Position of the Polish Pharmaceutical Sector on the Reform of Pharmaceutical Legislation in the European Union

Discussions among Member States regarding reform of the European Union's pharmaceutical legislation, which aims to guarantee all its citizens access to affordable medicines and development of their production in EU, are coming to an end. This will ensure strategic resilience and autonomy of the Union, economic growth, and stability of healthcare systems in member countries. 

EU is facing shortages of medicines, and dependence on supply of ingredients for their production from Asia has reached 80%. Building the strategic resilience of the EU and its economic development requires restoration of production of the most needed medicines and their ingredients. In the current geopolitical situation and financial challenges associated with increasing the EU's military potential, strengthening competition that optimizes healthcare spendings in the European pharmaceutical market becomes crucial. 

The current EU list of critical medicines for the life and health of its residents must be supplemented with financial tools guaranteeing possibility of their production. Costs of pharmaceutical production within the EU are higher than in Asia, so to restore it in EU, it is necessary to equalize these disparities. A dedicated fund to support the production of critical medicines is needed. 

The existing intellectual property framework in the EU, which guarantees the longest exclusivity periods for medicines in the world, promotes innovation. Extending a drug's monopoly in the European market and blocking price-lowering competition will not increase Europe's innovative potential and will cost EU healthcare systems an additional 20 to 100 billion euros, depending on the length of the monopoly extension. Meanwhile, aligning exclusivity periods with those applicable worldwide and shortening them by, for example, two years would save 10 billion euros annually and increase access to medicines in Central and Eastern European countries. 

It is also necessary to allow all activities related to the registration and reimbursement of a competitor drug during the patent protection period so that it is available from the first day after the monopoly ends. This can be facilitated by a broad Bolar exception, which will guarantee legal security for manufacturers of price-competitive drugs regarding their reimbursement from the first day after patent protection expires. 

In the coming days, it will be decided whether broader access to affordable medicines will be possible. For this to happen, Member States must agree to these solutions. 

The time has come for the EU to oppose attempts to block the reform of pharmaceutical legislation and to support competition in favor of patients. The current review of the pharmaceutical directive can restore competitive balance in the EU market, ensure faster access to drug therapies, increase pharmaceutical production in EU, and promote economic growth and strategic security for its residents. 

Krzysztof Kopeć is President of Medicines for Poland and Bartek Czyczerski is CEO of Business & Science Poland.