I am translating some news that I saw on a Spanish portal (I cannot post the link as it is not in English)
The European Union (EU) has been working for years on a new pharmaceutical strategy to shorten the approval times for new drugs. The urgency in approving drugs for unmet needs or serious diseases makes sense for innovation. For example, if an antibiotic is developed for multi-resistant bacteria, it would be a mistake to spend two years waiting for its approval by the EMA. However, a rapid approval by the European Agency is useless if there is no rapid approval of price and reimbursement in each Member State. In order for Europeans in all countries to have innovative drugs sooner, an acceleration of the regulatory process by the EMA is first required.
Fast approvals
Expedited pathways are accelerated regulatory processes designed to facilitate the faster approval of innovative drugs that treat unmet medical needs or serious diseases. These pathways include mechanisms such as conditional approval, accelerated review or designations such as “Fast Track” or “Breakthrough Therapy” at the FDA and “PRIME” at the EMA. The aim is to reduce the waiting time between the development of the drug and its availability to patients, without compromising the safety and efficacy of the treatment.
Not just survival
The EU is defining the concept of “unmet medical need”, which is key to accessing the PRIME programme. It is essential that this definition is not too restrictive and takes into account improvements in the quality of life of patients. The value of medicines must include how they improve the daily life of patients. If the definition does not contemplate this, Europe will lose opportunities to have more treatments for fast-tracks such as PRIME. From 2019 to 2023, the use of accelerated procedures in approval has been 71% in the United States, 45% in Japan and 8% in the EU. What is the reason for this difference and who is it harming?
The EMA now takes about 400 days to approve a medicine, according to the outgoing Commissioner for Health and Food Safety, Stella Kyriakides. The Commissioner spoke of reducing this time to 180 days without compromising the safety of the medicine. That means halving the EMA approval time. The new commissioner, Oliver Várhely, will certainly endorse this strategy.
A vital strategy
The key chronological milestones in the pharmaceutical strategy start in 2022, when the EC recognises the need to review the European framework due to the growing pressure to improve Europe’s competitiveness against the United States and Asia. The European pharmaceutical legislation package is published in 2023. The then vice-president Margaritis Schinas explained that, after the pandemic, the lessons learned and the more complex world in front of us had to be taken into account. One of the most dynamic sectors had one of the oldest legislations.
“One of the most dynamic sectors [the pharmaceutical sector] had one of the oldest legislations”
Margaritis Schinas, former vice-president of the European Commission
This means speeding up the approval of medicines, increasing investments, securing supply chains on European soil and generally strengthening the pharmaceutical sector. For this reason, last March the EFPIA called for improving this competitiveness through a comprehensive strategy in health and life sciences, with an emphasis on R&D and intellectual property.
Draghi Report
The recent Draghi report on the future of competitiveness in Europe concludes that the pharmaceutical sector in Europe is hampered by a slow and complex process. And this has put in black and white the needs of the EU. There are two options: either promote the innovation-intensive industrial sectors or, in 20 years, we will become an irrelevant continent where we were once leaders. The fact that the re-elected president of the Commission, Ursula von der Leyen, has signed the conclusions of the Draghi report shows the urgency and relevance of this need.
Basically, Spanish pharmaceutical legislation has not been updated for 20 years. In that, we do resemble the statement of “slow and complex” about European regulation, which wants to reduce the approval of a medicine to six months. We are, however, already aware of the need for this change. Precision medicine, AI applied to drug development and advances in digital health make this acceleration a reality, benefiting patients and, ultimately, all of us.