The EU wants to shorten the term of patents on medicines by two years

The EU clashes with Big Pharma over the price of drugs

Corriere PL – 5 Febbraio 2023 – From Diletta Fileni

European Union reforms aim to get new drugs to patients faster and cheaper, but this is against the interests of Big Pharma. As a result, drug price negotiations are becoming even more complex.

Soaring medical costs are weighing on global budgets as world leaders seek to contain inflation, yet price pressures are straining Europe's supply of cheaper, off-patent medicines. The issue is particularly sensitive in Europe, as demand for healthcare exceeds expectations and the war in Ukraine continues to drive up the prices of everything from energy to consumer goods.

The EU clashes with Big Pharma: why?

The reform project includes changes in the legislation of the European Union (EU) pharmaceutical industry. The plan is to shorten the period during which drug companies can sell their brand-name drugs without competition.

At present, companies that create newly formulated medicines can market them for ten years without fear of biosimilar medicines entering the market.

Ed: The patent of a drug is the marchio di esclusiva dell’azienda farmaceutica produttrice. Il brevetto di un farmaco dura 20 anni (Legge Cee 1768 del 1992) e per tutto questo periodo, l’azienda farmaceutica che ha sviluppato il farmaco lo può commercializzare “in esclusiva”. Il brevetto non corrisponde necessariamente con l’immissione in commercio che può avvenire anche molti anni dopo. Nel caso dei farmaci infatti l’immissione in commercio è regolamentata da una procedura amministrativa che ha lo scopo di valutare la sicurezza e l’efficacia.Tenendo conto che occorrono almeno 10-12 anni perché un nuovo medicinale arrivi sul banco della Farmacia, questo significa che all’azienda rimangono solo 8 per ripagarne (complessivamente) 20. Per questa ragione, è stato istituito il “certificato di protezione supplementare” che è il titolo in forza del quale si prolunga la durata dell’esclusiva brevettuale per un periodo non superiore a 5 anni

The EU wants to shorten this period by two years. This would mean that cheaper drugs will be on the market sooner and therefore accessible to a larger population.

In fact, once a drug's patent expires, many pharmaceutical companies offer generic versions, which can then reduce the price down to 80-90%. Thus, less competition often allows for price increases, but also carries a higher risk of drug shortages.

European citizens need access to innovative and affordable healthcare products and services. Effective competition means that companies that manufacture pharmaceuticals, medical devices, or other health-related products and services compete with each other based on the quality and price of their products and services. As a result, companies are incentivized to invest in the development of new treatments and to charge more competitive prices.

When those circumstances prevail, the citizens win. On the other hand Big Pharma perceives the news in different way. He says Europe already lags behind the US and China in research and development of new drugs. The envisaged amendments are also criticized by Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations, who underlined that the reform of the legislation will cause enormous damage to the competitiveness of the European pharmaceutical industry.

While Roche and Novartis executives said this week they want authorities to see health as an investment rather than a cost. However, it's not as if all hope is lost for the pharmaceutical industry. There are still two months left to officially submit the legislative changes for approval, considering that it spends more than €40 million every year to influence EU policies, employing around 220 lobbyists.