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A lawyers’ ambition for 2021

2020... What was that? A year that many of us will want to forget; a year we will always remember. It was such a peculiar and challenging year personally and professionally. It was a year when our industry was asked to stand up and be counted. Now is the time to look back at lessons learned, to think through how we can foster the kind of innovation environment in Europe that can not only solve the current crisis but also better equip the region to address future ones. As Europe maps out the landscape for the next five years with its pharma strategy, are we providing the sector with the tools to innovate, deliver for patients and drive our economic recovery? 

Writing my goals and objectives a year ago, the coronavirus was a new addition to my vocabulary and I had never heard of Wuhan. None of us could have predicted either the scale of global disruption or that within twelve months our industry would have researched, developed, and started delivering multiple vaccines that offer light at what will still be long tunnel.  

Today, we have two vaccines approved by the European regulators and several others underway. Vaccination strategies are being rolled out in the Member States. By the summer, we should be close to herd immunity and something close to a new “normal”.  

The last twelve months have pulled public health into focus as never before. Those in the sector can be proud of our collective response – to COVID, but also to maintaining the supply of the myriad of other treatments and diagnostics in the face of the distinct phases of a global lockdown. This industry has had to overcome enormous challenges such as the huge demand surges at the start of the pandemic due to Europe’s uncoordinated lockdown implementation and the supply issues that followed from this. We have however overcome these challenges and instrumental for that success was the good collaboration with the European institutions including an open dialogue with the competition authorities in our continued efforts to ensure supply of medicines to the patients who need them.  

So how has this contribution played out in the public and political opinion? There has been wide recognition of the role our industry has played in finding a way out from the pandemic. The level of interest in how we discover, develop, test, manufacture and deliver new diagnostics, treatments and vaccines has never been higher.  Our members have featured constantly on the news as the vaccines they have developed, have moved through the process. With this unprecedented interest comes a societal demand for transparency and information; on times-scales, price, liability, distribution and safety.  And more than ever, public opinion matters, as confidence in COVID-19 vaccines are an essential component to reach societal immunity.  

At the political level, against the backdrop of COVID, the new Commission has mapped out its strategic view for the sector for the coming decade.  The Pharmaceutical Strategy published on 25 November 2020 presented a great opportunity “to help ensure Europe has the supply of affordable medicines to meet its needs” and to “support the European pharmaceutical industry to ensure that it remains an innovator and world leader”.  

We had hoped, in particular in view of the lessons learned from the pandemic, that we would see a broad and balanced roadmap, offering a path towards a stronger and more innovative industry, capable of delivering the right health outcomes and of competing on a global stage. What we got is a missed opportunity. 

There are good elements in the Strategy. It recognizes the critical importance of incentives in driving research into areas of unmet medical need and includes a series of measures to tackle antimicrobial resistance and proposals for regulatory innovation, as well as a reinforcement of the European health data space with interoperable systems. However, the good elements do not provide a sufficient counterbalance to effects that undermine incentives to invest in Europe and threaten competitiveness. The policy initiatives at this stage do not include the necessary drivers of innovation and will not solve patients’ access issues. In fact, opening key pieces of legislation proven to stimulate the development of new diagnostics, treatments, and vaccines risks destabilizing Europe’s research ecosystem, accelerating the 25-year loss of cutting-edge research to other regions such as the US and China.  

The pharmaceutical industry shares the goal of fast, equitable and sustainable access to treatments and vaccines. Unfortunately, today we see great disparities and delays in access for patients across Europe. This is not acceptable in Europe that has solidarity as one of its core values.  Thpharmaceutical industry wants to work with all stakeholders to resolve this issue and supports the creation of a High-Level Forum on Access to Innovation. 

Lawyers now have an important role to play in translating policy goals into a regulatory and legislative environment including legislative and non-legislative initiatives, that address the societal concerns of access whilst supporting Europe to be a world leader in medical innovation. Our role goes beyond advice on processes and legal instruments.  

My ambition for 2021 is to deploy, together with my counterparts in companies, trade associations and lawfirms, our legal skills to be enablers of change towards an innovation friendly environment that adequately addresses patient access to the medicines they need. Considering the devastating impact of COVID-19, it is not enough to be looking to see how we can emerge from the crisis, but we need to re-imagine our collective future based on better patient outcomes, on efficient sustainable healthcare which is at the forefront of medical innovation. Through its key policy initiatives such as the pharmaceutical Strategy, the analysis of the orphan and paediatric regulations, the Trade Strategy, the update of the Industrial Strategy, the creation of the new Public Private Partnerships and the Intellectual Proper Action Plan, the EU has the policy levers to strengthen Europe research and manufacturing eco system as well as enhancing the region’s strategic resilience and driving its economic recovery. 

Much to do this year. Upwards and onwards we go! Healthy and happy 2021 for everyone with a hopeful future for science and innovation! 

Kristine Peers

Kristine Peers is General Counsel at the European Federation of Pharmaceutical Industries and Associations (EFPIA).Kristine...
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