Brussels: The EU on Wednesday unveiled a long-awaited proposed reform of legislation governing pharmaceutical drugs to make them cheaper, prevent shortages and boost new antibiotic production.
“Over the last decade, reports of medicines shortages, including of antibiotics, have skyrocketed to the tens of thousands,” EU health commissioner Stella Kyriakides told a news conference presenting the recommendations.
The biggest reform of its kind in two decades was in part informed by Brussels’ concerted action during the Covid pandemic that underscored the benefits of less-burdensome procedures, greater transparency and joint measures.
Kyriakides said that, under the proposal, “companies will have to notify potential shortages earlier and have shortage prevention plans for their medicines”.
By the end of this year, Brussels plans to draw up a list of critical medicines that will need to be stocked up by manufacturers.
The pharmaceutical industry intensively lobbied to change some of the proposals, the presentation of which had been pushed back several times.
The industry is especially incensed at a recommendation that the exclusive period companies had selling new drugs in Europe could be shortened from 10 years to eight before patent protection expired.
“Today’s proposals manage to undermine research and development in Europe while failing to address access to medicines for patients,” the head of the European Federation of Pharmaceutical Industries and Associations, Nathalie Moll, said.
The industry also railed against plans for EU-wide access to medicines, saying it would end up “penalising innovation” if a product was not available across the bloc.
Moll called the proposals “unworkable EU-level legislation that is destined to fail”.
While the European Commission aims to bring down the cost of medicines, notably by having more generic drugs on the market, it doesn’t have the power to set prices in the European Union.
That is the prerogative of national governments who negotiate with pharmaceutical groups.
Drug voucher proposal
Commission vice president Margaritis Schinas said that, currently, the bigger EU member states had the clout to get certain drugs faster than smaller ones.
“We want our citizens all over the European Union to have the same level of access to drugs,” he said.
He also said the EU carried out “the biggest ever vaccination programme in the history of mankind” to combat Covid, which showed the benefit of Brussels having more say over broad health issues in the 27-nation bloc.
However, a senior commission official admitted that the proposals would not by themselves entirely address the problem of drug shortages, which result from multiple factors, including that essential ingredients are sourced from China and India.
A parallel policy push by Brussels to secure its own raw materials and to bring in more industrial production to Europe is meant to tackle that last issue.
Another key challenge is increasing microbial resistance to existing antibiotics, which each year leads to 35,000 deaths in the EU.
Because antibiotics are meant to be taken in moderate, defined doses they are less lucrative to pharmaceutical companies than blockbuster drugs.
To address that problem, the commission is looking at introducing transferable vouchers that would allow a company coming up with a new, effective antibiotic to apply a lengthened period of exclusivity to another, more profitable drug, or to sell that right to another company.
Around half the EU member states, including Belgium, France and the Netherlands, are wary of that idea though, worried it would weigh on national health systems.
The European Consumer Organisation has also come out against that proposal.
“But so far, no one has proposed a better system,” said one EU lawmaker, Peter Liese, also a medical doctor considered close to the pharmaceutical industry position.
He said that virtually no new antibiotic had been produced in 20 years. On this issue and others the commission is proposing, “innovation-friendly regulation is indispensable,” he said.
The commission also wants a leaner approval process to get new drugs to market faster, as happened with Covid vaccines.