The European Commission, an executive arm of the European Union (EU), has revealed proposals geared toward overhauling regulations governing the pharmaceutical industry on the continent. Industry players have, however, knocked the proposals.
The proposed shakeup, which is the biggest of its kind in two decades, is reportedly aimed at helping the pharma industry to remain relevant in a competitive global market. It aims to tackle several issues affecting the industry in Europe.
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Another goal of the reform is to make drugs “more available, accessible, and affordable,” according to a statement from the Commission.
Addressing supply and pricing issues
A major area that the EU wants to improve with the proposed reforms is accessibility to medicine. Supply is a challenge not just in Europe but also globally.
The proposed legislation would require drugmakers to have plans for how to prevent shortages of all their drugs. In addition, certain drugs would be labeled as “critical” and their supplies monitored closely by the Commission to tackle supply issues.
One of the changes aimed at enhancing accessibility seeks to reduce the regulatory exclusivity period for most drugs from 10 to eight years.
However, drugmakers may have their period of exclusivity extended if they make their products available in all member states of the EU. They could also enjoy this privilege if they tackle diseases with unmet need, carry out comparative trials, or bring to market medicines that treat multiple diseases.
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The pharma reforms also look to promote transparency in funding for research and development. Companies would have to reveal funding from public authorities or organizations funded by the government on public websites. The European Commission hopes this could help EU member states to negotiate for lower drug prices.
Faster time to market
With these pharma law reforms, the EU also wants to make it possible for companies to bring new drugs to the market faster.
The average time from drug submission to approval exceeds a year at present, estimated at 400 days. This legislation overhaul aims, in part, to make this authorization process shorter.
Under the new rules, only two European Medicines Agency (EMA) committees will need to review drug efficacy and safety data. Other existing committees, including advanced therapy and pediatric groups, will no longer be needed.
The EMA will take only 180 days to review drugs that are submitted for approval. The European Commission will then have 46 days, previously 67 days, to approve drugs sanctioned by the EMA.
According to the Commission, the EMA will have even stricter review timelines for drugs that are of a “major public health interest.”
Industry pushback
The proposed pharma legislation overhaul has, however, not gone down well with industry groups and executives.
Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), stated in a release that the reforms would hurt R&D work in Europe. The legislation will also fail to address accessibility issues that it seeks to tackle, she argued.
“The approach set out in the pharmaceutical legislation, penalizing innovation if a medicine is not available in all member states within two years is fundamentally flawed and represents an impossible target for companies,” said Moll.
Emma Walmsley, GSK’s chief executive, echoed a similar sentiment. She said weaker market exclusivity could cause companies to not research and launch new drugs in Europe. The EU should rather “regulate for growth and competitiveness,” Walmsley advised.
The Commission disclosed that the next step – reform discussions in the European Parliament – will start “as soon as possible.”
