The Institute for Competitiveness, together with an informal coalition of think tanks and international civil society organisations, addressed a letter to European Health Commission Stella Kyriakides, expressing its views on the EU Pharmaceutical Strategy, through the identification of a number of actions seeking to retain Europe\u2019s competitiveness and ensure health-related innovation while meeting the needs of the population.<\/p>\n
The pharmaceutical strategy for Europe was announced as a cornerstone of the von der Leyen Commission \u2018Promoting our European way of life priority\u2019. Its main objectives are to ensure the quality and safety of medicines and consolidate the pharmaceutical sector’s global competitiveness, as well as to guarantee that all patients can benefit from innovation while resisting the pressure of the increasing costs of medicines. On 1 June 2020, the Commission published the strategy for a pharmaceutical strategy, which included the launch in mid-July of the public consultation now concluded.\u00a0 According to the 2020 Work Programme, the\u00a0Commission is expected to publish\u00a0the legislative proposal on the Pharma Strategy by the end of this year.<\/p>\n
The coalition elaborated four areas on which the future strategy should focus, namely: maintaining high standards of IP protection to promote economic growth and protect the EU\u2019s global competitiveness; strengthening the EU\u2019s innovation ecosystem by ensuring all publicly-funded research institutions can license and profit from their research; reforming the patent system to strengthen R&D incentives for the diseases of ageing and other unmet needs; and finally, ensuring that GDPR does not present a barrier to data-driven drug development in the EU.<\/p>\n
In the coalition\u2019s view, it is fundamental that the strategy must maintain the EU\u2019s high standards of IP protection to retain the EU\u2019s global competitiveness and promote post-Covid economic recovery. The strategy should build on existing EU strengths, especially, its world-leading biopharmaceutical industry, and part of the answer lies in Europe focusing on high-value knowledge-based industries. As well, the Strategy must avoid the temptation to weaken IPRs as a means of containing spending in drugs, given that other cost drivers are at the root of healthcare inflation.<\/p>\n
In their letter, the six think tanks highlight that the EU is home to several major biopharmaceutical companies struggling to create life science innovation clusters to match those in the US and increasingly elsewhere. Compared to international competitors, EU firms generally have difficulties in translating public funding of academic research into patents and innovations that drive economic growth. This is a result of a fragmented and uncoordinated approach to the commercialisation of biopharmaceutical inventions originating from publicly-funded universities. The strategy should therefore consider introducing similar legislation to the Bayh-Dole Act \u2013 the US framework regulating the intellectual property created by universities – to boost Europe\u2019s innovation ecosystem.<\/p>\n
Furthermore, the coalition argues that\u00a0a reinforcement of the patent system is required to align innovation to unmet health needs. The EU\u2019s system of Supplementary Protection Certificates (SPCs) grants up to a five-year patent term extension to compensate for delays in the regulatory approval process, but this is often not enough time to allow a sufficient period of market exclusivity for the most challenging diseases. The strategy must revisit the duration of patent terms in order to ensure that R&D for the most pressing health concerns is given sufficient incentives.<\/p>\n
Finally, in order to strengthen data-driven drug R&D, the think tanks call for a further reform of the GDPR, in order to create a favourable environment for the development of data-driven analytical tools such as Artificial Intelligence, that can be deployed in many areas of the R&D lifecycle, from automatically screening chemical compounds to optimising clinical trials. Facilitating data-driven drug development is crucial to the future competitiveness of the EU life science sector. Therefore, the Strategy should investigate reforms to the GDPR to prevent any disadvantages to EU companies in this vital area.<\/p>\n