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The European Commission wants to make it easier for patients to access cheaper generic drugs, a measure that could seriously affect the revenues of large pharmaceutical companies, according to a draft of a European document consulted by Reuters, according to Agerpres.
The EU executive will present his strategy in the medicines sector in a document to be published on Tuesday, with the aim of making medicines more accessible and preventing the recurrence of supply problems in the first phase of the spring COVID pandemic. -19.
“The Commission will consider specific policies that support increased competition from generics and biosimilars,” the Reuters document said.
The generic versions are cheaper copies of the original pharmaceuticals. They can enter the market after the expiration of the patent that protects the original products and contain the same active substance, meeting exactly the same criteria during development, production and safety evaluation, having the same quality, safety and efficacy as the original products .
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The EU executive’s proposal is that European antitrust rules will be enforced more strictly to prevent licensed pharmaceutical companies from “preventing the entry or advancement of more affordable drugs from generic or biosimilar competitors,” says Reuters.
Possible EU actions planned for 2022 include removing barriers to market entry of generic medicines, increasing adoption by healthcare systems, and clearer provisions for testing patents to support applications for authorization of commercialization of generic versions.
The Commission will also announce that incentives and obligations for pharmaceutical manufacturers could be revised by 2022 to link them more closely with requirements for wider distribution and increased competition. This could require drug manufacturers to make their patented drugs available in all 27 EU member states, otherwise they run the risk of being imposed on a shorter period of time in which they will have intellectual property rights. Small countries are often not on the radar of large drug manufacturers because these markets are less profitable.
Among the medicines for which there are supply problems in the community block are antibiotics and medicines for children suffering from rare diseases. The Commission estimates that 95% of the cases of more than 7,000 known rare diseases have not been treated so far.
Problems in the supply of medicines to the community bloc were exacerbated in the first phase of the coronavirus pandemic, amid export bans and other trade restrictions, and when India limits exports of paracetamol, the painkiller temporarily disappeared from the stores. pharmacies in many states. EU.
The document consulted by Reuters affirms that the measures to be introduced in 2022 will increase the “strategic autonomy” of the EU, including through the rapid notification of deficiencies and greater transparency about stocks.
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