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Proposal for Law No 13 /XII

PL 43/2011

2011.09.01

Exhibition of Motives

The Report of the European Commission's Survey of the Pharmaceutical Sector, concerning the

period from 2000 a to 2007, concluded, in respect of a sample of sales of

prescription drugs expired, worth 50 thousand million euros, that this expense

would have been 15 thousand million higher, if it had not occurred the entry of

generics in the market.

The same Report also concluded that it could have occurred, still, a savings

additional 3 thousand million euros if the generics had entered the market without

delay and that the entry of generics does not always occur as early as it would be possible to

light from the current applicable legal framework. In that document they identify as main

bottlenecking factors the interventions of companies producing medicines

originals in the administrative procedures that aim to grant the authorization of

introduction on the market, the authorization of the sales price to the public and the authorization of the

state turnout in the price of medications, as well as the impugations

administrative of the same decisions.

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The granting of the marketing authorisation, the Commission, in the sequence

of the previously assumed in Common Position No. 61/2003, recalls that the legislation

community that governs the pharmaceutical sector does not provide for the submission of observations by

part of third parties and, less still, formal interventions during the evaluation of an application

of entry permit in the market. In addition, with regard to the pricing

and of the reimbursement scheme, the European Commission understands that the Member States do not

shall accept comments from third parties in which matters related to

the patents. These bottlenecks occur also in Portugal, assorted in the

uncertainty as to the existence of violation, or not, of industrial property rights by

part of the generic drugs that want to access the market, which is heightened

by the particularities of national industrial property legislation, in particular the

non-existent product patent for pharmaceutical specialties up to 1995 and the transition

for the current right.

It has thus been seeing a wide set of litigation in respect of the

granting of the marketing authorisation, of the authorization of the selling price to the

public and the authorization of the state's comstake in the price of medicines

related to the livelihood of industrial property rights in favour of outrain.

However, the question of whether there is, or not, infringement of property rights

industrial depends on sentence to be handed down by the courts.

Through this proposed law the Government intends to establish a mechanism

alternative of composition of disputes which, in a short period of time, profess a

decision of merit as to whether or not to have a violation of property rights

industrial. It is therefore established the recourse to the arbitration required for such composition,

solution already adopted, including in the context of conflicts reaching copyright.

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Still with the aim of promoting speed, deadlines are set for the introduction

of the case and for the opposition, counted from the advertiicitation by the INFARMED, I. P., of the application

of an introduction authorization in the market. Checking the default of the deadline of

opposition, the applicant for marketing authorisation in the generic medicine market

you will not be able to start your industrial or commercial exploitation in the duration of the rights of

industrial property.

It is adopted, still, a consenting springboard with the concern of speed, with

warranty by the adversarial due of the parties, as well as the right to an instance of

resource, fixing the merely discling effect of the same, so as to maintain the effects

of the arbitral decision up to the decision that on the same recair.

On the other hand, and taking into account that national jurisprudence has been understanding that the

industrial property rights may be affected by the granting of the authorizations of

introduction on the market, from the selling price to the public and the state's comparticipation in the

price of medicines, establishes the compatibilty that is deemed to be appropriate

of these rights with others of identical relevance, as is the case with the right to health and to the

access to medicines at affordable costs, as well as consumer rights.

So, and going also to the meeting of the recommendations of the European Commission, it is expected to

expressly that the granting of the said authorisations does not depend on the assessment, by the

competent administrative entities, of the possible existence of property rights

industrial.

Subsequently, it is established, yet, that applications for permission cannot be

dismissed with that plea and that the same authorisations cannot be amended,

suspended or revoked, by the respective issuers, on the basis of subsistence

of these rights.

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Finally, because the elements and documents presented to the INFARMED, I. P., in the

scope of an introduction authorization process in the market are generally

likely to reveal trade or industrial secrets, the presumption is established that

the same shall be subject to secrecy, unless otherwise deliberated by the organ of

direction of the INFARMED, I. P..

It is thus seeking to go to the meeting of what already occurs in other member states of the

European Union and avoid the current practice of companies from all over the Union coming to Portugal

get sensitive information about medications relevant to your markets and that

cannot obtain in these states. Compatibilises itself also the obligation to protect

secret with the principle of open administration and with respect for the right of access,

before the final decision, to a set of information, by the third party that, in the terms

of Article 64 of the Code of Administrative Procedure, demonstrate having legitimate

interest in the knowledge of these elements.

The measures contained in this proposed Act aim to comply with the

commitments made in the Memorandum of Understanding on the Conditionalities of

Economic Policy Fired by the Portuguese Government with the Monetary Fund

International (IMF) the European Commission (EC) and the European Central Bank (ECB), in 17

from May 2011, contributing to the creation of conditions of sustainability of the Service

National Health and access drug users at affordable costs, well

as for the development of alternative means of dispute composition.

In this sense, it is further established that the selling price to the public (PVP) of the

generic drugs to be introduced in the national market is lower at minimum in 50%

to PVP of the reference medicinal product, with equal dosage and in the same form

pharmaceutical, without prejudice to the specifics set out in the legislation on training

of prices of medicinal products.

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Attentive to matter, in the seat of legislative process to be carried out in the Assembly of the Republic,

the competent entities shall be heard.

Thus:

Under the terms of the paragraph d) of Article 197 (1) of the Constitution, the Government presents to the

Assembly of the Republic the following proposal for a law with request for priority and urgency:

Article 1.

Subject

This Law creates a regime of the composition of the emerging disputes of rights of

industrial property when they are in cause reference medications and

generic drugs, proceeding to the fifth amendment to Decree-Law No. 176/2006, of

August 30, amended by Law No. 25/2011, of June 16, and by the Decrees-Law

n ° 182/2009 of August 7, para. 64/2010 of June 9, and No. 106-A/2010 of 1 of

October, and the second amendment to the general regime of state compositions in the price

of the medicinal products, approved in annex to the Decree-Law No. 48-A/2010 of May 13,

changed by Decree-Law No 106-A/2010 of October 1.

Article 2.

Arbitration required

The emerging disputes of the invocation of industrial property rights, including the

cautionary procedures, related to reference drugs within the meaning of the

point ( ii ) of Article 3 (1) of the Decree-Law No. 176/2006 of August 30, and

generic drugs, regardless of whether they are in the cause of process patents, de

product or of use, or of supplementary protection certificates, shall be subject to

arbitration required, institutionalized or non-institutionalized.

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Article 3.

Introduction of the process

1-Within 15 days of the advertise referred to in Article 15 of the

Decree-Law No 176/2006 of August 30, in the wording conferred by this Law, the

interested in wishing to invoke their industrial property right under the terms of the

previous article, must do so with the arbitral tribunal institutionalized or carry out

application for submission of the dispute to non-institutionalized arbitration.

2-A non-deduction for opposition, within 15 days after notification for the purpose by the

arbitral tribunal, implies that the applicant for authorisation, or registration, of introduction in the

generic drug market will not be able to start its industrial operation or

commercial in the duration of the industrial property rights invoked pursuant to the

n. 1.

3-The evidence must be offered by the parties with the respective joints.

4-Presented the opposition is designated date and time for the proof production audience

that there is to be produced orally.

5-A the hearing referred to in the preceding paragraph takes place within the maximum period of 60 days

subsequent to the presentation of the opposition.

6-Without prejudice to the provisions of the general scheme of voluntary arbitration with respect to the

deposit of the arbitral decision, the lack of opposition deduction or the arbitral decision,

as the case, is notified, by electronic means, to the parties, to INFARMED, I. P.,

and to the National Institute of Industrial Property, I. P..

7-Of the arbitral decision rests with the Court of the competent Relation, with effect

merely devolutive.

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8-In all that is not expressly contradicted by the provisions of the

previous figures apply for the regulation of the arbitration centre

institutionalized, the general regime of voluntary arbitration and the approved regulation

by the arbitrators, as the case may be.

Article 4.

Amendment to Decree-Law No 176/2006 of August 30

Articles 19, 25, 179 and 188 of the Decree-Law No 176/2006 of August 30, amended

by Law No. 25/2011 of June 16, and by the Decrees-Law No. 182/2009 of August 7,

n ° 64/2010 of June 9 and 106-A/2010 of October 1, go on to have the following

wording:

" Article 19.

[...]

1-[...].

2-[...].

3-[...].

4-[...].

5-[...].

6-[...].

7-A realization of the studies and tests necessary for the application of the n. ºs 1 a to 6, and

the practical requirements arising therefrom, including the corresponding

granting of permission provided for in Article 14, are not contrary to the

rights relating to patents or supplementary protection certificates

of medications.

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Article 25.

[...]

1-[...].

2-The application for an introduction permit on the market cannot be

dismissed on the grounds of the possible existence of rights of

industrial property, without prejudice to the provisions of Article 18 (4).

3-[ Previous Article No 2 ].

4-[ Previous Article No 3 ].

Article 179.

[...]

1-[...].

2-A authorisation, or registration, of introduction into the market of a medicinal product

may not be amended, suspended or revoked on the grounds of the possible

existence of industrial property rights.

3-[ Previous Article No 2 ].

4-[ Previous Article No 3 ].

5-[ Previous Article No 4 ].

6-[ Previous Article No 5 ].

7-[ Previous Article No 6 ].

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Article 188.

[...]

1-Workers in public functions and other collaborators of the

INFARMED, as well as any person who, on the occasion of the exercise

of your duties, take knowledge of elements or documents

presented to the INFARMED, to the European Commission, to the Agency or to the

competent authority of another member state, are subject to duty

of secrecy.

2-Are confidential the elements or documents submitted to the

INFARMED or to this transmitted by the European Commission, by the

Agency or by the competent authority of another member state, without

prejudice to the provisions of this decree-law.

3-Presume that any and any element or document provided for us

previous figures are classified or are likely to reveal a secret

commercial, industrial or professional or a secret relative to a right

of literary, artistic or scientific property, save if the governing body

of INFARMED decide to the contrary.

4-Without prejudice to the provisions of the final part of the preceding paragraph, the

provision of information to third parties on an application for a permit,

or registration, of introduction into the market of a drug of use

human, is deferred until the making of the final decision.

5-Where the applicant of the information on an application for a permit,

or registration, of introduction into the market of a drug of use

human is a third party which, pursuant to Art. 64 of the Code of the

Administrative Procedure, demonstrates having legitimate interest in the

knowledge of these elements, and has not yet been delivered decision

final on that request, is provided, only, the following information:

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a) Name of the applicant of the marketing authorisation;

b) Date of application;

c) Substance, dosage and pharmaceutical form of the medicinal product;

d) Medicine of reference.

6-[ Previous Article No 5 ]. "

Article 5.

Addition to the Decree-Law No. 176/2006, of August 30

They are deferred to Decree-Law No. 176/2006 of August 30, as amended by Law No. 25/2011,

of June 16, and by the Decrees-Law No. 182/2009 of August 7, paragraph 64/2010, 9 of

June, and paragraph 106-A/2010, of October 1, Articles 15-and 23-A, with the following

wording:

" Article 15.

Advertition of the application

1-The INFARMED, I. P., publicizes on its electronic page, all applications

of authorisation, or registration, of introduction into the market of medicinal products

generics, regardless of the procedure to which the same

obey.

2-A advertised advertised in the preceding paragraph shall take place within the

five days after the course of the period provided for in Article 16 (1) and

contain the following elements:

a) Name of the applicant of the marketing authorisation;

b) Date of application;

c) Substance, dosage and pharmaceutical form of the medicinal product;

d) Medicine of reference.

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Article 23-The

Object of the procedure

1-A grant by the INFARMED, I. P., of an authorisation, or registration, of

introduction into the market of a human-use medicine, as well as the

administrative procedure that it conducts, they have exclusively by

object to the assessment of the quality, safety and efficacy of the medicine.

2-The administrative procedure referred to in the preceding paragraph shall not have by

object to the assessment of the existence of possible property rights

industrial. "

Article 6.

Addition to the general scheme of state commissions in the price of

medications, approved in annex to Decree-Law No 48-A/2010 of May 13

It is added to the general scheme of the State's comprisals in the price of medicinal products,

listed in Annex I to Decree-Law No 48-A/2010 of May 13, as amended by the

Decree-Law No 106. º-A/2010 of October 1, Article 2, with the following wording:

" Article 2.

Scope of assessment and decision

1-A decision on the inclusion, or exclusion, of medicine in the

comparticipation, as well as the procedure that it conducts, do not have

by object to the assessment of the existence of possible property rights

industrial.

2-A The decision referred to in the preceding paragraph is not contrary to the rights

relating to patents or supplementary certificates of protection of

medications.

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3-The request that aims to obtain the decision provided in the preceding paragraphs

may not be dismissed on grounds of the existence of any

industrial property rights.

4-A Decision on the inclusion, or exclusion of medicines in the

comparticipation can only be changed, suspended or revoked on the basis of the

grounds provided for in Article 4 (1) and (2) of the present regime.

5-A Decision on the inclusion, or exclusion, of a medicine in the

comstake cannot be changed, suspended, or revoked with

foundation in the existence of possible industrial property rights. "

Article 7.

Price formation of generic drugs

The selling price to the public (PVP) of generic drugs to be introduced on the market

national as well as those that are the subject of the procedure laid down in paragraph 3 of the article

31. of the Decree-Law No. 176/2006 of August 30 is lower at minimum in 50% to PVP

of the reference medicine, with equal dosage and in the same pharmaceutical form, without

injury to the specificities set out in the legislation on the pricing of the

medications.

Article 8.

Authorisation of prices of the medicine

1-A authorisation decision of the PVP of the medicinal product, as well as the procedure that

to that leads, they have no object to the assessment of the existence of possible rights of

industrial property.

2-A The PVP authorisation of the medicinal products is not contrary to the rights relating to

patents or supplementary medications protection certificates.

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3-The application that aims to obtain the permission provided for in the preceding paragraphs cannot

be undue on the grounds of the existence of any property rights

industrial.

4-A PVP authorisation of the medicine may not be altered, suspended or revoked

on the grounds of the existence of possible industrial property rights.

Article 9.

Transitional provisions

1-A The wording given by this Law to Articles 19, 25 and 179 of the Decree-Law

n ° 176/2006 of August 30, as well as the addition introduced to the general scheme

of the state's comholdings in the price of medicines and the provisions of the article

previous, have interpretative nature.

2-Within the period of 30 days after the entry into force of this Law, the INFARMED, I. P.,

publicizes the elements set out in Article 15 of the Decree-Law No. 176/2006, 30 of

August, in the wording conferred by this Law, referring to medicinal products for the

which has not yet been delivered at least one of the authorization decisions of

introduction into the market, of the selling price to the public or inclusion in the

state comparticipation in the price of medicines.

3-The person concerned has 15 days, to be counted from the advertiment referred to in the preceding paragraph,

to invoke your industrial property right pursuant to Articles 2 and 3 of the

present law.

Seen and approved in Council of Ministers of September 1, 2011

The Prime Minister

The Deputy Minister and Parliamentary Affairs