2023-04-26 14:09:29
The European Commission proposed a reform on Wednesday aimed at forcing pharmaceutical companies to protect themselves against the shortages affecting the Twenty-Seven, but also encouraging them to develop new antibiotics and to launch their drugs throughout the EU.
Stock-outs or supply tensions on medicines, particularly glaring during the Covid-19 pandemic, notably affected widely prescribed antibiotics such as amoxicillin, but also paracetamol or even recently the abortion pill in France.
“Over the past decade, reported shortages of medicines, including antibiotics, have skyrocketed to tens of thousands,” said EU Health Commissioner Stella Kyriakides as she unveiled a review of current legislation. , 20 years old.
Highly anticipated and postponed several times, this reform has generated intense lobbying from the pharmaceutical industry.
“Companies will need to flag potential shortages earlier and have prevention plans for their drugs,” Kyriakides continued.
Brussels plans to draw up a list of essential medicines by the end of the year, which can then serve as the basis for an obligation to build up stocks.
Drug shortages are linked to several factors, including the concentration of active ingredient production in a few Asian countries, notably China and India.
The proposal will not solve the whole problem, admits a senior Commission official, pointing to the measures presented elsewhere by Brussels to secure its supply of critical raw materials and attract industrial production to Europe.
The reform also intends to make drugs more affordable, by promoting the arrival of generics and by requiring laboratories to be more transparent about the public funds received for research and development.
No “2nd class citizens”
It reduces from ten to eight years the guaranteed period of data protection and commercial exclusivity on a drug, during which the marketing of cheaper generics is impossible.
The EU hopes in this way to help bring down the prices of medicines. However, it does not have the power to set these prices: they are the responsibility of the national authorities, within the framework of negotiations with the company marketing the medicine, as are the reimbursement rates.
But companies will be able to extend their exclusivity right for two years if they launch their medicines in all Member States.
One way to tackle inequalities of access in the EU: while patients in the western and most populous Member States have access to 90% of new medicines, this figure is only 10% in small Eastern countries, emphasizes Stella Kyriakides.
“We cannot have first and second class citizens,” she said.
Additional time will be granted to manufacturers of drugs corresponding to “unmet health needs” or capable of treating other diseases in particular, which may allow companies meeting all the criteria to have up to 12 years of exclusivity, against 11 currently. For rare diseases, the duration may extend up to 13 years, against 10 currently.
Another major challenge to which the legislation seeks to respond: resistance to antibiotics, which kills some 35,000 people each year in the EU.
To fight against this growing threat and encourage the development of new antibiotics – which turn out to be not very lucrative since they are intended for moderate use – the Commission is proposing a controversial system of transferable exclusivity vouchers.
This is to allow a company, in exchange for the development of a new antibiotic, to extend by one year the period during which it has exclusivity on the sale of another more profitable product, or to resell this voucher to another company.
The idea, which had leaked a few months ago, had aroused the reluctance of half of the Member States (including France, Belgium and the Netherlands), who considered it too expensive for the health systems. The European Bureau of Consumers Unions (BEUC) has also denounced such a prospect.
Brussels is also planning faster and simpler marketing authorization procedures, like those that have been applied to anti-Covid vaccines.
The duration of evaluation by the European Medicines Agency (EMA) will be reduced to 180 days, compared to an average which currently stands at 400 days.
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