Aimed at improving the availability of medicines in the EU and making them more affordable, a key EU reform is running into delays, raising concerns among MEPs and patient and consumer NGOs in the face of lobbying from the pharmaceutical industry.
“We have no more time for lobby games, neither do the citizens,” castigated German MEP Tiemo Wölken (Socialists & Democrats).
The proposal, revising twenty-year-old legislation, will be presented on April 26, now assures the European Commission, following having postponed its publication several times.
Health Commissioner Stella Kyriakides justified the latest postponement last week before MEPs by the need to “strike the right balance” between the public interest (of medicines available everywhere in the EU, at reasonable) and “support” for a “competitive” and “innovative” European pharmaceutical industry.
The latter, representing some 840,000 direct jobs in Europe, is headwind once morest the proposal, a version of which was leaked in February, to reduce the period during which a company enjoys exclusivity on a drug.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) sees this as a threat to research and development in Europe, faced with competition from the United States and Asia.
“Dismayed” by the latest report, French MEP Véronique Trillet-Lenoir (Renew Europe, centrists and liberals) deplores “an asymmetry of influence” between the industry and the voice of patients.
“There are drug shortages all over the EU, carriers of rare diseases and children waiting for new drugs,” she storms.
Elected officials are concerned that these delays will jeopardize the adoption of the reform before the European elections of 2024.
– ‘Resist’ ‘Big Pharma’ –
“The Commission is pushing everyone’s patience to its limits. It must publish this reform on April 26, resist the major lobbying operation of + Big Pharma + to water it down, and improve the population’s access to medicines”, urges Monique Goyens, director of the European Bureau of Consumers’ Unions (Beuc).
In an effort to make them more affordable, the Commission planned in the provisional version of the reform to reduce from ten to eight years the period of data protection and market exclusivity on a medicine, during which the marketing of generics , cheaper, is impossible.
A one-year extension of this period would be possible for medicines corresponding to “unmet health needs” but also for medicines marketed throughout the EU, while manufacturers generally prefer to target countries according to the size of their population and the price level practiced. An incentive intended to tackle the inequalities of access to new medicines within the Union – the Baltic countries and certain Eastern States being particularly badly off.
Echoing industry concerns, three German MEPs, Peter Liese, Daniel Caspary and Christian Ehler, from the same party (CDU, Conservatives) as Ursula von der Leyen, wrote to her warning that reducing the exclusivity “would have a negative effect on innovation, and therefore on patients”.
Moreover, faced with resistance to antibiotics, which constitutes a growing global threat, to encourage pharmaceutical laboratories to develop new antibiotics – the development of which turns out to be not very lucrative, since they are intended for moderate use -, the Commission is considering a controversial system of transferable exclusivity vouchers.
This is to allow a company, in exchange for the development of a new antibiotic, to extend the period during which it has exclusivity over the sale of another more profitable product, or to resell this voucher to a other company. An idea opposed by 14 of the 27 Member States (including France, Belgium and the Netherlands).
“This is one of the options currently being considered (…) but if we propose it, it will be subject to extremely strict conditions in order to minimize the impact in terms of cost for health systems”, assured Stella Kyriakides .
Brussels also wants “faster and simpler marketing authorization procedures”, like those which have been applied to anti-Covid vaccines. It also wants to force companies to be transparent regarding their stocks and to report any disruption in supply sufficiently in advance.
