Omnibus Law Amends Pharmaceutical Legislation

On 1 March 2024, the Omnibus Law Amending Certain Laws and Decree Law No. 663 (the “Omnibus Law”), which amends certain provisions of the Law No. 1262 on Pharmaceuticals and Medical Preparations (the “Law No. 1262”) and the Fundamental Law on Healthcare Services No. 3359 (the “Law No. 3359”), was published in the Official Gazette numbered 32476. In the general preamble of the Omnibus Law, it was stated that social and economic transformation, rapidly developing technology, ever-changing and increasing needs and demands necessitated a revision in the health system of the country. Within this framework, it was necessary to make amendments to ensure better and higher quality service delivery and to protect the competitive power of Türkiye in the field of health, and in this direction, it was aimed to comply with the European legislation. During the meetings of the commission and the Grand National Assembly of Türkiye (“Assembly”), motions regarding the unconstitutionality of some relevant articles of the Omnibus Bill were examined, however, despite the proposed text bringing much controversy, it was brought to the agenda of the Assembly and enacted into law in a short span of time. The following section discusses key provisions of the Omnibus Law that could affect the pharmaceutical industry.

I. Amendments Made to the Law No. 1262

About the Licensing of Pharmaceuticals

• In Terms of Time: Pursuant to the Law No. 1262, marketing authorization application had to be addressed by the Ministry of Health within 2 months as of the application’s submission date to the Ministry of Health. The Regulation on Licensing of Human Medicinal Products defined the licensing process to be concluded within 210 days as of the notification by the Ministry of Health as from the commencement of the process. With the Omnibus Law, the 2-month period stipulated in the Law No. 1262 has been repealed and secondary legislation has been referred in terms of the issuance of marketing authorizations. Thus, a legislative basis has been introduced for the practice of 210-days period and harmonization with the actual national practice has been achieved.
• In Terms of Analyses: The preamble of the Omnibus Law explains that repeating analyses of the Ministry of Health during the licensing process cause (i) the prolongation of a licensing process and (ii) economic damage by destroying relevant products due to the expiration of shelf life of the pilot production batches produced. Although it was suggested in the commission meetings to add the licensing process of the European Medicines Agency to the proposed text, pursuant to the amendments made for the reasons listed above, the phrases regarding the requesting for samples at the licensing stage have been removed from the text of the Law No. 1262 and pharmaceutical analyses performed by the Ministry of Health will now be carried out following the issuance of the marketing authorization.
• In Terms of Notification of the Sales Price: Pursuant to the Law No. 1262, the prices of wholesale and retail of pharmaceuticals were required to be notified to the Ministry of Health. With the amendments made by the Omnibus Law, since the sales price is not determined at the marketing authorization application but after the licensing and before the launch to the market in practice, the obligation to notify the wholesale and retail sales prices have been removed from the text of the Law No. 1262.

About the Price Information on the Packaging: Pursuant to the Law No. 1262, product price information had to be on the secondary packaging of pharmaceuticals. Considering that the price of products may change for various reasons in short periods of time during their shelf life and that price information can be accessed by scanning the QR code on a human medicinal product, it is no longer mandatory to include price information on the secondary packaging of a human medicinal product, in line with the amendments made by the Omnibus Law.

About the Determination of the Qualifications of Relevant Legal Entities: In accordance with the Omnibus Law, the qualifications of the legal entities manufacturing pharmaceuticals and launching to the market will be determined by the Ministry of Health, due to the burdensome nature of pharmaceutical manufacturing and launching to the market, requiring long-term investments, and containing serious risk and responsibility. It is anticipated that the Ministry of Health will release a secondary regulation regarding this matter.

II. Amendments Regarding Clinical Research

About the Administrative Sanctions: In the period before the Omnibus Law, there was a gap in the legislation regarding the administrative sanctions to be imposed within the framework of the protection of clinical research participants’ well-being and rights. Even though it was stressed during the commission meetings that the sanctions in the proposed text are not adequate and deterrent, according to the amendments made to the Law No. 3359, an administrative fine ranging from 100,000 Turkish Liras to 1,000,000 Turkish Liras can now be imposed on the sponsors and the transferees of the research that violate the procedures and principles determined by the Ministry of Health, except for the scientific studies or research having solely academic purposes.

About the Research Centers: The Omnibus Law establishes the legal basis for clinical research to be conducted in (i) public health institutions and (ii) research and development centers that meet the qualifications listed in the Law No. 3359.  

About the Mandatory Insurance: Pursuant to the relevant clinical research regulation, insurance is mandatory for research participants who participate in clinical research, except for the subjects participating in the low-risk scientific studies. The principles regarding this insurance were not regulated in any legislation. The Law No. 3359 now details regulations to be introduced by the secondary legislation in terms of insurance. Currently, it is expected from the Ministry of Health and the Insurance and Private Pension Regulatory and Supervisory Agency to issue secondary legislation.

About the Delegation of Duty: The duties of the sponsor can be transferred to a contract research organization in part or in full. According to the amendments made to the Law No. 3359, the procedures, principles, and rules in respect to delegation of duty will be determined by the Ministry of Health, to determine the responsibilities and qualifications of the parties, to standardize the relevant organizations and to ensure that these parties provide services in line with their operation permit through the audit where necessary.

About the Initiation of Research: According to the Omnibus Law, some clinical researches are now exempt from the notification that shall be made to the Ministry of Health after the ethics committee approval in order to initiate the research, for the purpose of initiating the research that do not pose any risk on the research participants in a shorter period of time in line with the international regulations.

Evaluation

Although the Omnibus Law was swiftly taken up and enacted by the Assembly, the amendments made to the Law No. 1262 with the Omnibus Law were first brought on the agenda in the first quarter of 2023. Indeed, last year, a legislative proposal suggesting various amendments in the Law No. 1262 had been submitted to the Presidency of Assembly and even the commission report regarding the legislative proposal had been prepared. However, pursuant to the Bylaws of the Assembly, the said proposal became void as the proposal process could not be finalized in one legislative term. The text of the proposal that became void last year included most of the amendments made to the Law No. 1262 by the Omnibus Law but not the amendments made within the scope of clinical research.

It has been noted that the Omnibus Law’s pertinent revisions primarily seek to increase speed and practicality in real-world applications. Regarding price rises, which are becoming increasingly common in Türkiye, for example, the fact that it is no longer required to include price information on the secondary packaging will be useful in practice. Even so, the healthcare professional groups in the industry were cautious about this adjustment, even though it was created with the intention of expediting the pharmaceutical licensing procedures within the framework of pharmaceutical analyses. In this regard, it was emphasized that completing efficacy and safety studies and safeguarding the public’s health come before expediting the licensing process. It was noted that in order to preserve the public’s health, a “delay” is advantageous because, in the alternative, the individuals who could be injured might suffer irreparable repercussions. However, the relevant Omnibus Law provision’s preamble made it clear that the lack of the Ministry of Health analyses during the licensing stage would not jeopardize the product’s quality or safety; rather, it would allow for more effective control and supervision since samples from the market will be randomly selected for the analyses that follow the licensing processes. Furthermore, the preamble also mentions that, in accordance with the international regulations, only products with the proper serial release analyses can be introduced to the market. Products with high risk assessments, such as biological products and vaccines, will continue to be analyzed by both the manufacturer and the Ministry of Health prior to being release onto the market. However, as the pharmaceutical license process actually takes longer than the time frames specified by the regulations, it is noted that the pharmaceutical industry welcomed the removal of the analysis stage.