9th Dec 2023


A call for closer dialogue in the interest of patients

  • When industry and policymakers engage closely, it can be transformational for patients.
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The EU's ongoing revision of the General Pharmaceutical Legislation has the potential to impact healthcare across Europe for decades to come.

I am committed to helping this revision be a success and I think to do so requires EU legislators, the life sciences industry and all involved to recognise our interdependence in providing the best possible healthcare for patients.

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It is only if the solutions in this legislation work for all, that Europe will have a future characterised by high quality healthcare. One prerequisite is the presence of a strong innovation sector across Europe. This boosts patients' health through access to the latest innovations and heightens EU competitiveness on the global stage.

Currently, whilst almost all parties are united in their belief we need to improve access to care in Europe, there are clear signs that more openness and collaboration is needed before a pragmatic way forward can be found.

Unfortunately, as it stands, some of the proposals, whilst laudable in ambition, are simply not practical. To give an example, the EU is proposing to remove two years of regulatory data protection (part of intellectual property protections) from any product that a pharmaceutical company fails to launch in all EU member states within two years of receiving marketing authorisation.

No one could disagree that we should take steps to address the considerable delays in access to innovation we see in some areas of Europe. The problem with this proposal is that it is not solely within the gift of the life sciences sector to make it happen. While filing for new medicines is our responsibility, the speed of the final reimbursement decision is not down to us alone. It is dependent on many local factors such as a country's health technology assessment (HTA) process, and the availability of clinical expertise and budgetary processes.

We therefore believe it is unrealistic to expect new products to become available in all 27 member states within two years. Our counter-proposal — as part of our membership of EFPIA — is for innovators to commit to file future products for reimbursement within two years in all EU countries. This is something the industry can control and deliver on.

As mentioned before, I believe that we are all trying to achieve the same outcome with this new legislation: excellent healthcare for the citizens of the EU. I believe, too, that we face similar challenges: economic downturn, inflation, instability of war, forcing us all to prioritise budgets and spending even more than before. I therefore believe that the impractical elements of the EU's proposed reforms are not down to different ambitions, but instead because we are not working closely enough together to design solutions that will truly improve patient access in Europe.

We know that when industry and policymakers engage closely, it can be transformational for patients. For instance, the life sciences industry recently worked closely with the EU Commission to examine the European Medicines Agency's review processes. This has now resulted in the introduction of faster and more flexible methods when the EMA assesses highly innovative products. This welcome move has the potential to speed up patients' access to the most life-changing innovations.

My call therefore is for EU legislators and the life sciences industry to use the coming months to work together to revise the proposed reforms to the General Pharmaceutical Legislation, ensuring that the final text provides a sustainable and competitive environment for life sciences innovators across Europe that enables a true change for patients.

Europe has long had strengths that set it apart from other parts of the world, from excellent scientific talent to expansive health coverage for citizens. I hope that, with our long history in Europe, Roche can help restore the kind of relationship between innovators and EU bodies that continues to keep Europe a world-leading life science hub and the cradle of so many advances for patients.

Author bio

Padraic Ward is Head of Commercial Operations for Roche Pharma Europe, China and International.


This article is sponsored by a third party. All opinions in this article reflect the views of the author and not of EUobserver.

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