The EU’s drug regulations can get a major makeover soon. In a set of proposals, the European Commission looks to address numerous shortfalls troubling the $148 billion pharmaceutical industry. The proposed upgrades give out the most significant revisions across the European Pharma legislation in 20 years and thus look to make the medicines more trustworthy, affordable, and accessible, announced the commission in a recently rolled out statement. However, industry groups as well as executives have already expressed their concerns.
One of the biggest alterations would be a thinner drug authorization procedure. In this proposal, the two committees pertaining to the European Medicines Agency would review the performance as well as safety data during the process of drug reviews. Other committees, like the existing orphan, paediatric, and advanced therapy groups, would get discarded.
In the new framework, the officials are also looking to speed up the timeliness of the review. At present, the average time taken between the submission of the drugs and Europe’s authorization is 400 days. EMA will have 180 days to evaluate the medicine for authorization in case the legislation gets implemented. Thereafter, to give a nod to the EMA-recommended drugs, the commission will have a total of 46 days instead of 67. For drugs that happen to be of major public interest, there would be stricter timelines.
As far as the issue of pricing and access is concerned, the rules roll out a host of changes. The European Commission has proposed shortening the regulatory exclusivity period from 10 years to 8 years for almost all medicines. Organizations can also go on to extend the regulatory exclusivity period if they happen to be launching their product across all the EU member states, address diseases with unmet needs, execute comparative trials, and also launch drugs that happen to be used for the treatment of multiple diseases.
The proposals have already witnessed pushback from the pharmaceutical spectrum. As per the European Federation of Pharmaceutical Industries and Associations, the legislation undermines research as well as development in Europe while also failing to address patients’ drug access needs, said the Director General of EFPIA, Nathalie Moll.
The approach that’s mentioned in the pharma legislation, penalising innovation if the medicine isn’t available across all the member states, happens to be flawed and, as a matter of fact, represents an impossible target for organisations. The European Commission also aims to give thrust to transparency surrounding R&D funding. As per the new rules, the companies will be required to disclose public authorities’ funding for the research. This will go on to lower the price of the drug by giving the EU member states an edge in negotiations when it comes to pricing.
On the other hand, supply issues have already affected the pharma sector across the world. To address this issue in the EU, the legislation specifies that organisations will have to set for themselves shortage prevention strategies for all the drugs. Apart from this, the commission will have to designate certain sets of drugs as critical and thereby closely track their supplies.
Ahead of the release of the proposal, Emma Walmsley, the CEO of GSK, went on to warn that the EU must regulate for growth as well as competitiveness. The pressure to hamper the market exclusivity protections could very well mean that the companies shy away from the research and also do not launch drugs in Europe.
It, however, remains to be seen how the proposals will go on to advance the commission’s regulatory procedures. The next step in line is going to be deliberations in the Parliament and Council of Europe, which are going to begin very soon. These talks across Europe come after both US President Joe Biden and the US Congress went on to pass the Inflation Reduction Act last year. The law provides the government with the authority to penalise companies that raise drug prices faster than the inflation rate.