As part of the EU’s Pharmaceutical Strategy for Europe, the European Commission has come out with a set of proposals to revise EU pharmaceutical legislation. The reforms, which aim to make medicines more available and accessible across Europe by reducing regulatory exclusivity, speeding up review processes and reinforcing supply chains will also, according to the EC, support innovation and boost the EU pharma industry’s competitiveness. Innovators claim the proposed changes will do just the opposite.
The approach, 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
Nathalie Moll, Director General, EFPIA
After a number of postponements, the European Commission (EC) at last presented its proposal for the reform of the European bloc’s medicines legislation, its first major overhaul in 20 years. The EC claims that apart from promoting access, the reform will create an environment in Europe for “world-class innovation.” And while generics makers and patient groups applaud the reform, the innovative pharma industry sees it as a hit to the sector’s competitiveness, much like the Inflation Reduction Act in US or the recent tax hikes for UK drugmakers.
Reduced Exclusivity
We strongly support the proposal’s intention to stop the well documented patent gamesmanship and evergreening and the adaptation of incentives to necessary equity of access across the EU
Medicines for Europe
One of the major issues the new legislation seeks to address is the existing access inequality across Europe with the bloc’s poorer countries normally getting new medicines years after their higher-income counterparts. As an example, Poland and Romania typically wait an average of two years longer to access a new medicines than patients in Germany.
To change this, the proposal puts forth a two-year reduction of the standard 10-year regulatory exclusivity period while introducing incentives for companies to obtain additional competition-free periods. Most importantly, drug makers will be able claim back two years by launching their medicines in all 27 EU markets within two years from the date the marketing authorization is granted. Other ways they can win back competition-free time would be by addressing an unmet medical need, or treating additional disease targets with the same drug.
In innovators’ view, access delays are not a product of favouritism towards richer countries but occur after companies have filed for pricing and reimbursement and are awaiting decisions and the proposed changes will only serve to undermine innovation. “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 Nathalie Moll, Director General, EFPIA in a release.
For the EUCOPE, the organisation that represents small and mid-sized innovative European pharma companies, the proposal introduces more risk and unpredictability while reducing incentives for innovation and investment. “The Commission’s revision includes troubling proposals … which risk reducing the EU’s global competitiveness in life sciences, thereby limiting the development and availability of innovative therapies,” said EUCOPE Secretary-General Alexander Natz.
Seeing as one of its clear aims is to promote faster availability of generics and biosimilars, the proposed reform has been well-received by generics manufacturers. In a statement from Medicines for Europe, the group that represents the generic and biosimilar industries across Europe, the organisation praised the legislation: “We strongly support the proposal’s intention to stop the well documented patent gamesmanship and evergreening and the adaptation of incentives to necessary equity of access across the EU.”
“The long-awaited revision of the EU pharma legislation is here. The central role of the off-patent medicines industry for the patient is clearly reflected in the intentions of the draft legislation, mirroring our commitment to make medicines available when and where they are needed,” said Medicines for Europe President Elisabeth Stampa.
Streamlined Drug Authorisation Process
We welcome the proposals to strengthen incentives for faster launch and early access to medicines for patients
European Patients Forum
Another key component of the proposed legislation is to eliminate some of the red tape around approvals and step-up access by streamlining the drug authorisation process, something that stands to benefit innovative drug makers and patients alike.
Under the reforms, just two committees within the European Medicines Agency (EMA) will access a drug’s efficacy and safety data during drug reviews while the other existing committees, such as the orphan drugs group will be eliminated. Ideally, this would speed up timeliness, reducing the current average lag between a drug’s submission and authorisation of 400 days. Within the new framework, the EMA would have 180 days to review drugs and the approval of EMA-recommended medicines would then take 46 days instead of the current 67 days.
Additionally, within this new approach, the agency would be able to test new regulatory approaches in what the EC has referred to as a “regulatory sandbox” for novel therapies under real world conditions. And, it would also be able to take advantage of rolling reviews and temporary emergency authorizations, measures which proved to be vital during the COVID-19 pandemic.
The European Patients Forum (EPF) applauded the reform. “We welcome the proposals to strengthen incentives for faster launch and early access to medicines for patients and call on the industry to take advantage of these proposals for the benefit of patients,” the organisation said in a statement.
Reinforcing Medicine Supply
An additional access issue the reforms intend to deal with, in light of recent drug shortages across Europe and the during the pandemic, is to reinforce medicine supply in the EU. The new legislation will enhance the monitoring and mitigation of medicines by requiring pharmaceutical companies to report shortages of medicines six months before eventual supply issues and establish shortage prevention plans.
Moreover, the proposal calls for an EU list of critical medicines, or medicines considered to be most critical for health systems at all times, and companies will be supplied with a list of recommendations to strengthen the supply chains of these drugs. The legislation will also enable the EC to introduce measures to strengthen the security of supply, including requirements to establish contingency stocks. It remains to be seen how these proposals would be carried out and what impact they will have for companies.
Other areas the EC is looking to tackle through the proposal are the transparency of R&D funding and anti-microbial resistance.
