2024-04-11 14:31:49
The European Parliament voted today to oblige pharmaceutical companies to guard against drug shortages and encourage the development of more affordable generics, while encouraging them to develop new antibiotics, reported AFP.
The text voted by MEPs will be subject to negotiations with member states after the European elections in June.
Long-awaited and repeatedly delayed, this draft law was proposed by the European Commission in April 2023 and was immediately criticized by the pharmaceutical industry, which saw in it the risk of “sabotaging” scientific research and development.
The purpose of the draft legislation is to help reduce shortages or pressures on the supply of certain medicines, such as widely prescribed antibiotics such as amoxicillin, but also common medicines such as paracetamol and abortion pills.
The text obliges companies to immediately report any stock-outs and put plans in place to prevent shortages, starting with the 200 or so “critical” active substances that Brussels recently added to the list.
The reform also aims to make medicines more accessible by speeding up the entry of generic medicines: it reduces to nine and a half years the period of data protection and market exclusivity for a medicine, during which they cannot be placed on the market cheaper generic drugs. This term is longer than the 8 years originally proposed by the European Commission.
Despite some improvements in the original text, “it is difficult to see how reducing incentives for research and development of new medicines and vaccines can be in the interest of Europe or European patients,” the European Federation of the Pharmaceutical Industry said.
However, manufacturers of medicinal products responding to “unmet health needs” or for the treatment of rare diseases will be granted an extension of this protection (up to 11 years in this case).
Another challenge that the legislation is trying to address is antibiotic resistance, which causes around 35,000 deaths in the EU every year, writes BTA.
To encourage the development of new antibiotics, the text introduces a system of so-called exclusive rights vouchers. Under this system, in exchange for developing a new antibiotic, a company would be able to extend by one year the period during which it has exclusive rights to use it.