EU publishes proposed reforms for pharma industry
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The European Union on Wednesday published a long-awaited set of proposals to overhaul the laws governing the region's pharmaceutical industry amid opposition from leading drugmakers.
"Over the last decade, reports of medicines shortages, including of antibiotics, have skyrocketed to the tens of thousands," EU health commissioner Stella Kyriakides told reporters after the publication.
Notable reforms include a proposal to shorten the period of basic market exclusivity that drugmakers can enjoy before generics can hit the market from 10 years to eight. However, drugmakers are entitled to additional two years of exclusivity if new medicines launch in all 27 EU member states within two years.
According to Kyriakides, the incentive program "would provide access to new medicines to around 70 million more citizens compared to today."
She added that there will also be proposals under which "companies will have to notify potential shortages earlier and have shortage prevention plans for their medicines." By the end of the year, the regional bloc plans to prepare a list of critical drugs that manufacturers must stock up.
As the European Parliament, Commission, and member states will discuss the final details of reforms, it will take years before draft proposals can become law following the publication.
However, EU pharma giants, including Novo Nordisk (NVO), Bayer (OTCPK:BAYZF), and GSK (NYSE:GSK), as well as small biotechs, have already voiced concerns noting that the reforms will have the opposite effect and region will lose access to the newest medicines as a result.
The EU must "regulate for growth and competitiveness" as firms "have choices on where our capital and resources are focused," Reuters quoted GSK as saying on Wednesday.
Major pharma companies: Pfizer (PFE), Merck (MRK), Bristol-Myers Squibb (BMY), Eli Lilly (LLY), AstraZeneca (AZN), GSK (GSK), Sanofi (SNY) (OTCPK:SNYNF), Abbott (ABT), AbbVie (ABBV), Gilead (GILD), Johnson & Johnson (JNJ), Biogen (BIIB), Amgen (AMGN) and Moderna (MRNA)
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