Decisions in Healthcare are being accepted, but very slowly

Business community appreciates yesterday’s adoption of amendments to the CMU Resolution #376 which repeal reregistration of medicines for the treatment of tuberculosis, HIV/AIDS, viral hepatitis, cancer and rare diseases registered in the United States, Switzerland, Japan, Australia, Canada and the EU countries.

Changes to the Resolution №376 cancel the registration of medicines for every five years that was not consistent with the European practice and hampered business activity for producers of medical products. The adopted amendments have been developed by Chamber experts in accordance with EU legislation that is in line with the Governmental program of implementation of the EU-Ukraine Association Agreement.

Besides, the amendments to Order of the Ministry of Health №426 dated 26.08.2005 regarding facilitation of medicines examination and registration should be finalized and adopted in the near future. Adoption of these documents should expand significantly the access of patients to high-quality pharmaceutical products, in particular, innovative medicines which are important and vital for patients.

The Chamber has already received a request from the representatives of the State Expert Center of the MoH of Ukraine regarding participation in the development of these amendments, and that is formally agreed with the line Ministry. We do hope that the updated procedure of medicines reregistration will soon be introduces in practice.

Also we do note that these expert recommendations were highlighted in "Vision 2020" strategy presented by the Chamber on November 17, 2014.

Taras Kachka, Acting President of the American Chamber of Commerce in Ukraine notes in this regard: “Adoption of amendments to the Resolution №376 is positively evaluated by the business community. However, in agenda there are many other solutions, important for the industry, but they are still not accepted. It is primarily about changes to the procedure of medicines procurement with WHO and UNICEF involvement; adoption of the Draft Law on Medicines №2162, which provisions were also developing by the Chamber experts for 8 months; improvement of the intellectual property rights protection of producers of medicines; implementation of improved procedures of work of medicines producers in Ukraine which have already passed inspection in the EU and meet the international system of rules of medicines production; and the adoption of the National Strategy for Healthcare Reform. It should be also noted on a number of Draft Laws (№2150, №2151, №2162), which are currently pending at the VRU Committee on Healthcare, on which depends the acceleration of their adoption".