Last week, the European Commission published a blueprint for the future of medicines innovation. The EU Pharmaceutical Strategy lays the foundation for a lively debate on the development and adoption of new medicines over the coming years. As Europe loses ground to the US and China in originating breakthrough treatments, the Strategy seeks to help reclaim the innovation agenda. The effort is likely to have mixed results.
For 25 years or more, the tide has been going out on Europe’s leadership as a global medicines innovator. It has been struggling against stiff competition from the US and China for cutting-edge science and investments. Choosing the right policy options in tackling the right issues will be critical in preventing a further loss of competitiveness.
The Strategy recognises the importance of incentives in driving research in areas of unmet medical need. COVID-19 has billboarded the importance of science in the search for a way to right a ravaged world. The Strategy includes measures to tackle antimicrobial resistance (AMR). AMR, unlike pandemics, is predictable. We know the bacteria that pose the greatest risks to human health. The UN estimates that, left unchecked, drug-resistant diseases could cause 10 million deaths annually by 2050. As well as the human toll, that would have a catastrophic effect on the global economy.
The pipeline of new antibiotics is not enough to treat future resistant infections. New antibiotics should be used carefully and held in reserve or used only as a last resort. So, industry needs a better underlying commercial model to invest in research and development. That is where incentives, especially for novel antimicrobials, come in. They help us to find answers to common health challenges.
For some time, we have called for a data capture and analysis architecture for tracking and measuring health outcomes, creating the foundation for personalised medicines, optimising prescribing patterns and establishing ‘value’ metrics for the pricing of medicines. The pandemic has underlined the importance of health data in driving medical research, managing healthcare systems and supplying diagnostics, treatments and vaccines. The Strategy includes new initiatives to support the effective use of health data, in particular establishing the European Health Data Space and creating an interoperable data access infrastructure to facilitate secure analysis of data across Europe.
It has ideas for evolving Europe’s world-class regulatory system, including strengthening the iterative scientific dialogue and the dynamic regulatory assessment, using real-world evidence in regulatory decision-making, creating a pathway to streamline the regulation of drug-device combinations and promoting innovative trial designs.
Along with our colleagues at EFPIA in Brussels, we support the European Commission’s efforts to harmonise the EU Special Protection Certificate framework – an IP measure that stimulates the development of medicines by recognising the increased time it takes to bring new treatments to the market.
But there is much in the Strategy to be concerned about. We believe in predictable and sustainable budgeting for affordable innovative medicines. We want to help tackle barriers and delays in patients’ access to new medicines, as well as helping to overcome affordability challenges for health systems. But the Strategy’s approach to addressing access and affordability is wrong.
The Strategy suggests eroding incentives designed to support innovation, including for medicines for rare diseases and children, as a way to address access and affordability concerns. That risks undermining the overall objectives of the Strategy by creating uncertainty and accelerating the flow of life sciences investment away from the EU to the US, UK and China.
There is a commitment to “support[ing] the competitiveness and innovative capacity” of industry and to become a “global standard-setter in [intellectual property]”. But then, in the Action Plan on IP, there is a reference to coordinating compulsory licensing in emergency situations in Europe. That incongruity places at further risk any incentive to invest in medicines innovation.
By adopting the right multi-stakeholder collaborative approach and choosing the right policy options, we can avoid these risks. In turn, we can create faster, more equitable and sustainable access to new medicines for patients in Ireland and across Europe.
The European Commission has the chance to back innovation through through a High-Level Forum on Better Access to Health Innovation – an initiative pressed hard by EFPIA. It should involve medicines innovators more transparently in policymaking. COVID-19 has demonstrated their value-add. So have the preparations for Brexit, whether there is a trade deal or not. This collaborative approach is the way forward, especially since Europe has a strong and stable research ecosystem, clusters of biopharmaceutical companies, and a regulatory system that can adapt at scale and speed to new demands.
As Europe’s economy emerges from COVID-19, our industry will be at the heart of the fightback. In Ireland, we are here in the crisis. In the recovery, we will be here too.
Bernard Mallee is Director of Communications and Advocacy at the Irish Pharmaceutical Healthcare Association.