Position of the Polish pharmaceutical sector on the reform of pharmaceutical legislation in the European Union [Promoted content]

The EU is experiencing a shortage of medicines, and its dependence on the supply of necessary ingredients from Asia has reached 80%. Building the EU's strategic resilience and economic development requires restoring production of the most needed medicines and their ingredients. Given the current geopolitical situation and the financial challenges associated with increasing the EU's military potential, strengthening competition that optimizes healthcare spending in the European pharmaceutical market is crucial.

The current EU list of critical medicines essential to the life and health of citizens must be supplemented with financial instruments that guarantee their production. The cost of producing medicines is higher in the EU than in Asia; to restore production in the EU, these inequalities must be redressed. Therefore, a special fund is needed to support the production of essential medicines.

The existing intellectual property framework in the EU, which guarantees the longest exclusivity periods for pharmaceuticals in the world, promotes innovation. Extending a pharmaceutical's monopoly on the European market and preventing price-cutting competition will not increase Europe's innovation potential and will cost EU healthcare systems an additional €20 to €100 billion, depending on the length of the monopoly extension. In contrast, aligning exclusivity periods with globally applicable periods and shortening them by, say, two years would save €10 billion annually and improve access to medicines in Central and Eastern European countries.

It is also necessary to permit all activities related to the registration and reimbursement of a competing drug during patent protection, so that it is available from the first day after the monopoly expires. This can be facilitated by a broadly worded Bolar exception, which guarantees legal certainty for manufacturers of price-competitive drugs regarding reimbursement from the first day after patent expiration.

In the coming days, a decision will be made as to whether broader access to affordable medicines will be possible. For this to happen, member states must agree to these solutions.

It's time for the EU to resist attempts to block pharmaceutical reform and support competition for the benefit of patients. The current revision of the Pharmaceuticals Directive can restore competitive balance in the EU market, ensure faster access to pharmaceutical therapies, increase pharmaceutical production in the EU, and promote economic growth and strategic security for EU residents.

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