On Tuesday, 20th October in Brussels, PubAffairs Bruxelles hosted a discussion on the theme “can the EU win the global race in life science research and development?”, with Dr Phillipe Cupers, Acting Head of Unit, Strategy Unit, DG Research and Innovation, European Commission; Dr Pierre Meulien, Executive Director Innovative Medicines Initiative; Prof Sofie Bekaert, Head of Department, Bimetra Clinical Research Centre Ghent University and Mr Alain Baetens, Head of Listings, Euronext Belgium.The event was moderated by Matthew Newman, Senior Correspondent for Mlex
During his introduction, Matthew Newman gave an overview of the pharmaceutical sector as a crucial component of the EU economy and of its valuable contribution in terms of welfare and employment in the EU. He also pointed out that, although the investments in R&D in Europe have grown, the European Union is struggling to maintain its assets while considering innovation indicators such as research and development intensity, development expenditure and patent applications. Subsequently, he presented the speakers, as well the subjects which the debate would touch upon.
Mratthew Newman concluded his introduction by asking a yes/no question to the public and to the speakers, namely: “Is the EU well positioned to win the global race in life science research and development?”. He then gave the floor to the discussants who could proceed to give their preliminary remarks and to discuss the issues at stake.
Dr Cupers replied to the preliminary question by emphasising that winning the global race in life science research and development as well as boosting jobs and competitiveness are main priorities of the Juncker Commission. For this very reason, the Horizon 2020 programme has adopted a new approach by coupling research and innovation. Dr Cupers underlined that Horizon 2020 provides the best conditions for research and businesses to excel in global competition. As a result, the European Commission has further differentiated the typology of research projects in order to provide the actors involved with the most appropriate research instruments. In this regard, he mentioned the collaborative research schemes for translational research, the SMEs instruments scheme, the loan schemes (with forgiveness options to de-risk research projects in the area of infectious diseases), public-private partnerships and public-public partnerships. Dr Cupers continued by giving an overview of the priorities in life science research and development such as personalised medicine, the promotion of a healthy ageing of the population, the ICT in medicine and human bio-monitoring. He also stressed that the Commission is not only engaging with these challenges internally, but also by working with other non-EU countries such as the US, Australia or Canada through multilateral initiatives on specific types of research as in the cases of rare diseases or preparedness actions for research on emerging epidemics. The final aim of this approach is to enable European patients to profit from the best practices and interventions available and to create the most favourable environment for research and businesses.
Prof Bekaert focused on the academic side of the matter by underlining that academic institutions will not be able to contribute to winning the race individually. According to Prof Bekaert, academia are increasingly concentrating on streamlining its processes, making them more efficient and enhancing clinical trials assets. She also stated that, if, on the one hand, research centres are struggling to achieve these aims, on the other hand, they are also already making a difference and contributing to better research and development cooperation. She continued by pointing out that academic centres in Europe are generally working in a decentralised manner, while assets should be progressively shared between and among EU member states. She also stressed the fact that the academic world is at a crossroads and will be compelled to make some clear-cut choices by building on multidisciplinary expert centers and to avoid trying to cover as many sectors as possible when it comes to life science research. According to her view, building on specialised knowledge should reinforce cooperation between excellence centres and create the best conditions for the setup of virtuous collaborative networks. She concluded by stating that it would crucial to reconsider which value and evaluation standpoints the EU research and development should uphold, as well as to further analyse the outcomes of research and innovation projects on healthcare.
Mr Baetens approached the issue by elaborating on the relation between the capital markets and companies’ fundraising. According to Mr Baetens, particularly during this year, there has been an increasing number of life science companies using financial markets in Europe to fundraise. He also stated that the Capital Markets Union project is a significant political step towards a more vibrant economy. Nevertheless, he added that there are still challenges ahead concerning this aspect of research and development with special regard to both SMEs, which often rely only on financial markets in order to fund their activities, and investors, who need to perceive a favourable environment for this type of operation. In his view, the European equity and capital risk culture is less developed than in other parts of the world, such as the US. Mr Baetens added that this feature of the European economy has to be improved if the EU wants the life science industry to become more competitive and avoid an out- flow of talent and companies moving their headquarters to where conditions are more favourable. Mr Baetens concluded his intervention by highlighting that the main challenges on the horizon primarily consist of simplifying access to the capital markets and reducing the administrative costs for business.
Dr Meulien emphasised that the EU needs to connect its strengths while focusing more on multidisciplinarity, coordination, collaboration and integration processes. Dr Meulien firstly advocated more interfacing between different disciplines with special regard to the interaction between science and technology as a primary way to foster innovation in research and development. He also underlined the fact that this feature of research has already been successfully implemented in Europe’s academic sector. Subsequently, he stated that efficiency challenges of the EU pharmaceutical, despite its large budget, often consist of the fact that the EU industry is not delivering enough innovation as the arena is increasingly competitive and assessments are complex. In this connection, the lack of coordination is penalising Europe. This is the main reason why the Innovative Medicine Initiative (IMI) is strongly focusing on bringing the public and private sector closer together in order to accelerate the innovation processes. Finally he elaborated on the regulatory challenges and on the health technology assessment processes which are both inextricably linked to patients as the final component of the research and development chain. Dr Meulien stressed that patients need to perceive the economic interest of bringing innovation into their healthcare systems and stressed the fact that the value proposition of research and development projects has to be articulated in an understandable way for the final healthcare receiver.
A first point of the discussion concerned the efficiency of life science research and development activities as well as the EU regulatory standards and their effects on research and innovation processes.
Dr Cupers underlined that 90 percent of the resources and assets for research and development are in the hands of the member states. As a result, the European Commission consistently tries to also incite member states to collaborate (e.g. on research on neurodegenerative diseases). Regarding the EU regulatory challenges, Dr Cupers stressed the fact that there is a valuable quantity of funding and multidisciplinary projects whose results may serve as evidence-basis to support policies and regulations. Horizon 2020 societal challenge 1 is also attentive to involve all concerned stakeholders including regulatory actors as early as possible. For example, if the EU is willing to foster personalised medicine in the longterm, it will be necessary to further involve all actors, including Member States, citizens, patients and health-technology assessment authorities. Prof Bekaert reiterated the importance of more cooperation in the area of research and innovation and clinical trials to make sure that stakeholders build on common assets. In this regard, she highlighted the work of the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI), a uniform EU catalogue of individual phenotypes (patient samples and data) that enables the process of drug development, as an example of best practice. She also pointed out that there is a need to build consensus in order for the data collection processes to happen in a uniform manner. Prof Bekaert added that the regulation issue is a dilemma: while premising that she is in favour of regulations with regard to the highest ethical standard, she stated that finding a balance between reinforcing innovation and meeting the highest regulatory standards is often challenging. In this regard Dr Meulien stressed the fact that the European Medical Agency is very much aware of this dynamic. According to him, it is possible to respect the highest regulatory standards while accelerating time research and development in life science. Mr Baetens remarked that the regulatory environment is the highest barrier for SMEs which often do not find their way to the capital markets. After the financial crisis erupted, he highlighted the fact that there has been a tendency towards a “one size fits all” regulation mood. He continued by stating that many intermediates consider this as a risky dynamic. In this regard, he emphasised the existence of multilateral trading facilities, albeit insufficiently promoted, which are more suited for SMEs and provide a simpler access to the markets.
A second point of discussion focused on Intellectual Property Rights (IPRs) features and the assessments of the research processes.
Dr Meulien assessed IPRs as a very important topic as, without the right protection for industry players, there will be less investment. However, industry players also realised that it can be beneficial to forgo the intellectual property right during a pre-competitive phase in order to foster innovation. For this reason, IMI has now launched different projects free of intellectual property takings which enable pharmaceutical companies to work closely, share data and create knowledge in an accelerated way. Prof Bekaert regretted the fact that often the success parameters are linked to the number of patents without considering the value of the final result. For this reason, she remarked that there is a need to rethink how risk is shared between stakeholders. Moreover, in her opinion, the EU should reassess how collaborative success is evaluated as there is often excessive attention paid to the number of patents, spin offs and publications instead of the actual outcomes of the research and valorization process. True value should be re-evaluated, particularly in healthcare research. Dr Cupers acknowledged that there has been a past tendency to measure success by the number of patents, spin offs and publications, however, he remarked that European Commission also considers as very important the outputs generated by supported-research projects and their added value for citizens.
The final part of the debate and the Q&A session also covered the following issues: financing and midcap companies; Encouraging the role of citizens in healthcare innovation; How to evaluate the value of innovation; Funding and financing for more and more expensive drugs and the balance between more expensive medicines and declining healthcare budgets; Translational research and its impact on research and development; Assessment of the situation in other markets such as the US and China and predictive science.
Do you want to go further into the issues discussed in our debate? Check our list of selected sources which we have provided for you
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