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.
"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. — AFP
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