The Ministry of Health had two major items on its legislative agenda during the last quarter of 2017, which may impact the manufacturers and importers of human medicinal products, as these items pertain to the manufacturing as well as the pricing of medicines.
On September 29, 2017, the Ministry of Health ("Ministry") published the new Communiqué on the Pricing of Human Medicinal Products ("Pricing Communiqué") in the Official Gazette. Upon the publication of the Pricing Communiqué, the predecessor Communiqué on the Pricing of Human Medicinal Products ("Abolished Communiqué") has been abrogated.
After the new Pricing Communiqué went into effect, the Ministry set its sights on manufacturing plants of human medicinal products and rolled up its sleeves to introduce a new regulation regarding such plants, known as the Regulation on Manufacturing Plants of Human Medicinal Products ("Manufacturing Regulation"). Aiming to regulate the manufacturing and importing of human medicinal products and to bring them in line with internationally acknowledged/implemented standards, the Ministry published the Manufacturing Regulation in the Official Gazette of October 21, 2017. Upon the publication of the Manufacturing Regulation, the predecessor Regulation on Human Medicinal Products Manufactories has been abrogated.
- First Look at the Pricing Communiqué
The Pricing Communiqué adopts a simpler and more user-friendly language regarding the technicalities of drug pricing principles, which are aimed at regulating the Turkish drug pricing system as well as the encouragement of domestic drug manufacturing. The most striking amendment introduced with the Pricing Communiqué is that prices in this market will be amended once a year, rather than the "twice a year" arrangement that was in force under the Abolished Communiqué.
Pricing principles are regulated under Article 7 of the Pricing Communiqué. In this sense, compared to the Abolished Communiqué, it is clearly seen that the Ministry has developed and set forth more detailed pricing principles:
- Transition Period for New Pricing Principles
The Ministry has announced its transition schedule under Provisional Article 1 of the Pricing Communiqué. In this respect, the sales prices to the wholesalers for the products falling within the scope of the following provision, which was abolished by the Decision, will be updated during the real source price amendment period of 2017, in line with their source prices: "The changes in the selling price to the wholesalers approved in Turkey due to the change in reference price or reference country shall not be reflected in the price, unless it exceeds 3%. Only reference and reference country information shall be updated."
Changes that lead to an increase in price will be made upon the request of the license-holders, while changes which lead to a decrease in price will be made by the Institution ex officio. These updated prices will be effective as of the effective date of the final interim list, which will be issued at the end of the actual source price amendment period.
Finally, amendments introduced with the Pricing Communiqué regarding the real source price amendment period will not be applied to the real source price amendment period of 2017, except for Paragraphs 1, 4, 5 and 7 of Article 10. Provisions under the Abolished Communiqué will be taken into account and applied for the real source price amendment period of 2017.
- Manufacturing Plants of Human Medicinal Products in a Nutshell
With the Manufacturing Regulation, the Ministry has broadened the responsibilities of license/permit holders. In this respect, the Ministry has added certain provisions to the responsibility list, which seem to impose a strict monitoring liability to license holders.
For instance, license holders will be responsible for assigning a manager within 30 days after the resignation of the previous manager and notifying the Ministry accordingly. Furthermore, license holders will have to possess and retain the documentation proving that the manufacturers, importers or distributors of active agents with whom they work are duly registered with the relevant authorities in their countries. License holders, in this respect, will have to verify and confirm the safety and quality of the active agents and the inactive ingredients that they use, and ensure that they maintain necessary and adequate control over human medicinal products as well as active agents during all stages of manufacturing.
Article 10 of the Manufacturing Regulation lays out detailed arrangements and instructions with respect to the auditing of human medicinal product manufacturing sites.
Article 13 of the Manufacturing Regulation sets forth important principles regarding the importation of human medicinal products and imposes certain responsibilities on importers and license holders.
The Principles regarding active agents and inactive ingredients are regulated under Article 14 of the Manufacturing Regulation. According to Article 14(2), permit/license holders must confirm that the manufacturers and distributors of their active agents are in compliance with the principles of Good Manufacturing Practices and Good Delivery Practices, by way of auditing the manufacturing and distribution sites of such manufacturers and distributors.
On a side note, as per Article 32 of the Manufacturing Regulation, Article 14(2) will come into effect one year after the date of publication of the Regulation (i.e., on October 21, 2018).
Article 27 of the Manufacturing Regulation provides a more detailed and comprehensive regulation regarding sanctions to be imposed on license/permit holders as well as managers. While the Ministry retains its suspension and withdrawal authority, certain changes made in the Article shed light on the process in the aftermath of a suspension/withdrawal.
Importers who wish to conduct only batch-release operations are obliged to apply to the Ministry and obtain a permit within one year as of the publication date of the Manufacturing Regulation.
This article was first published in Legal Insights Quarterly by ELIG, Attorneys-at-Law in December 2017. A link to the full Legal Insight Quarterly may be found here.
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