- We have brought to a conclusion negotiations that lasted almost two years. We have reached a consensus, which very many said was actually almost impossible," Minister Izabel Leszyczna said at a press conference on Friday. Coordinating work on the pharmaceutical package was one of the main goals of the Polish presidency, which ends June 30.
The package includes new regulations on the circulation of medicines in the EU. As Deputy Minister Katarzyna Kacperczyk, who is responsible at the ministry for all matters related to the presidency, said, strengthening access to medicines throughout the European Union is one of the challenges Poland has set itself. And in her opinion, it will be achieved, as the new solutions are designed to prevent companies from bypassing smaller, less profitable markets. If a company fails to make a drug available in the right quantity and form, it faces sanctions, and may, above all, lose its patent protection period sooner.
The package also provides favorable changes for generic drug manufacturers. Thanks to the so-called Bolar exception, companies will be able to prepare registration dossiers even before the patent protection of the original drug expires. The possibility for such companies to participate in tenders has also been expanded. - From my point of view, it is extremely important that the Polish patient will have faster access to generic drugs," stressed Health Minister Izabela Leszczyna. Thanks to the solutions included in the pharmaceutical package, generics will be able to enter the market literally the day after the protection of an innovative drug expires.
But the package also strengthens innovative companies, especially in those ranges that involve breakthrough, socially relevant, therapies. Admittedly, the period of basic market protection has been reduced from two years to one, but it can be extended if the manufacturer meets additional conditions - for example, introducing a drug that addresses an "unmet medical need." In addition, an eight-year period of data protection has been maintained - so the EU is expected to remain competitive in the global market. Innovative companies will also be able, when they meet certain conditions, to count on the support of the European Medicines Agency. The EU wants to support companies in developing new antibiotics that work against strains of microorganisms that are resistant to existing drugs. Antibiotic resistance is one of the key public health challenges defined by the European Union.
