this Law shall be observed.

Article 12. Research Ethics Committees.

1. The Research Ethics Committees for the centres conducting biomedical research shall be duly accredited by the competent body of the appropriate autonomous community or, in the case of centres dependent on the General government of the State, by the competent body of the State, to ensure its independence and impartiality.

For the accreditation of a Research Ethics Committee, at least the following criteria shall be weighted: the independence and impartiality of its members with respect to the promoters and researchers of the research projects biomedical research, as well as its interdisciplinary composition.

The competent authorities may arrange for the creation of Research Ethics Committees to develop their functions in two or more centers that conduct biomedical research.

2. The Research Ethics Committee for the Centre shall perform the following tasks:

a) Evaluate the qualification of the principal investigator and the investigator team as well as the feasibility of the project.

b) Pondering the methodological, ethical and legal aspects of the research project.

c) Pondering the balance of risks and anticipated benefits of the study.

(d) To ensure compliance with procedures to ensure the traceability of samples of human origin, without prejudice to the provisions of personal data protection legislation.

e) To inform, after evaluation of the research project, any biomedical research involving interventions in human beings or the use of biological samples of human origin, without prejudice to other reports be issued. The research project may not be authorised or developed without the prior and prescriptive favourable report of the Research Ethics Committee.

f) Develop codes of good practice in accordance with the principles established by the Bioethics Committee of Spain and manage the conflicts and files that their default generates.

g) Coordinate your activity with that of similar committees of other institutions.

h) Ensure confidentiality and exercise how many other functions may be assigned to them by the law of development of this Law.

3. For the performance of their duties, the Research Ethics Committees may require the information they require, and in particular the information to be given on the sources and the amount of funding for the studies and the distribution of expenditure.

4. The members of the Research Ethics Committees shall make statements of activities and interests and shall refrain from taking part in the deliberations and in the votes in which they have a direct or indirect interest in the matter. examined.

TITLE II

Investigations involving invasive procedures in humans

CHAPTER I

General principles and requirements for information and consent

Article 13. Consent.

The conduct of an investigation of a person shall require the express, specific and written consent of that person, or of his legal representative, in accordance with the general principles set out in Article 4 of this Agreement. Law.

Article 14. General principles.

1. Human research can only be carried out in the absence of an alternative of comparable efficacy.

2. The investigation shall not involve any disproportionate risks and inconvenience to the human being in relation to the potential benefits to be obtained.

3. Without prejudice to the above paragraph, where the investigation does not have the possibility of producing results of direct benefit to the health of the subject participant in the investigation, it may only be initiated in the event of a representative a minimum risk and a minimum burden for that subject, in the opinion of the Research Ethics Committee to assess the investigation.

Article 15. Information to the subjects participating in the research.

1. Persons who are requested to participate in a research project shall receive the necessary information in advance, duly documented and in an understandable manner and in the case of persons with disabilities in an appropriate manner to their circumstances.

2. The information will include the purpose, detailed plan, inconvenience and potential risks and benefits of the investigation. This information shall specify the following:

(a) Nature, extent and duration of the procedures to be used, in particular those affecting the participation of the subject.

b) Preventive, diagnostic and therapeutic procedures available.

c) Measures to respond to adverse events as regards the subjects involved in the investigation.

(d) Measures to ensure respect for private life and the confidentiality of personal data in accordance with the requirements of personal data protection legislation.

e) Measures to access, in the terms of Article 4.5, relevant information for the subject, arising from the investigation or the total results.

f) Measures to ensure adequate compensation in case the subject suffers any damage.

g) Identity of the professional responsible for the investigation.

h) Any future potential use, including commercial ones, of research results.

i) Source of funding for the research project.

In the event that these extremes are not known, there will be an explicit commitment to complete the information when the data is available.

3. In the event that the future or simultaneous use of genetic data or biological samples has been foreseen, the provisions of Chapters II and III of Title V of this Law shall apply.

4. In addition, persons who are requested to participate in an investigation shall be informed of the rights and safeguards prescribed in the Law for their protection and, specifically, their right to refuse consent or to withdraw it in any time without which their right to health care may be affected for that reason.

CHAPTER II

Evaluation, authorization, and damage assurance

Article 16. Assessment and authorisation.

All biomedical research that carries out some invasive procedure in the human being must be previously evaluated by the Research Ethics Committee of the research project presented and authorized. by the competent regional body. The assessment shall be prior to authorisation, favourable and duly substantiated and shall take into account the scientific suitability of the project, its relevance, feasibility and the adequacy of the principal investigator and the research team.

In case the partial results obtained advise a modification of the project, such modification will require a favorable report of the Research Ethics Committee and will be communicated to the competent autonomic authority for the appropriate purposes.

In the case of research projects that are carried out in several centers, the unit of criterion and the existence of a single report will be guaranteed.

Article 17. Control and monitoring guarantees.

1. The conduct of the investigation shall in any event be adjusted to the content of the project to which the authorisation would have been granted.

2. The health authorities will have at all times inspecting the research, being able to have access to the individual clinical histories of the subjects of the study, for which they will have to keep in any case their character confidential.

3. The autonomic authority shall, on its own initiative or at the request of the Research Ethics Committee, proceed to the precautionary suspension of the investigation authorized in cases where the requirements laid down in this Law have not been observed. is necessary to protect the rights of citizens.

Article 18. Compensation for damages and their insurance.

1. Persons who have suffered damage as a result of their participation in a research project shall receive the appropriate compensation in accordance with the following paragraphs.

2. The conduct of an investigation involving an invasive procedure in human beings shall require prior assurance of the damage and damage that may arise from that for the person in which it is carried out.

3. Where, for all circumstances, the insurance does not cover entirely the damage caused, the sponsor of the investigation, the investigator responsible for the investigation and the hospital or centre in which it has been carried out shall be jointly and severally liable for those damages, Even if it does not measure guilt, it is the burden of proof. Neither the administrative authorisation nor the report of the Research Ethics Committee shall exempt them from liability.

4. It is presumed, unless proof to the contrary, that the damage affecting the health of the person subject to the investigation, during its performance and in the year following its termination, has occurred as a result of the investigation. However, upon completion of the year, the subject of the year shall be obliged to prove the damage and the link between the investigation and the damage produced.

5. The other aspects relating to liability for damages and their insurance shall apply the provisions of the legislation on guarantees and the rational use of medicinal products and medical devices.

CHAPTER III

Specific situations

Article 19. Pregnancy and breast-feeding research.

1. Only an investigation involving a pregnant woman may be authorised, in respect of which the said investigation is not intended to produce a direct benefit, or to the embryo, the foetus, or the child after birth, if they are met. the following conditions:

(a) That the research is aimed at contributing to the production of results that benefit other women, embryos, fetuses or children.

b) It is not possible to conduct comparable efficacy investigations in women who are not pregnant.

(c) That the investigation involves a minimum risk and injury to the woman and, where appropriate, to the embryo, the fetus or the child.

d) That the child's pregnant or legal representatives, if any, consent to the terms provided for in this Law.

2. When the investigation is carried out in a woman during the breast-feeding period, special care should be taken to avoid an adverse impact on the child's health.

Article 20. Protection of persons who do not have the capacity to express their consent.

1. The investigation of a minor or unable to act, except that, in consideration of his or her degree of discernment, the judicial decision of incapacitation entitle him to give his consent to the investigation, may only be carried out if the following conditions are met:

a) That the results of the research can produce real or direct benefits for your health.

b) That comparable efficacy research cannot be performed on individuals able to grant their consent.

c) That the person who is to participate in the investigation has been informed in writing of his or her rights and of the limits prescribed in this Law and the regulations that he develops for his protection, unless that person is not in situation of receiving the information.

(d) that the legal representatives of the person who is to participate in the investigation have given their written consent, having received the information set out in Article 15. Legal representatives shall take into account the wishes or objections previously expressed by the person concerned. In these cases, it will also be used in accordance with the provisions of Article 4 (1) of this Law.

2. Where it is foreseeable that the investigation is not going to produce results for the direct benefit of the health of the subjects referred to in paragraph 1 of this Article, the investigation may be exceptionally authorised if they are in addition to the requirements contained in paragraphs (b), (c) and (d) of the preceding paragraph, the following conditions:

(a) That the research has the object of contributing, through significant improvements in the understanding of the disease or condition of the individual, to a beneficial outcome for other persons of the same age or with the same disease or condition, within a reasonable time.

b) That the research involves a minimum risk and burden for the participating individual.

c) That the authorization of the investigation be brought to the attention of the Fiscal Ministry.

Article 21. Research in people unable to consent due to their clinical situation.

1. In order to carry out an investigation in emergency clinical situations where the person concerned cannot give his consent, the following specific conditions must be met:

a) That it is not possible to conduct comparable efficacy investigations in people who are not in that emergency situation.

b) That in the event that the research is not expected to produce results beneficial to the health of the patient, it is intended to contribute to significantly improving the understanding of the disease or the condition of the patient, with the aim of benefiting other persons with the same disease or condition, as long as it leads to the minimum risk and discomfort for the patient.

c) That the authorization of the investigation be brought to the attention of the Fiscal Ministry.

2. Any objection previously expressed by the patient who is known to the physician responsible for their care, by the investigator or by the Research Ethics Committee for the center will be respected.

3. For the purposes of the first paragraph of this article, investigations are considered in emergency situations, in which the person is not in a position to grant his consent and, because of his or her state and the urgency of the situation, it is impossible to obtain in time the authorization of the legal representatives of the patient or, if they lack them, of the people who would live with him.

4. Persons who participate in an emergency investigation or, where appropriate, their legal representatives, shall be informed as soon as possible in the terms set out in Article 4 of this Law. Consent must also be sought to continue to participate in the investigations, as soon as the patient is in a position to lend.

CHAPTER IV

Security and monitoring

Article 22. Risk prevention.

1. In addition to the provisions of Article 18, the necessary measures will be taken to ensure the safety of the research and to reduce the risks and discomforts for the individuals involved.

Medical decisions related to the health of the subjects involved in the research correspond to the physician responsible for their care.

2. The investigator responsible for the project shall demonstrate that the members of the research team have the appropriate qualification and experience in the field of the proposed research.

Article 23. Assessment of the health status.

1. People who are going to participate in the research have a duty to provide the real data about their physical state or health. In any event, the investigator shall take the necessary measures, including, where appropriate, the consultation of the physicians responsible for the assistance of the participants, in order to verify these extremes prior to the initiation of the investigation, with the purpose of ensuring that persons for whom the special risk journal research is excluded from it.

2. Where the investigation involves women of childbearing potential, account shall be taken of the potential adverse impact on an existing or unknown pregnancy, as well as on the health of the embryo, foetus or child.

Article 24. No interference with necessary clinical interventions.

1. The investigation shall not delay or deprive participants of the preventive, diagnostic or therapeutic medical procedures that are necessary for their health status.

2. In the case of research associated with the prevention, diagnosis or treatment of diseases, it should be ensured that the participants assigned to the control groups receive proven procedures for prevention, diagnosis or treatment.

The investigator shall record the extremes referred to in the preceding paragraph in the test protocol to be submitted for evaluation and authorization.

3. Use of placebo may be used only if there are no proven methods of efficacy, or where the withdrawal of such methods does not present an unacceptable risk or injury to the patient.

Article 25. Checks on the course of the investigation.

1. The Research Ethics Committee shall take appropriate measures to ensure that the continuity of the project is justified in the light of new knowledge that is achieved throughout its implementation.

The principal investigator shall forward to the Committee without delay any information relevant to the safety of the participating subjects.

2. The purpose of the verification referred to in the preceding paragraph shall be to determine:

a) Whether it is necessary to interrupt the investigation or make changes to the project so that it can continue.

b) If the participants in the investigation or, if appropriate, their representatives, should be informed about the events that may occur.

c) If additional consent is required of the participants.

3. Any modification in the conditions authorized for a research project deemed relevant may not be carried out without the prior favorable opinion of the Research Ethics Committee and the approval of the competent.

4. Any relevant information on the participation in the investigation shall be communicated in writing to the participants or, where appropriate, their representatives, as soon as possible.

5. The Research Ethics Committee shall follow up compliance with the provisions of the previous paragraph, and shall take account of the incidents which it has observed to the competent authority which gave the authorization for such investigation, with the purpose of the latter being able to take the appropriate measures, in accordance with Article 17 of this Law and in full compliance with the provisions of the current legislation on the protection of personal data.

6. The investigator responsible shall inform the Research Ethics Committee and the competent authority which has given its conformity to the investigation of the reasons why it decides to terminate any research project prematurely.

CHAPTER V

Managing information

Article 26. Duty to report.

According to the provisions of Article 4.5, if the investigation results in information relevant to the health of the participants, it must be made available to them, which will be effective in the framework of the assistance in progress or, in its defect, providing specific advice.

Article 27. Information about the results.

1. Upon completion of the investigation, the responsible investigator shall submit a summary of the investigation to the competent authority which gave the authorisation and to the Research Ethics Committee.

2. The results of the investigation shall be communicated to the participants, provided they so request.

3. The researchers will have to make public the general results of the investigations once they have been completed, taking into account the requirements relating to the personal data referred to in Article 5.5 of this Law and without prejudice to the corresponding intellectual and industrial property rights that could be derived from the investigation.

TITLE III

On the donation and use of human embryos and fetuses, of their cells, tissues, or organs

CHAPTER I

Donation of human embryos and fetuses

Article 28. Donation of human embryos and foetuses.

1. Human embryos which have lost their biological development capacity, as well as dead human embryos or foetuses, may be donated for the purposes of biomedical research or other diagnostic, therapeutic, pharmacological, clinical or surgical.

2. The termination of pregnancy will never be intended to provide for the donation and subsequent use of embryos or foetuses or their biological structures. The procedure and mode of practice of termination of pregnancy shall be subject only to the legal requirements and limitations and to the characteristics and circumstances of the pregnancy.

Professional members of the medical team who perform the termination of pregnancy will not intervene in the use of the embryos or aborted fetuses or their biological structures. To this end, the members of the research team will give written record of this circumstance, as well as the absence of conflict of interest with the medical team.

3. The premature and spontaneously expelled fetuses will be treated clinically while maintaining their biological viability, with the sole aim of promoting their development and life autonomy.

4. Prior to any intervention on human embryos which have lost their biological development capacity or dead embryos or foetuses, the relevant optional staff shall be kept on the record. circumstances.

Article 29. Requirements regarding donation.

1. In addition to the provisions of the previous article, the donation of human embryos or foetuses or their biological structures for the purposes provided for in this Law shall meet the following requirements:

(a) That the donor or donor of the embryos or foetuses has previously granted their consent in writing and in an express manner. If any of those were less than emancipated or incapacitated, the consent of their legal representatives will also be necessary.

b) That the donor or donors or, where appropriate, their legal representatives, have been informed in writing, prior to giving their consent, of the purposes to which the donation may be used, of the consequences of the donation; as well as the interventions to be performed to extract embryological or foetal cells or structures, from the placenta or the wrappers, and from the risks that may arise from such interventions.

c) That the expulsion, spontaneous or induced, occurred in the pregnant woman of such embryos or foetuses, and it has not been possible to maintain their life autonomy as provided for in Article 28.3.

d) That the donation and subsequent use is never lucrative or commercial.

2. In the event that the persons from whom the embryos or foetuses have died, it will be necessary for the express opposition to be recorded. If the deceased is a minor or an incapacitated person, the donation will take place unless the express opposition of those who exercised their legal representation is recorded.

CHAPTER II

Conditions for biomedical research with human embryos and fetuses

Article 30. Limitations to research with live embryos and fetuses in the womb.

Only interventions on the living embryo or fetus in the womb may be authorised when they have a diagnostic or therapeutic purpose in their own interest, without prejudice to the legal provisions of the interruption. voluntary of pregnancy.

Article 31 Usage Requirements.

1. Research on human embryos or foetuses or on their biological structures shall meet the following requirements:

(a) In the case of embryos or foetuses found in one of the situations referred to in Article 28 (1) of this Law.

(b) The donation of embryos and foetuses to be used under the conditions provided for in Article 29 of this Law.

c) A project to be developed concerning the use that is intended to be carried out and has the favorable report of the Commission of Guarantees for the Donation and Use of Cells and Human Tissue.

d) That the corresponding regional or regional authority has given its authorisation to the intended use.

2. The team responsible for the approved project must report the result of the project to the body that gave its consent to the project submitted, as well as to the Commission of Guarantees for the Donation and Use of Cells and Human Tissue.

TITLE IV

On obtaining and using cells and tissues of human embryonic origin and other similar cells

CHAPTER I

On the use of oocytes and preembryos

Article 32. Donation of oocytes and preembryos.

1. Research with oocytes and preembryos should have the consent of the persons from whom they come, which may revoke it at any time without affecting the research carried out.

2. The donation of oocytes and preembryos shall be governed by the provisions of Law 14/2006 of 26 May on assisted human reproduction techniques.

In the case of oocytes, the consent of the donors shall refer to their authorization for the use of the specific technique or techniques to be applied to the oocytes that are the subject of the donation. To this end, healthcare professionals responsible for obtaining such oocytes will provide donors with timely information to grant consent, and the written record of all such information should be kept.

Article 33. Obtaining cells of embryonic origin.

1. The establishment of pre-embryos and human embryos exclusively for the purpose of experimentation is prohibited.

2. The use of any technique of obtaining human stem cells for therapeutic or research purposes is permitted, which does not involve the creation of a preembryo or an embryo exclusively for this purpose, in the terms defined in this Act, including the activation of oocytes by nuclear transfer.

CHAPTER II

On research with biological samples of embryonic nature

Article 34. Guarantees and requirements for research.

1. Research or experimentation with oocytes and pre-embryos left over from the application of assisted reproductive techniques or their biological structures for the purpose of obtaining, developing and using lines embryonic stem cells or for other purposes not linked to the development and application of assisted reproductive techniques, shall be carried out in accordance with the conditions laid down in Law 14/2006 of 26 May, and comply with the requirements of this Directive. Following requirements:

(a) That the investigation respects the ethical principles and the applicable legal regime, in particular the provisions of this Law and its development regulations, and responds to the principles of relevance, feasibility and suitability, the principal investigator, the research team and the facilities of the centre where the research will be carried out.

b) Which is based on a research project approved by the competent state or regional authority, after a favourable report from the Commission of Guarantees for the Donation and Use of Cells and Human Tissue, in the case of projects in the areas referred to in Article 35.

2. The authorization of the research projects shall be conditional on the project incorporating at least the following elements:

(a) The authorization of the address of the center in which the investigation will be conducted, as well as the favorable report of the Research Ethics Committee that corresponds to it.

(b) An indication of the existing common interests and relationships of any nature, or the absence thereof, between the team and the centre that have carried out each of the assisted reproductive processes that have taken place generated the preembryos or intervened to obtain the oocytes.

(c) The written commitment to provide the relevant public authority with data to identify and understand the conservation of cell lines that could be obtained as a result of the development of the research.

d) The commitment of the assignment free of charge of the cell lines that can be obtained in the development of the research, for its use by other researchers.

e) In the case of the use of oocytes or preembryos, the indication and justification of their number and origin and the informed consent document signed by the donors or parents, respectively.

Article 35. Report of the Commission of Guarantees for the Donation and Use of Cells and Human Tissue.

1. They shall require the favourable prior report of the Commission of Guarantees for the Donation and Use of Cells and Human Tissue, the research projects that will be in whole or in part about the following subjects:

a) Research with human preembryos for the derivation of cell lines, for embryological research and for other uses of research, except those related to the development and application of assisted reproduction.

b) Research with human embryonic stem cells.

c) The activation of oocytes by nuclear transfer for use for therapeutic or research purposes.

(d) Any other technique which, using in whole or in part biological samples of human origin, may result in the obtaining of stem cells.

e) Research with embryonic cells or tissues obtained by any of the procedures outlined in Article 33.2.

f) Any other line of research that includes cellular material of human embryonic origin or other functionally similar.

g) Research with embryonic stem cell lines coming from another country, intra-Community or extra-Community. That source will be specified in the project submitted to report.

2. The authority which granted the authorization to the research projects referred to in the previous paragraph shall annually transfer its results to the Commission of Guarantees for the Donation and Use of Cells and Human Tissue.

Article 36. Access to oocytes and cryopconserved preembryos.

The Carlos III Health Institute will guarantee access to cryopconserved preembryos left over from assisted reproductive techniques that have been donated for research purposes. The same criteria will be followed with the donated oocytes for research.

CHAPTER III

About the Commission on Guarantees for the Donation and Use of Cells and Human Tissue

Article 37. Establishment of the Commission.

1. The Commission of Guarantees for the Donation and Use of Cells and Human Tissue is created, as the collegiate body, attached to the Institute of Health Carlos III, of a permanent and consultative nature, directed to advise and guide on the research and experimentation with biological samples of human embryonic nature, and contribute to the updating and dissemination of scientific and technical knowledge in this field.

2. The approved commissions to be established in the Autonomous Communities will have the consideration of support commissions and reference of the Commission of Guarantees for the Donation and Use of Cells and Human Tissue, and will collaborate with it in the exercise of their functions.

Article 38. Functions of the Commission.

1. The Commission shall have the following tasks assigned:

(a) Ensure the scientific, ethical and legal guarantees that are required in connection with the investigations referred to in Article 35 and annually assess their results.

b) Issue, at the request of the State and Autonomous Community health authorities, reports on biomedical research with cells and tissues of human embryonic origin and on their clinical applications in the field of regenerative medicine.

c) Issue a mandatory report on research projects that require the entry and/or exit of embryonic material. In the case of research projects with embryonic stem cell lines from countries outside the European Union, the Commission shall only issue its report when the project incorporates the documentation certifying the origin, the procedures and guarantees for the procurement and treatment of stem cell lines and the rules of the country of origin governing this matter.

2. The Commission shall issue the mandatory report on the research projects received within the maximum period of three months.

Article 39. Composition of the Commission.

1. The Commission shall consist of 12 members. All of them will be specialists of recognized prestige in research in cell therapy or regenerative medicine, in bioethics and in law related to biomedical subjects.

2. The members of the Commission shall act at all times with criteria of independence and impartiality.

3. Its members shall be appointed by the Minister for Health and Consumer Affairs for three-year periods, with the following distribution:

(a) Six representatives appointed by the Interterritorial Council of the National Health System on the proposal of the autonomous communities.

b) Six representatives of the General Administration of the State, two by the Ministry of Health and Consumer Affairs, two by the Ministry of Justice and two by the Ministry of Education and Science.

4. The President of the Commission shall be appointed from among its members by the Minister for Health and Consumer Affairs.

5. The Secretary of the Commission shall be an official with the rank of Deputy Director General of the Carlos III Health Institute, who will act with voice and without a vote.

6. The members of the Commission shall have access to the precise information on research projects with cells and tissues referred to in this Title, on the National Register of Activity and Results of the Centres and Services of Assisted reproduction referred to in Law 14/2006 of 26 May on assisted human reproduction techniques and on the National Registry of Cell Lines.

CHAPTER IV

On the promotion and coordination of research with cells and tissues of human embryonic origin

Article 40. Promotion and coordination.

1. The promotion and coordination of research with biological samples of an embryonic nature will be the responsibility of the Ministry of Health and Consumer Affairs, through the Carlos III Health Institute, without prejudice to the powers that may be correspond to the Autonomous Communities.

2. The research projects to be informed by the Commission of Guarantees for the Donation and Use of Cells and Human Tissue will be referred to it by the competent authority, through the Institute of Health Carlos III, by the the procedure to be regulated.

Article 41. Project Log.

The Carlos III Health Institute will be responsible for the maintenance of the research project record, the data of which will be based on those provided by the competent authorities to authorize the projects, and will have up-to-date information on the registration of preembryos, oocytes and cell lines available in the in vitro fertilization centers, in the National Donors Registry and in the National Cell Lines Bank.

That record will include, at least:

(a) The identifying data of the centre where the project will be carried out and of the research team responsible for its implementation.

b) The documentation provided by the principal investigator in which the objectives, protocols to be used and the expected results of the project are set out.

c) The report of the Commission on Guarantees for the Donation and Use of Cells and Human Tissue.

d) The certification of the authorization to perform the research granted by the authority to which it corresponds.

e) To the completion of the authorized investigation, an evaluation report from the Commission on Guarantees for the Donation and Use of Cells and Human Tissue.

Article 42. The National Bank of Cell Lines.

1. The National Bank of Cellular Lines will have a network structure, with a central node in charge of coordination, and will be attached to the Carlos III Health Institute.

2. The National Bank of Cellular Lines will promote the quality and safety of the procedures on which it exercises its competence, will maintain the confidentiality of the data and other requirements regarding the actions it carries out, according to the provisions of Law 14/2006 of 26 May on techniques for assisted human reproduction, and on the Organic Law 15/1999 of 13 December on the Protection of Personal Data, and will provide in their actions the precautionary principles, proportionality and non-profit.

3. The Technical Commission of the National Bank of Cellular Lines, whose composition and functions will be determined by order of the Minister of Health and Consumer Affairs, will ensure that access to the cell lines for the execution of research projects carry out within the existing scientific, ethical and legal principles and must have up-to-date information on the registration of embryos and cell lines available in the in vitro fertilisation centres and in the line banks cell.

Article 43. Use of cell lines.

The use of cell lines or biological samples resulting from the investigations referred to in this Title shall be governed by the provisions of this Law and, where applicable, in the regulations on clinical trials and on clinical use of cells and tissues.

TITLE V

Genetic analysis, biological samples, and biobanks

CHAPTER I

General character provisions

Article 44. Object.

This title is intended to:

1. Set requirements to be met by institutions and individuals who perform genetic analysis and treat or store genetic data of a personal nature and biological samples.

2. Vellar for the correct use of biological samples for biomedical research.

3. Set the requirements that biobanks must meet for their creation and operation.

4. To ensure gratuitousness throughout the process of donation, disposal, storage and use of biological samples for both source and depositors, without prejudice to the compensation of costs.

Article 45. Specific guiding principles.

In addition to the guarantees provided for in Title I of this Law, the following principles shall apply:

(a) Accessibility and equity: equality in access to genetic analysis must be ensured without economic considerations and without prior requirements regarding possible personal choices.

b) Data protection: the right to privacy and respect for the will of the subject in the field of information, as well as the confidentiality of genetic data of a personal nature, shall be guaranteed.

c) Gratuity: the entire process of donation, cession, storage and use of biological samples for both the source and the depositors must be devoid of purpose or profit. Genetic data of a personal nature may not be used for commercial purposes.

(d) Consent: the written consent of the source or its legal representatives for the processing of samples for the purpose of research or genetic data of a character must be obtained in advance personnel.

e) Quality of data: data obtained from genetic analysis may not be processed or transferred for purposes other than those provided for in this Law.

CHAPTER II

Genetic analysis and treatment of genetic data of a personal nature

Article 46. Indication of genetic analysis.

In the terms provided for in Article 1.2, the genetic analysis shall be carried out for the identification of the state of the affected, unaffected or carrier of a genetic variant which may predispose to the development of a specific disease of an individual, or condition their response to a particular treatment.

Article 47. Information prior to the carrying out of genetic analysis for research purposes in the field of health.

Without prejudice to the provisions of the personal data protection legislation, before the subject gives consent in accordance with the terms set out in Article 48, he/she shall receive the following information by writing:

1. The Purpose of the genetic analysis for which you consent.

2. The location of the analysis and destination of the biological sample at the end of the sample, either the dissociation of the identification data of the sample, its destruction, or other destinations, for which the consent of the source subject in the terms provided for in this Law.

3. º Persons who will have access to the results of the analyses when those are not going to be subjected to dissociation or anonymisation procedures.

4. Warning on the possibility of unexpected discoveries and their possible transcendence for the subject, as well as on the ability of the subject to take a position in relation to receiving their communication.

5. " Warning of the implication that may have for your family the information that may be obtained and the convenience that the same, if any, transmit this information to those of you.

6. Pledge to provide genetic advice, once the results of the analysis have been obtained and evaluated.

Article 48. Consent.

1. Express and specific written consent will be required for the conduct of a genetic analysis.

2. In the field of health, samples of deceased persons may be obtained and analysed, provided that they may be of interest to the protection of health, unless the deceased has expressly prohibited him in life and is thus accredited. To this end, the documents of previous instructions and, failing that, the criterion of the closest relatives of the deceased will be consulted.

The access of biological family members to information derived from the genetic analysis of the deceased will be limited to the genetic data relevant to the protection of the health of those.

3. In order to access a genetic screening, the interested party's explicit and written consent will be required. The Research Ethics Committee shall determine the cases in which the consent may be expressed verbally. In any case, where the screening includes non-treatable diseases or the benefits are scarce or uncertain, consent will always be obtained in writing.

4. Performing genetic analyses on in vivo preembryos and on embryos and fetuses in the womb will require written consent from the pregnant woman.

The genetic analysis of a non-transferred in vitro preembryo will be governed by the law on assisted human reproduction techniques.

Article 49. Right to information and right not to be informed.

1. The source shall be informed of the genetic data of a personal nature which is obtained from the genetic analysis according to the terms in which it expressed its will, without prejudice to the right of access recognised in the legislation on data protection. of a personal nature, which may result in the revocation of the previous free-will demonstration granted.

2. Where the source has exercised the right not to be informed of the results of a genetic analysis, only the information necessary for the monitoring of the treatment prescribed by the physician and accepted by the patient shall be provided. Where such information is necessary to avoid serious harm to the health of their biological family members, the persons concerned or their legally authorised representative may be informed. In any event, the communication shall be limited exclusively to the data necessary for these purposes.

Article 50. Access to genetic data by healthcare personnel.

1. Healthcare professionals in the centre or establishment where the patient's medical history is preserved shall have access to the data contained therein as relevant to the care provided to the patient, without prejudice to the reservation and confidentiality duties to which they are subject.

2. Genetic data of a personal nature may only be used for epidemiological, public health, research or teaching purposes where the person concerned has expressly given his consent, or where such data has been previously anonymized.

3. In exceptional cases and in the general public health interest, the competent authority, after a favourable report by the data protection authority, may authorise the use of coded genetic data, provided that they cannot be relate to or associate with the source subject from third parties.

Article 51. Duty of confidentiality and right to the protection of genetic data.

1. Personnel who access genetic data in the performance of their duties shall be subject to the duty of secrecy on a permanent basis. Only with the express and written consent of the person from whom the genetic data of a personal character may be disclosed may be disclosed to third parties.

If it is not possible to publish the results of an investigation without identifying the source subjects, such results may only be published with their consent.

2. In the case of genetic analysis to several members of a family the results will be archived and communicated to each one of them individually. In the case of disabled persons or minors, their guardians or legal representatives will be informed.

Article 52. Data retention.

1. Genetic data of a personal nature shall be kept for a minimum period of five years from the date on which they were obtained, after which the data subject may request cancellation.

2. If the data subject's request is not made, the data shall be kept for the period necessary to preserve the health of the person from whom it comes or from third parties related to it.

3. Outside of these assumptions, data may only be retained for research purposes in an anonymised manner, without the identification of the source being possible.

Article 53. Genetic analysis in preembryos, embryos, or fetuses.

The results of genetic analyses performed on embryonic or fetal material will be subject to the principles of data protection and confidentiality established in this Law. The same criterion shall govern in relation to any other biological sample which may contain genetic information of the person who provided his or her own biological material for the obtention of that biological material.

Article 54. Genetic screening.

1. Genetic screening shall be aimed at detecting a serious disease or risk for health in the individual participant or in his or her offspring, in order to treat the disease early or to provide access to preventive measures.

2. The health authorities shall determine, on the basis of objective criteria, the relevance of genetic screening for disease prevention or treatment. They shall also ensure that universal and equitable access to the population for which screening is indicated is ensured, by the organisation and planning of the programme, as well as by the quality of screening tests, Second-level diagnostic and preventive and therapeutic benefits to be offered.

3. For the screening, the psycho-social aspects and their integration into the health system will be taken into account. In addition, the specific screening programme concerned shall be evaluated by the ethics committee of the centre where it is carried out.

4. Appropriate procedures shall be established for the continuous monitoring and evaluation of the programme.

5. Participation in a genetic screening shall be offered to all members of the population to whom it is addressed, for which the prior written consent of each subject affected shall be required in the terms provided for in Articles 4 and 48.3.

6. Information prior to such consent shall be made in writing and shall relate to:

a) The characteristics and objectives that are pursued with screening.

b) The voluntary nature of participation.

c) The validity and reliability of screening tests and second-level diagnostic tests.

d) The ability to obtain false positives and, consequently, the need to confirm or discard the diagnosis.

e) The periods of time that elapse between the different stages of the screening process.

f) The existing possibilities of treatment and prevention of the disease once diagnosed.

g) Inconveniences, risks and adverse events that may arise from the diagnostic process, including those associated with sampling and the therapeutic or preventive measures offered by the program.

7. The system established by this Law for genetic analysis shall apply to the tests used for genetic screening.

Article 55. Genetic advice.

1. Where a genetic analysis is carried out for health purposes, the person concerned must be assured of appropriate genetic advice, in the manner in which he is regulated, in accordance with the person's discretion. interested.

2. The professional who carries out or coordinates the genetic advice should provide adequate information and advice concerning both the significance of the resulting genetic diagnosis and the possible alternatives for which the genetic test may be used. subject to the view of that.

Article 56. Quality requirements.

The whole process of genetic advice and genetic testing for health purposes must be carried out by qualified personnel and must be carried out in accredited centres that meet the quality requirements that Regulation is established for this purpose.

Article 57. Accreditation of genetic analysis centers.

The competent authority or state authority shall credit institutions, public or private, which may carry out genetic analysis and which, in any event, shall comply with the provisions of Articles 46 to 57 of this Law.

CHAPTER III

Using human biological samples for biomedical research purposes

Article 58. Obtaining the samples.

1. The obtention of biological samples for biomedical research purposes may be carried out only where the written consent of the source has been obtained in advance and after information of the consequences and the risks that may arise. to obtain for your health. Such consent shall be revocable.

2. The consent of the source shall always be necessary where biological samples which have been obtained for a different purpose are intended to be used for biomedical research purposes, whether or not to be anonymised.

However, in exceptional cases, coded or identified samples for biomedical research purposes may be processed without the consent of the source, where the obtaining of such consent is not possible or represents an unreasonable effort within the meaning of Article 3 (i) of this Law. In such cases, the favourable opinion of the Research Ethics Committee shall be required, which shall take into account at least the following requirements:

a) That is an investigation of general interest.

b) That the investigation be carried out by the same institution that requested consent to obtain the samples.

c) That the investigation be less effective or not possible without the identifying data of the source subject.

d) That there is no express objection to it.

e) Ensuring the confidentiality of personal data.

3. Without prejudice to Article 7, an economic compensation may be fixed for the physical inconvenience, costs and other disadvantages that may arise from the sampling.

4. When, for health reasons, the source or family needs it, they may make use of the samples, provided they are available and are not anonymized.

5. The collection of biological samples of minors and disabled persons for biomedical research purposes shall be subject to the following conditions:

(a) Take the necessary steps to ensure that the risk of intervention is minimal for the source.

b) That research may obtain relevant knowledge about the disease or situation under investigation, which is of vital importance for understanding, palliating or curing it.

c) That this knowledge cannot be otherwise obtained.

d) That the legal representatives of the minor or the disabled person have the authorization or that, where appropriate, there are guarantees regarding the correct consent of the source subjects.

6. In genetic diversity studies, local and ethnic traditions will always be respected, avoiding in any case practices of stigmatization and discrimination.

Article 59. Information prior to the use of the biological sample.

1. Without prejudice to the provisions of the legislation on the protection of personal data, and in particular Article 45 of this Law, before giving consent for the use of a biological sample for research purposes The source will receive the following information in writing:

a) Finality of the research or line of research for which you consent.

b) Expected Benefits.

c) Possible drawbacks linked to the donation and procurement of the sample, including the possibility of being contacted later in order to collect new data or obtain other samples.

d) Identity of the person responsible for the investigation.

(e) the right of withdrawal of consent and its effects, including the possibility of the destruction or anonymisation of the sample and of the fact that such effects will not be extended to the data resulting from the investigations already being carried out have been carried out.

f) Place of analysis and destination of the sample at the end of the investigation: dissociation, destruction, or other investigations, and which, if necessary, will in turn lead to the fulfilment of the requirements set out in the This Law. In the event that these extremes are not known at the moment, the commitment to report on this will be established as soon as it is known.

g) Right to know the genetic data obtained from the analysis of the donated samples.

h) A guarantee of confidentiality of the information obtained, indicating the identity of the persons who will have access to the personal data of the source subject.

i) Warning of the possibility of obtaining information regarding their health derived from genetic analyses performed on their biological sample, as well as their ability to take a position in relation to their communication.

j) Warning of the implication of the information that may be obtained for your family members and the desirability that the same, if any, transmit such information to those of you.

k) Indication of the possibility of contacting him/her, for which information on how to do so may be requested.

2. In the case of use of samples to be anonymized, the source shall receive the information contained in paragraphs (a), (b), (c) and (d) of this Article.

Article 60. Consent to the use of the biological sample.

1. Consent to the use of the biological sample shall be granted either in the act of obtaining the sample, or subsequently, in a specific way for a specific investigation.

2. The specific consent may provide for the use of the sample for other lines of investigation related to the initially proposed, including those made by third parties. If this is not the case, the source will be asked to grant, if deemed appropriate, a new consent.

3. Consent may be revoked, in whole or for certain purposes, at any time. Where the revocation relates to any use of the sample, it shall be immediately destroyed, without prejudice to the preservation of the data resulting from the investigations that have been carried out on a prior basis.

Article 61. Preservation and destruction of samples.

1. In the case where the sample is preserved, the source shall be informed in writing of the conservation conditions, objectives, future uses, disposal to third parties and conditions to be able to withdraw them or to request their destruction. However, biological samples used in biomedical research shall be kept only as long as they are necessary for the purposes which justified their collection, unless the source has granted their explicit consent for other purposes. Subsequent uses.

2. The above paragraph is applicable as long as the identification data of the sample has not been subject to its anonymisation in accordance with the provisions of this Law.

Article 62. Report of the Research Ethics Committee.

It will be necessary, in any case, the favorable report of the Research Ethics Committee for the center for the collection and use of biological samples for biomedical research and for biodiversity studies, in where the use of biological samples from deceased persons is envisaged or where the incorporation of a biological sample is intended for a line of research not related to that for which it was obtained initially consent.

CHAPTER IV

Biobanks

Article 63. Scientific interest.

Authorization to create a biobank will require your organization, objectives, and available means to justify your biomedical interest.

Article 64. Authorization.

1. It shall be the responsibility of the Minister for Health and Consumer Affairs to set up national biological sample banks which are deemed appropriate due to the general interest.

2. The approval of the competent authority of the Autonomous Community concerned shall be required for the establishment of other biobanks.

Article 65. Entitlement.

1. The natural or legal person, public or private, holding the ownership of a biobank shall be responsible for it.

2. If the change of ownership of the person responsible for the biobank occurred, or the modification or extension of the objectives of the biobank, such a circumstance shall be communicated to the competent authority, which shall, where appropriate, grant a new authorisation.

Article 66. Organization of the biobank.

1. The biobank must have a scientific director, a responsible for the file, and will be attached to the external committees, one of them scientific and one of ethics, respectively, that will assist the director of the biobank in his functions.

2. The director of the biobank shall have the following obligations:

a) Velar for compliance with current legislation.

b) Maintain a log of biobank activities.

c) Ensure the quality, safety and traceability of stored biological data and samples and the procedures associated with the operation of the biobank.

d) Develop an annual activity report, which they will make available to the authority that gave the authorization for the creation of the biobank.

e) Understanding queries or claims that can be addressed to the biobank.

f) Develop the biobank good practice document.

g) Elaborate the descriptive memory that collects the characteristics of the collections, the inclusion criteria and the purposes for which the collection is constituted, the way in which the historical collection has been collected, and the information that can be associated with the samples.

3. The person responsible for the file will address the requests for the exercise of the rights of access, rectification, cancellation or opposition made by the source, in accordance with the provisions of the current regulations on data protection personal character.

Article 67. National Register of Biobanks.

1. Once the biobank has been established in accordance with the above procedure, the competent authority will register in the National Register of Biobanks for Biomedical Research, under the dependency of the Carlos III Health Institute. You will have to register before the Spanish Data Protection Agency, in accordance with the current legislation. The data in this Register shall be based on those provided by the competent authorities for the authorisation of biobanks.

2. Any public or private person or establishment who has one or more ordered collections of human samples or biological material from identified or identifiable persons shall also register them in the National Register of Biobanks. Such a requirement shall be independent of its registration in the registers of other institutions due to its special nature or purpose.

3. The Ministry of Health and Consumer Affairs will certify the nature and scope of the collection once registered.

4. Collections maintained by natural persons for exclusively personal uses, or samples, even if ordered as a collection, which have been obtained for the purpose of carrying out the tests, shall not be subject to the registration indicated. relevant for diagnostic purposes and, where appropriate, for the treatment of the source subject, and which are not kept in storage for a period of time exceeding these objectives.

Article 68. Inspections and control measures.

The competent authority shall carry out periodic inspections to ensure that biobanks comply with the conditions of installation, organisation and operation with which they were authorised.

Article 69. Sample collection and disposal.

1. The collection of samples shall be carried out in accordance with the provisions of Chapter III of this Title.

2. Samples stored in the biobank shall be transferred to a third party free of charge for the purposes of biomedical research. Only samples shall be submitted for applications from research projects which have been scientifically approved. The application shall contain information about the project to be developed, the explicit commitment of the applicant centre and/or the researchers involved in the project of not using the requested material for a different use than the one mentioned therein. It will take the go-ahead from the bank's scientific and ethical committees.

3. The costs of obtaining, maintaining, handling, shipping and other similar costs related to the samples may be passed on to each sample. In any case the amount of sample ceded will be the minimum necessary for the project to be carried out.

4. The procurement, transport, storage, handling and dispatch of samples shall be carried out under biosecurity conditions, in accordance with applicable legislation.

5. The total or partial refusal by the biobank of the delivery of the samples to be requested for the purposes of biomedical research will require a reasoned decision of the person responsible, for which the respective previous reports will have of the Scientific Director and of the Scientific and Ethical Committees referred to in Article 66.1.

6. The transfer of samples may be accompanied by the associated clinical information, in which case the data shall be protected in accordance with the provisions of the Law on Patient Autonomy and the Law on the Protection of Personal Data.

Article 70. Rights of source subjects.

1. For biological samples deposited in biobanks, the provisions of Chapter III of this Title relating to obtaining, prior information, consent, confidentiality, transfer, data retention and samples, access to data and the right not to be informed.

2. By way of derogation from the above paragraph, biological samples which are incorporated into biobanks may be used for any biomedical research, in the terms prescribed by this Law, provided that the source or, where appropriate, the source their legal representatives have given their consent in these terms.

Article 71. Closure or closure of the biobank.

1. The competent authority may decide, on its own initiative or at the request of a party and by means of a reasoned decision, to close or close the biobank in cases where the conditions for its creation, organisation and operation are not met. established in this Law, or when its holder manifests the will not to continue with its activity.

2. This resolution shall also indicate the destination of the samples stored in the biobank to be closed or closed.

TITLE VI

Breaches, penalties and compensation for damages

Article 72. General provisions.

1. The infringements established by this Law concerning the collection and use of human tissues and cells, the use of invasive procedures in biomedical research, as well as genetic data of a personal nature, will be the subject of the appropriate administrative penalties, subject to the instruction of the appropriate file, without prejudice to the civil, criminal or other responsibilities that may arise.

2. The sanctioning power regulated in this Law shall be exercised, as not provided for in this Law, in accordance with the provisions of Law 30/1992, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, in Law 14/1986, of 25 April, General of Health and in Organic Law 15/1999, of 13 December, of Protection of Personal Data.

3. Where, in the case of the Administration, the offence may constitute a crime or a fault, the administrative body shall transfer the Prosecutor's Office, refraining from pursuing the sanctioning procedure as long as the judicial authority does not has been pronounced.

The criminal sanction will exclude the imposition of administrative sanctions when the penalty is imposed by the same facts and according to the same protected public interests, although the other responsibilities that are From other events or concurrent violations.

If the existence of a crime has not been estimated, the administration will continue the sanctioning file based on the facts that the courts have considered to be proven.

4. The administrative measures that would have been taken to safeguard the right to the protection of the health and safety of persons shall be maintained as long as the judicial authority decides on them.

5. Very serious infringements will be prescribed at three years; the serious ones, at two years, and the mild ones, at six months. Penalties imposed for very serious offences shall be imposed at three years of age; those imposed for serious misconduct, at two years of age, and those imposed for minor offences, per year.

Article 73. Responsibilities.

1. The author will be responsible for the various infringements.

2. Where the fulfilment of the obligations laid down in this Law corresponds to a number of persons together, they shall respond in solidarity in accordance with the provisions of Article 130.3 of Law No 30/1992 of 26 November 1992 on Legal Conditions of the General Administration and the Common Administrative Procedure. The same rule shall apply to the directors of the centres or services for the failure to comply with the obligations of the biomedical professionals who are dependent on them.

Article 74. Violations.

1. Infringements shall be classified as minor, serious, or very serious, taking into account the lesivity of the event, the amount of the possible benefit obtained, the health and social change produced and their degree of intentionality.

2. In addition to those mentioned in the General Health Law, the Law on the Protection of Personal Data, the Law on Assisted Human Reproduction Techniques, the Basic Law on the Autonomy of the Patient and Rights and Obligations in the subject of clinical documentation and in those other rules established by the Autonomous Communities, for the purposes of this Law are considered to be minor, serious and very serious infractions, the following:

A) They are minor infractions:

Those who behave in the breach of any obligation or the violation of any prohibition established in this Law, provided that the criteria referred to in this article do not carry out their qualification as serious or very serious infringements.

B) These are serious violations:

(a) The failure to comply with the requirements, conditions, requirements and prior authorizations established in this Law for the operation of the records provided for in this Law.

b) The omission of data, consents and references required by this Act.

(c) The absence of data provision to the health authority that corresponds to the functioning of the records provided for in this Law, of the corresponding data.

d) The breakdown of the conditions of confidentiality of donor data established in this Law.

e) Non-compliance with the gratuitousness of the donation of preembryos, embryos and fetuses, in the terms established in the Law.

f) Non-compliance with the standards and guarantees established for the transfer of cells and tissues of human embryonic origin between countries.

C) These are very serious violations:

a) The realization of any intervention directed to the introduction of a modification in the genome of the offspring.

b) Maintain in vitro development of the preembryos beyond the limit of 14 days following the fertilisation of the ovocyte, discounting from that time the one that may have been cryopconserved.

c) Maintain live embryos or fetuses outside the uterus with any purpose other than procreation.

d) The removal of cells or tissues from embryos or foetuses in development, from the placenta or from their wrappers for purposes other than diagnostic or therapeutic in the interest of those, except in the cases provided for in the Law 14/2006, of May 26, on assisted human reproduction techniques.

e) Failure to comply with the provisions of Article 33.

f) The production of interspecific hybrids using human genetic material, except as provided for in the Law on assisted human reproduction techniques.

g) The failure to comply with the requirements, conditions, requirements or prior authorizations established in this Law for the collection and use of cells and tissues of human embryonic origin or other functionally similar.

Article 75. Penalties.

1. The minor offences against what is foreseen in this Law will be sanctioned with a fine of up to 600 euros, the serious ones with fine from 601 euros up to 10,000 euros, and the very serious ones from 10,001 euros to 1,000,000 euros.

2. The amount of the penalty imposed, within the limits indicated, shall be graduated taking into account the risk generated, the social impact of the offence, the benefit which the offender has reported to the offender and the prior commission of one or more violations against this Law.

3. In any event, where the amount of the fine is less than the benefit obtained by the commission of the infringement, the penalty shall be increased to twice the amount in which the infringer has benefited.

4. If the same event is a constitutive of two or more offences defined in this or other Laws, only the one that carries the greatest sanction shall be taken into consideration.

5. The amounts of the fines shall be reviewed and regularly updated by the Government, taking into account the variation in the consumer price indices.

6. Without prejudice to the penalties provided for in this Article, serious or very serious infringements shall lead to the revocation of the authorisation granted for the investigation or activity concerned.

Also, in particularly serious cases, the exclusion of authorisation from any of the activities regulated in this Law may be agreed for a period of one to five years. For the imposition of this measure, account shall be taken of the risk generated, the social impact of the infringement, the benefit that the offender has reported to the offender and the prior commission of one or more violations against this Law.

Article 76.

The competent bodies shall exercise control and inspection functions, either on their own initiative or at the request of a party, as well as the instruction and resolution of sanctioning files.

TITLE VII

The Bioethics Committee of Spain

Article 77. Nature of the Committee.

The Bioethics Committee of Spain is created, as a collegiate, independent and consultative body, on matters related to the ethical and social implications of Biomedicine and Health Sciences.

It will be attached to the Ministry of Health and Consumer Affairs, which will designate its headquarters.

Article 78. Functions.

1. They are the functions of the Bioethics Committee of Spain:

a) Issue reports, proposals, and recommendations for state and regional public authorities on issues with relevant ethical implications.

b) Issue reports, proposals, and recommendations on matters related to the ethical and social implications of Biomedicine and Health Sciences that the Committee considers relevant.

c) Establish the general principles for the development of codes of good scientific research practices, which will be developed by the Research Ethics Committees.

d) Represent Spain in the forums and supranational and international organizations involved in the Bioethics.

e) Develop an annual activity memory.

f) Cuestuas others that entrusts them with the law of development of this Law.

2. The reports, proposals, recommendations and other documents prepared by the Bioethics Committee of Spain may be published for general knowledge and dissemination, with full respect for the constitutionally recognized fundamental rights.

3. The Bioethics Committee of Spain will collaborate with other state and regional committees that have advisory functions on the ethical and social implications of Biomedicine and Health Sciences and will encourage communication between them, without prejudice of their respective competences.

Article 79. Composition and designation of its members.

1. The Committee shall be composed of a maximum of 12 members, chosen from accredited accredited persons from the scientific, legal and bioethical world. In its composition, the balanced presence of the different disciplines involved in the bioethical reflections should be sought.

2. The members of the Committee shall be appointed by the Minister for Health and Consumer Affairs as follows:

a) Six members, on a proposal from the autonomous communities, as agreed to this effect within the Interterritorial Council of the National Health System.

b) Six members proposed by the General Administration of the State in the following proportion:

1. º One by the Ministry of Justice.

2. º One by the Ministry of Education and Science.

3. º One by the Ministry of Industry, Tourism and Commerce.

4. º Three by the Ministry of Health and Consumer Affairs.

3. The Chairman of the Committee shall be appointed from among its members by the Minister for Health and Consumer Affairs.

4. The Secretary of the Committee shall be an official with the rank of Deputy Director General of the Carlos III Health Institute, who will act with voice and without a vote.

Article 80. Term of office and exercise of office.

1. The members of the Committee shall have a four-year term of office renewable for one time, unless they replace another previously appointed member before the expiry of the deadline, in which case their term of office shall be for the time to be completed. four years from the appointment of the original member, without prejudice to the possibility of renewal.

2. The renewal of the members shall be carried out by halves every two years, except the first, which shall be by lot.

3. The members of the Committee shall cease for the following

:

a) Expiration of your command.

(b) Renunciation, which shall have effect by mere notification to the Minister of Health and Consumer Affairs.

(c) Separation agreed by the Minister for Health and Consumer Affairs, after hearing the person concerned, for permanent incapacity for the exercise of his duties, serious breach of his obligations, incompatibility of Prosecution for criminal offence. For these purposes, the opening order of the oral judgment shall be treated as the order of processing.

4. The members of the Committee shall act independently of the authorities who have proposed or appointed them and may not belong to the governing bodies of the State Administration, Autonomous Communities or local corporations, as well as to the Courts. General or Legislative Assemblies of the Autonomous Communities.

Article 81. Operation.

1. The Committee shall operate in plenary and in the Standing Committee. The composition and functions of both bodies shall be determined by regulation.

2. The functioning of the plenary session and the Standing Committee shall be developed in an internal regulation, which shall be adopted by the Committee in plenary.

3. This Regulation shall include at least the following aspects

a) Frequency of their meetings, which at least will be quarterly.

b) deliberative and decision-making procedures.

c) Extension and limits of the duty of confidentiality of its members.

d) Members ' independence and conflicts of interest.

e) Procedure of election of the President.

TITLE VIII

Promotion and coordination of biomedical research in the National Health System

Article 82. Health Research Sector Initiative.

1. In the preparation of the Sectoral Health Research Initiative, integrated in the Scientific Research, Development and Technological Innovation Plan, the Ministry of Health and Consumer Affairs will take into account the proposals presented by the Autonomous communities for the establishment of priority areas, in line with the health needs of the population and the objectives of improvement in health and public health services.

In the exercise of their competencies, the autonomous communities will be able to establish their own biomedical research plans and will have, through the Sectoral Initiative of Health Research, a frame of reference state for the best use of existing resources and the strategic adaptation of research to national health action plans.

2. The elaboration of the Sectoral Health Research Initiative will take into account the human, material and budgetary resources needed to ensure the regular financing of the promotion and development of scientific research. and quality technique in biomedicine.

Article 83. Promotion of the research activity of the National Health System.

1. Research activities will have to be promoted throughout the health system as a key element in the health system's progress.

2. The Carlos III Health Institute will contribute to the research of the National Health System in the terms provided for in Article 48 of Law 16/2003, of 28 May, of Cohesion and Quality of the National Health System, and promote and coordinate research in biomedicine through the implementation of basic and applied research, the impetus of epidemiological and public health research, scientific and technical accreditation and foresight, health control, Scientific-technical advice and health education and training in biomedicine.

3. In the field of regulation on research collected in Chapter IV of Law 16/2003, of 28 May, of cohesion and quality of the National Health System, the Ministry of Health and Consumer Affairs and the Autonomous Communities will promote the intervention of the hospitals as the backbone of the research in cooperative and network form. Primary care facilities may be involved in research networks.

4. In the execution of biomedical research and in the health sciences of the National Health System, public research agencies that are dependent on the General Administration of the State and the Autonomous Communities may participate, whether or not belonging to the National Health System, universities and public or private non-profit companies and institutions engaged in research and technological development activities.

Programs included in biomedical research may also be executed in collaboration with foreign institutions of an international nature.

5. The bodies, undertakings and institutions referred to in the preceding paragraph may contract to assist in the implementation of the research and technological development activities under the Sectoral Research Initiative, scientific staff, experts in technological development and other specialists related to R & D activities, under the conditions laid down in Article 17 of Law 13/1986 of 14 April, for the Promotion and General Coordination of Research Scientific and Technical.

Article 84. Promotion and coordination of the research training of the staff of the National Health System.

1. Public administrations will support training in the field of biomedical research through the development of the measures outlined in this Law, the implementation of grant and aid programmes and the improvement of their working conditions.

2. The National Council of Specialties in Health Sciences will promote research and technological and methodological innovation in specialized healthcare training.

Article 85. Research career in the centers of the National Health System.

1. Public administrations shall, in the framework of the planning of their human resources, encourage the incorporation of the health services of research staff under statutory arrangements.

In the case of centers covered by the new forms of management of the National Health System of Law 15/1997, of April 25, the incorporation of research personnel will be carried out in the appropriate legal system.

In both scenarios such incorporation will be performed through the legally established procedures.

2. The centres of the National Health System may recruit temporary staff engaged in research activities in accordance with the following conditions:

(a) Training researchers, who will be licensed or engineers once the Diploma of Advanced Studies or administrative document that replaces it in accordance with the new structure of teaching adapted to the Space European Higher Education, for a maximum period of two years, which must be the following to obtain such a diploma, in accordance with Royal Decree 63/2006 of 27 January, approving the statute of the investigating staff in training.

(b) Further training researchers, who shall be doctors or specialists who have undergone specialised health training and who shall be recruited for research under the conditions laid down in Article 17.1.b) of the Law on the general coordination of scientific and technical research.

3. The selection and recruitment of such staff shall be subject to the principles of public concurrence, merit and capacity and independent scientific assessment of the scientific community.

4. The activities carried out in accordance with the provisions of paragraph 2 of this article will be included in the merit scales for the obtaining of seats of optional staff in the health institutions of the National Health System. They will also be taken into account in the professional promotion of the professionals of the National Health System who develop care activities.

5. Public administrations, in the field of their competences, may include research activity as part of the system for the recognition of the professional development of statutory staff, in accordance with the provisions of Article 37 of the Treaty. Law 44/2003 of 21 November 2003 for the management of health professions.

6. In the field of the respective health services, the measures necessary to facilitate the compatibility of the care and the scientific activity in the health professions will be arbitrated, in accordance with Law 53/1984, of December 26, Incompatibilities of staff at the service of public administrations.

Article 86. Mobility of research staff.

1. Mobility and the exchange of researchers linked to the health research of different centres within the national framework and the European Research Area and the reciprocal cooperation agreements with other States shall be encouraged.

Officials belonging to research bodies or scales may be authorized to carry out work related to scientific and technological research outside the organic field to which they are attached, by means of mobility mechanisms provided for in public service legislation.

2. Provided that a technological base company is created from patents or results generated by research projects financed in whole or in part with public funds and carried out in research centres, officials or Statutory staff who base their participation on the above projects may apply for authorisation to join such a company, by means of temporary leave.

The government will regulate the conditions and the procedure for granting such a surplus which, in any event, can only be granted for a maximum limit of five years. During this period, the surplus shall be entitled to the reserve of the job and to its calculation for the purposes of seniority. If, prior to the last month preceding the end of the period for which the surplus was granted, the official or staff member did not apply for re-entry into the active service, he shall be declared ex officio on leave of absence. voluntary for particular interest.

Article 87. Temporary membership of specialists.

The Ministry of Health and Consumer Affairs, after authorization from the relevant body, may be assigned temporarily, in full or in part, scientific staff, experts in clinical research and technological development, to provide services in ministerial departments, autonomous communities, universities, public research bodies and public entities. Such membership shall be articulated in accordance with the rules of the legal regime of the official or labour staff applicable to it, in each case.

The part-time subscription of the staff mentioned above will be compatible with the performance, equally in part-time benefit, of the job that you are occupying. They may also hire, for time not exceeding the duration of the Sectoral Health Research Initiative, any type of staff not assigned to the public sector, as laid down in Article 15.1 (a) of the Staff Regulations. the Workers, and in accordance with the provisions of the corresponding Public Employment Offerings.

Article 88. Research institutes and networks.

The National Health System will collaborate with other institutions and organizations involved in research for the joint use of scientific infrastructures and the development of research projects. To this end, the configuration of biomedical research institutes within the centers of the National Health System will be promoted through the association of research groups.

For the purposes of participation in the calls of the Ministry of Health and Consumer Affairs, the research capacity of these institutes may be certified by the Ministry of Health and Consumer Affairs, at the Institute's proposal. of Health Carlos III or of the Autonomous Communities, by the procedure to be established regulentarily.

According to the provisions of Article 42.2 of Law 30/1992, of November 26, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, the time limit for resolution and notification in the the certification procedure referred to in this Article shall be 12 months.

Article 89. Cooperation between the public and private sectors.

1. In order to increase the involvement of the private sector in Biomedical Research and Health Sciences, procedures for the participation of private entities that develop research or development activities will be established. In the implementation of the research actions of the National Health System.

2. For the purpose of the objective of the first paragraph, the centers of the National Health System, the public institutions and public health sciences and the universities will be able to conclude agreements with entities. Private sector, which carry out scientific research and technological development activities. In these agreements, it will be possible to establish the possibility for the staff of these private entities to participate in the implementation of programs or research projects of the National Health System. In any event, this participation shall generate the right to access to the public service or to the service of the public administration by means of an employment or other relationship.

3. Public administrations will promote environments conducive to the development of private initiatives and encourage the creation of new business opportunities arising from the National Health System itself, including the formation of companies. Capital-risk capital-oriented investment in biomedical research.

4. In addition, measures will be taken to promote adequate returns to the National Health System, in order to focus on investments in the field of biomedical research.

Article 90. Funding.

1. For the financing of the actions referred to in the previous articles, the management of which corresponds to the Ministry of Health and Consumption, the financing instruments provided for in the National Plan of Scientific Research shall be used, Development and Technological Innovation. Such funding shall be borne by the budget items of this Ministry, without prejudice to existing co-financing arrangements or to be established in the future with public and private entities.

2. The financing of the actions mentioned in the previous article to be managed by the Ministry of Health and Consumer Affairs will be in line with the national R & D + i Plan, even if the funds come from legally fixed tariffs, and to budget items of the said ministerial department, without prejudice to the existence of co-financing agreements with public or private entities.

Additional disposition first. Use of human tissues and cells for therapeutic purposes.

The use for therapeutic purposes of any biological material of human origin referred to in this Law, shall be governed, as appropriate by Law 30/1979, of 27 October, on the extraction and transplantation of organs, the Law 14/2006 of 26 May on assisted human reproduction techniques and other provisions implementing them, without prejudice to the provisions of Title II of this Law in those cases where it is applicable.

Additional provision second. Promotion of biomedical research by the Carlos III Health Institute.

One. Instrumental means.

1. The Carlos III Health Institute shall have the consideration of means of its own instruments and technical service of the General Administration of the State and its bodies and entities governed by public law, in the matters that constitute its purposes, and shall carry out the work, services, studies, projects, technical assistance, works and how many actions are entrusted to it by those bodies in the form set out in this provision.

2. The amount to be paid for the works, services, studies, projects and other actions carried out through the Carlos III Health Institute will be determined by applying to the units executed the tariffs that have been fixed, according to the cost of the service, by resolution of the Minister of Health and Consumer Affairs at the proposal of the Directorate of the Health Institute Carlos III.

The compensation to be paid in cases where there is no fee will also be established by resolution of the Minister of Health and Consumer Affairs.

3. In the cases provided for in Article 17.1 of the Law on the Promotion and General Coordination of Scientific and Technical Research, classification as a contractor of the Carlos III Health Institute will not be required to be awarded contracts. with public administrations.

Two. Own research centres.

The Carlos III Health Institute will promote research in priority thematic areas by setting up research units with the legal form of foundation or any other appropriate to the nature of functions to be performed. These units shall have the character of their own centres.

The financial contributions granted globally to such centres for operation shall not be understood as falling within the scope of Law 38/2003 of 17 November, General Grants.

Three. Virtual research centers in the form of a network.

The Carlos III Health Institute will establish the mechanisms for the networks referred to in Article 51 of Law 16/2003 of 28 May to exceed the criteria of quality and suitability, after being properly evaluated, can be converted into virtual research centres in the form of a network, with its own legal personality.

Additional provision third. Post-graduate training in Health in the framework of the European Higher Education Area.

The National School of Health will be able to teach postgraduate courses in Health in the Framework of the European Higher Education Area.

First transient disposition. Commission for Monitoring and Control of Donation and Use of Cells and Human Tissue.

The Commission of Guarantees for the Donation and Use of Cells and Human Tissue will be created in accordance with Article 37 et seq. of this Law, it will assume its functions provided for in Article 38, ensuring compliance with the of the guarantees and requirements set out in Article 34 and 35 of this legal standard, the Commission for Monitoring and Control of Donation and Use of Cells and Human Tissue, referred to in Royal Decree 2132/2004 of 29 October, by the establishing the requirements and procedures for requesting the development of projects of research with stem cells obtained from leftover preembryos.

Second transient disposition. Samples previously stored.

Biological samples obtained prior to the entry into force of this Law may be treated for biomedical research purposes when the source has given their consent or when the samples have been previously anonymized. However, samples coded or identified for purposes of biomedical research may be processed without the consent of the source, where the obtaining of such consent represents an unreasonable effort in the sense indicated in paragraph (i) of Article 3 of this Law, or is not possible because the source is deceased or unlocatable. In such cases, the favourable opinion of the Research Ethics Committee shall be required, which shall take into account at least the following requirements:

a) That is an investigation of general interest.

b) That the investigation be less effective or not possible without the identifying data of the source subject.

c) That there is no express objection to it.

d) Ensuring the confidentiality of personal data.

Transitional provision third. Ethical Committees of Clinical Research.

The Ethical Committees of Clinical Research will cease to exist as soon as the Research Ethics Committees are established. Until such committees are constituted, the Ethical Committees of Clinical Research that are in operation in the centers that conduct biomedical research, will be able to assume the competences of those.

Single repeal provision. Regulatory repeal.

Law 42/1988 of 28 December 1988 on the donation and use of human embryos and foetuses or their cells, tissues or organs is hereby repealed, and any provisions which, whatever their rank, are contrary to the provisions of the in this Law. Article 45 (5) and (6) and Articles 46, 47 and 50 of Law 16/2003 of 28 May, of cohesion and quality of the National Health System, Title VII and Chapters II and III of Title VI of Law 14/1986 are hereby repealed. 25 April, General Health; the second provision of Law 14/2006 of 26 May on assisted human reproduction techniques; and Articles 10 and 11 of the Statute of the National Centre for Transplantation and Regenerative Medicine, adopted by Royal Decree 176/2004, of January 30.

Final disposition first. Competence title.

This Law is adopted pursuant to article 149.1.15. and 16. of the Spanish Constitution, which attributes to the State exclusive competence in the field of the promotion and general coordination of scientific and technical research and (a) the basic material and general coordination of health.

The State and the Autonomous Communities shall, in the field of their respective competences, adopt the necessary measures to ensure the effectiveness of this Law.

Final disposition second. Extra application.

As not provided for in this Law, Law 41/2002 of 14 November, basic regulation of the autonomy of the patient and of rights and obligations in the field of information and clinical documentation, will be applicable, provided it is not incompatible with the principles of this Law, and the Organic Law 15/1999 of 13 December on the Protection of Personal Data.

Final disposition third. Regulatory development.

The Government is empowered to dictate how many provisions are necessary for the development and implementation of this Law, and in particular to establish:

(a) The rules of exchange and movement, internal, intra-Community and extra-Community, of biological material of human origin for research purposes.

(b) The basic requirements for accreditation and approval of biomedical centres, services and equipment relating to the procurement and use of any biological material of human origin for biomedical research purposes.

c) The operation and development of the Commission of Guarantees for the Donation and Use of Cells and Human Tissue, which will replace the current Commission Monitoring and Control of Donation and Use of Cells and Tissue Humans.

d) The operation and organization of the National Register of Biobanks for Biomedical Research, which will be attached to the Ministry of Health and Consumer Affairs.

Final disposition fourth.

Point 2 of point (A) of the Annex to Law 14/2006 of 26 May on assisted human reproduction techniques is worded as follows:

" 2. In vitro fertilisation and intracytoplasmic injection of sperm with own or donor gametes and with preembryo transfer. "

Final disposition fifth. Entry into force.

This Law shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Therefore,

I command all Spaniards, individuals and authorities, to keep and keep this Law.

Madrid, 3 July 2007.

JOHN CARLOS R.

The President of the Government,

JOSE LUIS RODRIGUEZ ZAPATERO