Q&A on the 2016 EU Health Policy Agenda

2f73927Thom Thorp was appointed in 2015 to head up Lilly’s Government Affairs and Communications for Europe and Canada in addition to his role as Senior Director for Corporate Affairs and Market Access in the UK and Northern Europe. Thom started his career at Lilly in the Brussels Public Affairs office nearly a decade ago. As he comes back to the Brussels health policy scene, he gives LillyPadEU his take on the year ahead.

 

This year kicks off a new trio presidency, formed by the Netherlands, Slovakia and Malta. How much attention can we expect the trio to dedicate to health at a time when the EU is facing such a multitude of challenges?

It’s difficult to predict whether the EU will be going through calm or stormy waters in the next 6-18 months, but with the passing of the baton to the next trio presidency, we at least have some degree of stability and predictability in the policy scene through to June 2017.

The health emphasis of this trio outlined so far ultimately centres around unpicking how best to create more sustainable health systems across Europe, encouraging cross-border cooperation and driving progress on horizontal issues including R&D and access to innovative medicines. We also still see a disease-specific approach with a particular focus on dementia, which continues to be a priority for the Dutch Presidency as well as for us here at Lilly going back more than 25 years of research and development in that space.

 

The balancing act continues between how best the EU can add value in healthcare, while not impinging on Member State subsidiarity. Nevertheless, there are a few areas in which the EU has stated it has the explicit mandate to act, including Heath Technology Assessments (HTA). How does EU action on this front translate into added value for patients?

HTA is an intricate process, and an instrumental one, with a lasting impact on the speed in which new medicines reach patients in need. Today there are over 60 HTA bodies across Europe that carry out the same exercise for a new health technology (such as a medicine). It’s easy to imagine how such a set-up can lead to unnecessary delays in patient access in some countries.

European action on HTA is essential to avoid multiple assessments, and ensure timely and equal access to health technologies for patients across Europe. The key is smart collaboration and the creation of a framework for sharing information where relevant to reduce duplication of work. This needs to be balanced with HTAs providing vital local insights so that the health decisions fit the local context and reflect the peculiarities of each healthcare system. Greater harmonisation can be best achieved in our view around the clinical assessment of the relative efficacy of a new health technology, whilst still leaving national HTA bodies to make their own decisions around the budget impact of any new medicine. We’re also hoping to see a system that leads to greater involvement of patients at the heart of the process, as we believe any European element should ensure the voice of the patient is incorporated.

The period of 2016 – 2019 is the last chance under the current HTA strategy to get HTA in Europe right and lay the foundations of a permanent and sustainable network of HTAs in Europe. The Dutch National Health Care Institute (the Zorginstituut Nederland) has taken over the secretariat of the EU’s new joint action on HTA (Joint Action 3) that is now being put together, with a current kick-off date in March. From our experience with pilot projects, we believe that the concept is sensible and offers the potential of achieving efficiencies and helping reduce inequalities in medicines availability in Europe.

 

As it is US President Obama’s last year in office, how important is 2016 for the success of the Transatlantic Trade and Investment Partnership (TTIP) negotiations between the EU and the US?

Is 2016 a big year for TTIP? The answer is, indisputably, yes. Are we sure negotiations will come to a close this year? That question is a bit trickier.

TTIP marks a big opportunity for health in Europe. At Lilly, we see TTIP offering the potential to reduce the duplication between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) through mutual recognition of Good Manufacturing Practices (GMP) inspections, aligning processes in paediatric medicine development and avoiding redundant clinical trials on children as well as creating a single system to report data from clinical trials. These would each contribute to accelerating patient access to effective treatments as soon as possible.

Besides setting high global regulatory standards, TTIP also provides the opportunity to include transparent and predictable principles for pricing and reimbursement of medicines and to enshrine EU and US standards for the protection and enforcement of intellectual property. This will help pave the way for continued pharmaceutical innovation and the next generation of medicines.  

With these prospects in health and across other industries, it is no surprise that neither the European Commission nor the US Trade Representative want negotiations to be drawn out for the foreseeable future. 2016 remains the target, but what is most important is to get a good result.

 

We hear a lot about the need for Europe to remain competitive in a global market, and the current Commission’s focus on boosting jobs, growth and investment. Is the EU a leading region for medical and scientific innovation?

Europe has a very strong track record of scientific breakthrough, and with an 800,000-person strong workforce, the European Commission has referred to the pharmaceutical industry as a cornerstone of the knowledge-based economy. Yet Europe is still recovering from a lost decade of economic growth. So how can we bolster medical innovation? Stability and predictability in the healthcare environment, including rewarding the high risk investment of medicines R&D through the protection of intellectual property, and providing patients with faster access to innovative and effective treatments. As a business with R&D in both Europe and the US, we also clearly see the benefits of regulatory alignment that TTIP will bring, providing a much needed boost to scientific innovation in Europe, a stronger industry globally, and the continuation of life sciences jobs here in Europe.