Feb 28, 2018

Three steps to develop the pharmaceutical market

The pharmaceutical industry is one of the drivers of the economy and security of Ukraine. Domestic production of high-quality medicines minimizes the dependence of Ukrainian manufacturers on expensive imports. This also means jobs, innovative development of scientific potential, and taxes.

Against this background, domestic pharmaceutical manufacturers rely on state support. Even today, it is possible and necessary to adopt several changes that will promote the development of the pharmaceutical industry and deployment of new medicines. Here are the three steps that, in my opinion, need to be implemented in the nearest future.

1) To regulate issues related to the formation of the National List of Essential Medicines

The Resolution of the Cabinet of Ministers of Ukraine approving the National List of Essential Medicines took effect in mid-2017. According to this regulatory instrument, state medical organizations should first purchase medicines included in this list and only after 100% of the need for them is met, prevention and treatment facilities can procure other drugs. However, to date, there is no clear methodology for estimating the need of healthcare facilities for drugs from the National List. If we make estimates and procure drugs for the year, either significant amounts of money will be freezed, or medicines will be purchased in large batches and collect dust on shelves.

It would be more efficient to carry out these procedures at least once a quarter. If a given prevention and treatment facility has procured the need for the quarter, it will be able to purchase other required medicines.

Another important issue is inclusion of new drugs in the National List. Not all important nosologies (diseases – LIGA.net) and medical procedures are covered by this List today. The National List should be expanded with medicines used in modern healthcare standards, as well as to resume the fast track procedure (expedited consideration – LIGA.net) to have drugs entered in the List on request of institutions (prevention and treatment facilities, specialized commissions, etc.) for the most important nosologies.

2) To regulate the issue of intellectual property

Currently, MPs of the Verkhovna Rada of Ukraine are examining a draft law “On Amending Certain Legislative Acts of Ukraine on Improving the Legal Protection of Inventions and Utility Models”.

Its adoption will enable timely and efficient development of generics (equivalents of originator drugs), which will help save companies’ budget, as they will be able to proceed to development of new medicines earlier. It will also have a positive impact on the development of the pharmaceutical industry infrastructure, as companies will start involving institutes and research companies in the development process.

3) To amend the authorization procedure for medicines from highly regulated markets (in particular, the EU)

In 2015, the Ministry of Health began procurement of drugs and medical products through international specialized organizations. Due to this and the European integration of the Ukrainian legislation, pharmaceutical manufacturers obtained a procedure for simplified authorization of drugs from the EU. However, this procedure does not apply to domestic companies that localize these products through technology transfer or in-bulk packaging (in small containers – LIGA.net). The procedure should be extended to companies that localize products in Ukraine. This will promote the localization of these products in the country and deployment of new technologies by domestic companies.

Susana Khalilova, Marketing and Sales Director, Farmak JSC, exclusively for liga.net

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