A molecular biologist tests wastewater samples for pathogens in the safety laboratory at the John Paul II Center for Molecular Medicine Max Delbrück in Mitte.
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On Wednesday, the European Union launched a long-awaited review of existing pharmaceutical legislation, reflecting the biggest change in regulations governing the industry in decades.
The European Commission, the EU’s executive arm, says reforms it will make the industry more flexible and medicines will become “more accessible, affordable and affordable”.
One of the EU’s main objectives is to ensure more timely and equitable access to medicines for patients in the 27-country bloc.
According to the European Federation of Pharmaceutical Industries and Associations, patients in Germany need around 133 days to access new medicines, compared to 899 days for patients in Romania. The group also found that 92% of “innovative drugs” were available in Germany, compared with 30% in smaller and eastern European EU Member States.
The proposal reduces the period of exclusivity granted to newly developed medicines placed on the market from 10 to 8 years. Companies can extend it to 10 years if they launch the drug in all 27 EU Member States within two years.
A side effect – positive for consumers – would be an earlier drop in drug prices.
However, pharmaceutical companies and lobby groups say the move could hinder innovation and the general availability of drugs.
These measures, they argue, could prove difficult and costly for companies, which may decide not to develop or launch new drugs in the EU at all, putting a bloc behind the US and China.
The head of the pharmaceutical division of the German biotechnology company Bayer, Stefan Oelrich, he told Reuters last week, the changes could have a “catastrophic impact” as companies abandon development projects.
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A Bayer spokesperson told CNBC on Wednesday that the industry’s views were mirrored by EFPIA, the trade group for Europe’s research-based pharmaceutical industry.
Nathalie Moll, CEO of EFPIA, said the group and its members supported the goals of the strategy, but the proposal “manages to undermine research and development in Europe without addressing patients’ access to medicines.”
Moll said the measures set an “impossible target for companies”.
She added that most access delays occur after companies have applied for quotes and reimbursements and are waiting for external decisions.
GSK boss Emma Walmsley he said during Wednesday’s call for payment that the EU must “regulate growth and competitiveness” as pharmaceutical companies “have a choice of where to concentrate our capital and resources,” Reuters reported.
So does the German government warned threats to innovation.
Big changes
A two-year reduction in exclusivity could have a big impact on some companies, especially if it’s a rare drug, Arpita Singhal, managing director of drug
She said a lot of value could come from the last two years as this is the point where the drug has increased its reach.
“In this market, the competition doesn’t necessarily have to be better than you to kill you. It just needs to be good enough to treat and at a lower price,” Singhal said.
She added that going beyond the largest markets and negotiating in so many countries at an early stage would have a significant impact on business plans, though Singhal noted that the regulations could be successful if conditions were made clear.
Roland Wiring, a life sciences lawyer at CMS, agreed that this would represent a very significant change for the industry, but warned that many companies still face supply issues and other challenges.
“This increases the risk for companies entering so many markets, each requiring its own negotiations, so it’s possible they may choose elsewhere. Particularly for medium-sized companies, they will have to decide whether to go to the US or wait until we are ready to roll out across the EU?”
Monique Goyens, director general of the European Consumers’ Organisation, said the proposal was “good news” as it “could make it easier for patients to gain early access to cheaper generic medicines”.
But Goyen criticized some details, adding that “the creation of exclusivity vouchers that would give a pharmaceutical company developing a new antibiotic the opportunity to extend the period of exclusivity for another drug of its choice undermines other benefits of the reform. There are fairer ways to develop new antibiotics.”
Legislative changes can now be debated for months or even years.
The proposal also includes reforms to speed up approval times for new drugs and prevent shortages but streamline regulatory processes.