The European Commission on Wednesday proposed a reform aimed at forcing pharmaceutical companies to guard against shortages, but also encouraging them to develop new antibiotics and launch their drugs across the EU.

Highly anticipated and postponed several times, this draft legislation was immediately criticized by the pharmaceutical industry, which sees in it a risk of “sabotage” research and development in Europe.

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 recently the abortion pill in France.

“Over the past decade, reported drug shortages have skyrocketed,” said European Health Commissioner Stella Kyriakides.

The reform provides that companies will have to quickly report possible stock shortages and put in place plans to prevent shortages. Brussels must 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, recalling that the EU was also working to strengthen its industrial sovereignty and secure its supply of critical raw materials.

The reform also intends to make drugs more affordable, by promoting the arrival of generics.

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.

However, the EU does not have the competence to set the prices of medicines, which are the responsibility of the national authorities in the context of negotiations with the manufacturer, as well as the reimbursement rates.

Companies will be able to extend their exclusivity rights for two years if they launch their new medicines in all Member States.

A way of tackling inequalities within the EU, between the most populous and richest countries on the one hand, and on the other the smaller states of the East especially, the worst off. “We cannot have two classes of citizens”, insisted Stella Kyriakides.

Additional deadlines 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 a set of conditions to have up to 12 years of exclusivity, against 11 currently. For rare diseases, the duration may extend up to 13 years.

This system is among the most generous in the world for the industry, argues the Commission.

But the European Federation of Pharmaceutical Industries and Associations (EFPIA) lamented that the project “penalizes innovation”, judging that making a drug available in all Member States in two years was an “impossible objective”.

Without substantial changes to the text in the upcoming negotiations, “Europe will only be a consumer of medical innovations made elsewhere in the world”, she warned.

Oxfam blasted in response “crocodile tears” and “ridiculous threats” from pharmaceutical companies, which “can use this legislation to extend their exclusivity even further”.

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 combat this growing threat and encourage the development of new antibiotics – which prove to be unprofitable 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 arouses the reluctance of half of the Member States (including France and the Netherlands), who consider it too expensive for the health systems.

Brussels is also planning faster and simpler marketing authorization procedures, like those that have been applied to Covid vaccines. The duration of evaluation by the European Medicines Agency (EMA) will be reduced to 180 days, compared to an average of around 400 days currently.

26/04/2023 17:45:44 – Bruxelles (AFP) – © 2023 AFP