inadmissibility of the appeal no. 38/2015 on
review the constitutionality of Law no.
26 of March 13, 2014 amending and supplementing Law No. 451-XV of July 30, 2001
regulating the licensing of entrepreneurial activity

(Regulating the licensing of pharmaceutical activity)


Posted: 02/05/2016
in the Official Gazette

Nr. 25-30
Article No. 5
Effective Date: 10/13/2015

Constitutional Court, sitting in composition:
Mr. Alexandru Tanase, President, Mr. Aurel
BĂIEŞU, Mr. Igor
DOLEA, Mr. Tudor
Panţiru,
Mr. Victor POPA, judges | || with Ms Ludmila Chihai, Registrar,
Considering the complaint filed on September 25, 2015, registered on the same date
preliminary Examining the complaint said,
Considering documents and materials,
deliberated on 13 October 2015 closed hearing
Delivers the following decision: tHE FACTS

1. On 25 September 2015
MP Mrs. Mihaela Iacob sent notification on the Constitutional Court review the constitutionality of Law no. 26 of 13 March 2014 amending Law No. 451-XV of 30 July 2001 on regulating the licensing of entrepreneurial activity.
A.
Two grounds for referral. The grounds for referral, as was exhibited by referral, may be summarized as follows.
March. In order to improve the licensing system in Moldova, Parliament adopted the Law no.26 of 13 March 2014 amending Law No. 451-XV of 30 July 2001 on regulating the licensing of entrepreneurial activity.
4. By Law no. 26 of March 13, 2014 and some amendments were made in art. 8 (1) pct.25) of Law No. 451-XV of 30 July 2001 on regulating the licensing of entrepreneurial activity, namely in the Licensing pharmaceutical activity.
May. By the amendments, Article 8 para. (1) pct.25) of Law No. 451-XV of 30 July 2001 provides that subject to regulation by licensing by the Licensing Chamber pharmaceutical activity, including the use of drugs and / or psychotropic carried out by private and / or pharmaceutical institutions (for newly established enterprises and institutions, to obtain accreditation certificate) unless amended or supplemented type of activity.
June. In the current wording, Article 8 para. (1) pct.25) of Law No. 451-XV of 30 July 2001 lays down that is subject to regulation by licensing by the Licensing Chamber pharmaceutical activity.
July. The author argues that referral, with the amendment of article 8 para. (1) pct.25) of Law No. 451-XV of 30 July 2001 on regulating the licensing of entrepreneurial activity, pharmaceutical faced great difficulties due because of the implementing these provisions.
August. The author considers that the notification provisions of Law no. 26 of 13 March 2014 amending Law No. 451-XV of 30 July 2001 on regulating the licensing of entrepreneurial activity contrary to the provisions of Articles 1 para. (3), 7, 9 para. (1) and (3), 15, 16, 46 and 127 paragraph. (1) and (2) of the Constitution.
B.
Relevant legislation in September. The relevant provisions of the Constitution (OJ 1994, no. 1) are:

Article 9 Fundamentals property

"(1) Property is public or private. It can consist of material and intellectual goods.
(2) No property may be used to the detriment of the rights, freedoms and dignity.
(3) market, free economic initiative and fair competition basic factors of the economy. "

Article 46Dreptul to private property and its protection

"(1) The right to private property and state bonds are guaranteed.
(2) No one may be expropriated except in the public interest, established by law, against just compensation paid in advance.
(3) Legally acquired assets may not be confiscated. Legality of acquirement shall be presumed.
(4) goods intended for, used or resulted from crimes or offenses may be confiscated only under the law.
(5) The right to private property compels to the observance of duties on environmental protection and ensuring good neighborliness, as well as other tasks which, by law, are owner.
(6) The right to inherit private property is guaranteed. "
Article 127Proprietatea



"(1) The State shall protect property.
(2) The state guarantees everyone the right to property as requested by the owner, they do not contradict the interests of society.
(3) Public property belongs to the state or administrative-territorial units.
(4) The riches of any nature, the air, waters and forests used in public interest, natural resources of the economic zone and the continental shelf, passageways and other assets established by law, shall be exclusively public property. "
10. The relevant provisions of Law No. 451-XV of 30 July 2001 on regulating the licensing of entrepreneurial activity (Republished: MO, 2005, no. 26 to 28, Article 95) are:
Article 2Noţiuni main


"In this law the following definitions shall apply:
license - administrative permissive issued by the licensing authority in the regulation of entrepreneurial activity, certifying the right to carry license for a set period, this type of activity in whole or in part, with mandatory compliance with licensing conditions;
[...]. "

Article 8Genurile activity subject to regulation by licensing

"(1) are subject to regulation by licensing the following types of activities:
a) of the Licensing Chamber:
[...]
25) pharmaceutical activity;
[...] "

Article 11Decizia on issuance / extension of the license or the rejection of the declaration for release
/
license extension
"(1) Licensing Authority, in the statement for the issuance / extension license and documents attached, shall decide on the issuance / extension of the license or reject the declaration within 5 working days from filing.
(2) Notwithstanding the provisions of para. (1) where expressly established by laws regulating the licensed activity that may be established for a term exceeding adoption by the licensing authority decision on issuance / extension license or on the rejection of the declaration for issuance / extension license.
(3) The information about the decision on issuance / extension of the license shall inform the applicant no later than the working day following the decision.
[...]
(6) The license shall be deemed issued / extended if the licensing authority license applicant does not respond within the time limits prescribed by law. After the expiry cumulative set for notification about refusal of registration statement for the issuance / extension license about rejection or the decision on issuance / extension license given no written notice of the grounds for refusal of registration and / or rejection of the declaration for issuance / extension license applicant for a license may operate for which the license was requested.
(7) Upon the occurrence as provided in par. (6), the licensing authority concludes the license under Art. 14 (1).
(8) tacit approval procedure laid down in para. (6) applies to all licenses, except those issued by regulatory authorities in the financial sector (banking and non-banking) in activities aimed at the regime of firearms, ammunition and explosives.
(9) negative response, given the limits provided by law, does not constitute tacit approval.
(10) The provisions of this article are applicable to the use of e-licensing service. "
11. The relevant provisions of the Law nr.1456-XII of 25 May 1993 on pharmaceutical activity (Republished: MO, 2005, no. 59-61, article 200) are:


General Article 1Noţiuni
"In this law, the following definitions shall General
pharmaceutical activity - scientific-practical field of healthcare, including drug development, standardization, registration, manufacture, formulation, quality control, storage, information, supply and their release population and leadership of pharmaceutical companies and their subdivisions, activities exercised only within the pharmaceutical enterprise, except for research to develop and test drugs made in accordance with existing legislation;
[...] "

Article 142Exclusivitatea pharmaceutical license pursuit


"License to exercise pharmaceutical activity is the only document required to operate the company and pharmaceutical institutions."

12. The relevant provisions of the Law no.552-XV of 18 October 2001 on the assessment and accreditation in health (OJ 2001, no. 155-157, art.1234) are:

Article 8Consiliul National Assessment and Accreditation in Health

"For evaluating and accrediting institutions and medical and pharmaceutical enterprises, by the decision of the Government, the Ministry of Health established the National Council for Evaluation and Accreditation in Health, hereinafter Council, which has the status of a legal entity and stamp with the state emblem and its name and operate under regulations approved by the Government. "
Article 9Atribuţiile main

Council
"The Council shall exercise the following powers:
[...]
e) decisions on accreditation or non-accreditation, issue or withdrawal of accreditation certificates under the law;
F) decisions on accreditation and issuance of certificates on non-accreditation or accreditation;
[...] "

Article 11Procedura assessment and accreditation

"(1) institutions and enterprises healthcare and pharmaceuticals are subject to state and private evaluation and accreditation, necessarily, once in 5 years.
(2) Evaluation and accreditation is carried out in two stages:
a) initiating the accreditation procedure, which provides application and receipt of the necessary documentation from the Council and the period of self-evaluation;
B) evaluation and accreditation systems to assure quality of services provided by institutions and pharmaceutical and medical companies.
(3) administration of the institution and enterprise healthcare and pharmaceutical start-up calls in one year since the start of the drive, evaluation and accreditation.
[...] "
A
THE LAW. Arguments author of the notification
13. The author argues that the notification provisions of Article 8 para. (1) a) pt. 25) of Law no. 451-XV of 30 July 2001 on regulating the licensing of entrepreneurial activity, the wording of the Law no.26 of 13 March 2014 have been implemented from the day of publication in the Oficial, ie 18 April 2014. Thus, even of 18 April 2014 request by the entities covered by the law to have a license, although to implement the standard set in accordance with the provisions of Article 8 para. (1) pct.25) of law no. 451-XV of July 30, 2001 pharmaceutical business is conducted on the basis of certificates of accreditation, the license is only necessary for newly created enterprises and institutions, to obtain the certificate of accreditation.
14. Accordingly, the immediate implementation of the law had the effect of sanctioning legal persons performing pharmaceutical activity. Or, the entities concerned could not immediately comply with the new requirements.
15. At the same time, by Article II of Law no. 26 of March 13, 2014 the Government is granted a period of 3 months from the date of publication to its normative acts, including departmental, according to the law in question.
16. Author of the notification mentions that the legislature has not set a reasonable transitional period to give businesses the ability to comply with the provisions of Law no. 26 of 13 March 2014 amending and supplementing Law no. 451-XV of 30 July 2001.
17. The author believes that the referral by Law No. 26 of March 13, 2014 the State did not provide one of the fundamental principles of law - equity - and did not ensure entrepreneurship activity conditions under Art. 8 paragraph. (1) and (2) of Law no. 845-XII of 3 January 1992 on entrepreneurship and enterprises.
18. In his view, Law no. 26 of 13 March 2014 led to violation of fundamental principles flagrant property.
B. The Court's assessment
19. Examining the notification in terms of admissibility, the Court finds as follows.
20. Under Article 135 para. (1) a) of the Constitution, Article 4 para. (1) a) of the Law on Constitutional Court and Article 4 para. (1) a) of the Code of Constitutional Court shall, upon appeal, the constitutionality of laws.

21. The Court notes that Article 25 letter g) of the Law on the Constitutional Court and 38 para. (1) g) of the Code of Constitutional empowers the MP with the right to petition the Constitutional Court.
22. The Court notes that the power conferred upon it by that Article 135 para. (1) a) of the Constitution requires the correlation between the contested rules and the Constitution, taking into account the principle of supremacy it.
23. The Court finds that the subject of constitutional control is the Law no.26 of 13 March 2014 amending Law No. 451-XV of 30 July 2001 on regulating the licensing of entrepreneurial activity.
24. The Court notes that the author of the notification invoked the alleged infringement of Articles 1 para. (3), 7, 9 para. (1) and (3), 15, 16, 46 and 127 paragraph. (1) and (2) of the Constitution.
25. The Court notes that although the author of the notification requesting the constitutionality of Law No. 26 of March 13, 2014 in whole, nevertheless submits arguments in its sole amendment to Article 8 para. (1) pct.25 of Law No. 451-XV of 30 July 2001 on licensing of entrepreneurial activity and only in terms of how its implementation.
26. However, examining the issue raised in the reference substance, the Court finds that the author did not criticize the referral separate article content. 8 paragraph. (1) a) pt. 25) of Law no. 451-XV of 30 July 2001 on regulating the licensing of entrepreneurial activity, according to which the pharmaceutical business is subject to regulation by licensing by the Licensing Chamber.
27. Thus, the Court finds that the complaint elucidated aspects by focusing only on how to implement the provisions of Article 8 para. (1) pt. 25) of Law No. 451-XV of 30 July 2001 in the wording of Law no. 26 of 13 March 2014.
28. With reference to the facts invoked by the author of the notification, namely the penalisation of concerned entities (pharmacies) for lacking a license, the Court notes that they are entitled to apply to the courts to defend their rights violated.
29. At the same time, the Court finds no dispute in the courts, in which legal persons operating in the pharmaceutical would raise the exception of unconstitutionality, invoking the alleged violations of constitutional norms.
30. The Court indicates lack of causation between the referral arguments that are focused on how to implement the law and the final requirements, for which notification can not be declared admissible.
For these reasons, in accordance with Articles 26 para. (1) 31 of the Law on Constitutional Court, Articles 61 para. (3) and 64 of the Code of Constitutional Court Constitutional

DECIDED:

1. Declares inadmissible the complaint parliamentarian control Mihaela Iacob on the constitutionality of Law no. 26 of 13 March 2014 amending Law No. 451-XV of 30 July 2001 on regulating the licensing of entrepreneurial activity.
2. This decision is final, can not be subject to any appeal, shall enter into force upon adoption and shall be published in the Official Gazette of the Republic of Moldova.

CONSTITUTIONAL COURT PRESIDENT Alexandru Tanase