It is exciting times ahead for those interested in the future regulation of pharmaceuticals. It should be a priority not only for regulatory nerds like myself. Much have happened since the last update of the EU legislation. New technology has led to increase of the understanding of disease mechanisms and design of “targeted therapies” that more specifically address medical needs – precision medicine. With respect to this, the legislative initiative to stimulate development of new products for rare diseases, launched 20 years ago, has been very successful. But research is developing with for example increasing number of gene and cell therapiesin development offering curative treatment that not only put pressure on the regulatory requirements but may also require a new business model.
One of the focus areas in the EU pharma strategy is fostering innovation, specifically in areas of unmet medical need. The EU system also needs to adapt to new scientific and technological developments through tailored incentives for innovation support. How the innovation strategy will be implemented in the legislation without lowering the requirement for approval remains to be seen. It is not likely that the basic approval requirement to show positive absolute benefit-risk will be dropped.
Given that the commission highlights the technological development and that the new EU-regulation for medical devices was recently implemented it will be interesting see if any new initiatives are taken to simplify for medicinal products with a device component. These include clarifying roles and responsibilities, streamlining requirements and procedures, and building up the necessary regulatory expertise and collaborations. It seems not unlikely that the technological development will lead to that convergence of the pharma and the medical device regulation.
Today, the EU regulatory system is based on collaboration between national medicines agencies and EMA. The Commission will explore the need to recognize more formally the role of the networkof national medicines agencies and its operational structure in the regulatory system which may alter the “power balance” between EMA and national medicine agencies, potentially towards a stronger EMA. Long-term, the collaboration is important not least to make sure using the best regulatory competences throughout EU.
Now starts a huge work to draft new legislation text and the regulatory medicine agencies in EU will have busy years ahead with a vast number of expert groups to deliver the exact wording and I can assure that every single word is important and discussed in detail. One sincerely hopes that knowledge and experience from industry will be carefully addressed in this process.
The intentions from the EU-commission with the new legislation is very promising, but it must be revised in a way not to create further complicated and inefficient processes that will add the EU complexity and drive companies to priorities other regions for approval and marketing of their innovations. So, let’s hope that the Commission succeeds to harmonize the regulatory approval times with those in other parts of the world. It is encouraging to read that “reducing bureaucracy” is one goal of the new legislation, but so far this has not been one of the hallmarks of the EU system.
A challenge for the EU -commission is to deliver a new framework that will also take care of another “pillar” of the pharmaceutical strategy, namely, ensuring that new medicines will be available for all citizens in Europe. Maybe this will be hardest to achieve.
Marie Gårdmark, CEO, Regsmart Life Science
Column written for Life Science Sweden Magazine no 1, 2022
Fotocred: Mari Helin, Unsplash