Revamped EU drug regulations increase accessibility but limit innovation?
The European Union’s pharmaceutical industry could face a serious change in operations after Brussels published a proposal for the revamping of certain laws governing the industry.
As one of the biggest modernisation of these laws in 20 years, the market will see a shift in access across European countries to new treatments and generic drugs. The changes should serve to reduce the difference in accessibility to certain medications, and the difference in prices that can be seen in drugs.
One of these amendments includes reducing the length of time a drugmaker can claim exclusivity over a generic from 10 years to eight. However, companies can still earn two further years of protection by launching any new medicine in all 27 member states within the first two years.
EU Health Commissioner Stella Kyriakides stated that the new system "would provide access to new medicines to around 70 million more citizens compared to today".
The EU Health Commission states the overhaul will create a single market for medicines in Europe, shifting the focus on to better provision of healthcare rather than playing to the pharmaceutical industry with overly generous incentives.
Pharmaceutical companies have voiced concerns over the reforms, convinced that it will curb innovation by removing the competitive edge, rather than increase it.
CEO of Novo Nordisk, Lars Fruergaard Jørgensen stated on Wednesday that "the proposals are poison for innovation and competitiveness in Europe."
GSK affirmed that the EU must "regulate for growth and competitiveness" because companies "have choices on where our capital and resources are focused".
The aim of the alterations is mostly to ensure that drug shortages, such as we’ve seen in the last few months, will not occur again, with a failsafe meaning that companies will have to disclose any issues with the supply chain earlier on so that contingencies can be made. The regulations also hope to make the regulators int eh Eu more efficient and improve the speed at which new drugs can be approved for market.
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