Revision of the European General Pharmaceutical Legislation – Addressing Challenges, Seizing Opportunities

On 13-Mar-2023, PFP.NGO was invited to a European Health Forum Gastein (EHFG) event in cooperation with the Federal Ministry of Social Affairs, Health, Care and Consumer Protection of the Republic of Austria and the Permanent Representation of Austria to the European Union. The event was held in Belgium, and provided an opportunity to address challenges and seize opportunities in regards to the upcoming revision of the EU general pharmaceutical legislation. PFP.NGO was there live, with a special team assembled to convene a discussion on behalf of patients.

The European Commission is due to publish its proposal for the revision this month to ensure a future-proof and crisis-resistant regulatory system. During the event, key experts considered opportunities and lessons learned from the COVID-19 pandemic and discussed ways to ensure the security of access to and supply of medicines for all, even in times of crisis. Discussions acknowledged the importance of fostering innovation and investment in research, and striving for new dialogues between the public and private sectors.

Here’s a summary of Commissioner Kyriakides’ (European Commissioner for Health and Food Safety) opening remarks:

The title given to this event “addressing challenges, seizing opportunities” really fully captures the reform of the  EU pharmaceutical legislation.

Addressing challenges and seizing opportunities. Challenges, we all know exist and need to be addressed in order to deliver what we are all trying to achieve together, and that is an opportunity for change. It is a reform which has been a very long time coming, to address the chronic challenges in this area.

In order to achieve this, we need to work together in a spirit of solidarity, as we have done during this unprecedented public health crisis [COVID pandemic] so that the Member States, the Commission and the EU Parliament achieve what we set out to do – and that is, to solve the problems that everybody has been highlighting for a very long time.

First and foremost, we need to address the interests of patients across Europe. This is an opportunity to put patients at the centre, while at the same time, fully supporting an innovative and globally competitive EU industry. These two objectives, we believe, should be pursued in balance – not as trade-offs.

Delivering on this, is one of the most important tasks in the area of health during our mandate and I can assure you that I am fully aware of the expectations, but I am also fully aware of the concerns.

Our current rules have been put in place in a different era and we need to move with the times. Our citizens, our societies and our economies need a system that will keep pace with scientific and technological progress, and can ensure affordability, access and availability of medicines at all times.

What I would like is that when looking at this proposal, it is important to look at it as a whole, as a toolbox. One part complements the other –  no part of the proposal and no initiative should be seen in isolation. 

So, let me recall the six  key aims we want to achieve with this reform:

  • Firstly, we want to ensure that all Europeans can access both innovative and established medicines when they need them, wherever they may live. The reality today is that in a fragmented internal market, medicines are not reaching patients quickly enough and they are not in all Member States at the same time.
  • Secondly, and most importantly, we want to ensure the EU pharmaceutical industry can innovate and can remain globally competitive. This is why we will make sure we give strong incentives for innovation, especially for unmet medical needs. We will also support patients so they can all access the benefits of this innovation equally. This is a long-standing request from Austria and other Member States. This is why we will reward those who go the extra mile to provide EU-wide access. And herein lies the balancing act that we want to achieve – innovation to serve every patient, equally and equitably, across the EU.
  • Thirdly, this is a reform to address shortages of medicines and a reform to increase our security of supply. There will be stronger obligations on supply and transparency of stocks. Shortages and withdrawals will have to be notified earlier. The European Medicines Agency (EMA) will have a stronger role in coordinating our actions against shortages.
  • Fourthly, we will aim to make medicines more environmentally sustainable. For too long, we have known that pharmaceutical production impacts on our environment and these impacts will now be part of our authorisation processes, and environmental risk assessments are going to be an integral part of authorisation dossiers.
  • Fifthly, we need an ambitious tool, and tools I would say, to combat antimicrobial resistance. This is a silent killer that, at the moment, claims more than 35,000 lives per year. Our pharmaceutical reform is the perfect vehicle and it will include measures, both to stimulate new antimicrobial products, as well as prudent use. We are considering to propose transferable exclusivity vouchers for the development of novel antimicrobials to be granted and used under strict conditions. We will also be looking at procurement mechanisms for access to new and existing antimicrobials that would guarantee revenue, regardless of sales volumes.
  • Last, but certainly not least, as this is the most horizontal of the novel elements we will bring – simplification, regulatory modernisation and digitalisation – a leaner regulatory environment for investment, with simplified and faster marketing authorisation procedures, stronger support for promising medicines and better use of data and digitalisation.

Our ambition is very clear – to put forward, in the coming weeks, a proposal which will be both patient-centered and industry friendly. A balanced proposal, which does not create winners and losers, but builds a virtuous circle between industry and patients, to deliver innovation where it is most needed – to our citizens, across the Union. This requires close cooperation and I count on your support during the negotiation so that together we bring the EU pharmaceutical system into the 21st century.

This is exactly what is meant by addressing the challenges and seizing the opportunities. These are opportunities that must not be lost.

European Commissioner for Health and Food Safety, Stella Kyriakides

PFP.NGO insists on human health rights and access to medicines for everyone – no matter who, or where, they are. They view the lack of access to medicines as one of the most complex and vexing issues that stands in the way of better global health. They firmly believe that people should not be denied access to life-saving therapies for unfair reasons (e.g., economic or social causes). People with life-threatening medical conditions struggle with the realities of health systems, where access to medicines depends on five main dimensions: availability, affordability, accessibility, acceptability and quality. PFP.NGO believes that public-private partnerships are a visible manifestation of the power of collaboration to improve transparent access to medicines.

Executive Director, European Medicines Agency (EMA), Emer Cooke

Author: Sarah Tremethick, PFP.NGO Chief Advocacy and Communications Officer – Board of Trustees

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