Debate: Union code relating to medicinal products for human use - Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
Date: WEDNESDAY, 10 APRIL 2024
Speaker: Margaritis Schinas
Language: EN

From the very start, our objective for this package was clear: to ensure timely and equal access to medicines for all Europeans, regardless of where they live in the Union, whilst at the same time fostering innovation and competitiveness for our industry. Contrary to certain arguments that these objectives are antagonistic or do not combine, I want to take this opportunity today to say that we think that they are both compatible and perfectly feasible. We can respond, with this reform, both to the needs of the patient and the expectations of the market. Indeed, our pharmaceutical sector, our pharmaceutical industry is a European champion. The EU is the second largest market in the world for pharmaceuticals, and pharma represents the biggest single contributor to our trade surplus. So having a robust regulatory environment matters. It matters a lot.  Coming now to patients, we also have inequality and difficulties there. Patients in bigger and wealthier Member States get their medicines first and faster whilst, at the same time, waiting time for patients to have access to new medicines varies from a few months to up to two years across the EU. This has to change, and it is precisely these objectives are what are driving our reform. These two arguments are two sides of the same coin.  We are reforming legislation having in mind three main priorities: first, wider access to medicines through incentives to reward innovation and supply; number two, cheaper medicines through earlier availability of generics and biosimilars; and number three, faster rules, faster procedures, simplification so that the EU and its industry will remain globally competitive.  This is not a theory. This is something that will bring concrete, tangible change on the ground. New medicines will reach 70 million more patients in the EU, especially in areas where treatments are lacking, like rare diseases and paediatric cancers. For the industry, this would entail savings between EUR 500 million to EUR 1 billion over the next 15 years. This is a win win situation.  Honourable Members, I would like to commend this House, the rapporteurs, the shadows, all those involved, because you gave this file all the priority it deserves, and you delivered so quickly. The main elements of what we proposed have been retained, in particular the set-up of an incentive system that is modulated and geared towards results. Other elements of our proposals have been further developed, like the notions of regulatory sandboxes or incentives for priority antimicrobials, and new ideas have been introduced on joint procurement, on Hera, for example.  Some of these proposals raise questions about effectiveness, visibility, red tape, sustainability of health systems. Still, all your thoughts and ideas form a basis for sound interinstitutional discussions. In the Council, Member States have not yet developed a mandate, so the Commission will reserve our position, but we are sure that we can look forward to the next steps and hold honest negotiations based on facts.  By the end of this month, we will launch a coalition to address a collateral but yet connected and burning issue – the one on how to avoid shortages of the most pressing medicines. This will take the form of a Critical Medicines Alliance, under which we will mobilise all stakeholders for the benefit of society.  In concluding, let me reiterate that we are now facing a great opportunity to create a single market for medicines and one that is fair, future-proofed and globally competitive. Let’s seize this moment. Let’s take this opportunity. This is what Europe knows best – smart, proportionate and effective regulation.