Politics Matters
Politics Matters
Politics Matters is an independent, boutique, government affairs firm in Brussels, Belgium.
ID: 284048119122-32
Lobbying Activity
Response to Pharmaceutical Strategy - Timely patient access to affordable medicines
7 Jul 2020
Valneva welcomes the Roadmap for a Pharmaceutical Strategy for Europe (PSE) that was published by the European Commission on 2 June 2020. The current COVID-19 pandemic has exposed the imminent need for European institutions to profoundly change the approach towards European manufacturers of pharmaceutical products and their related research and development investments.
Valneva is a European vaccine manufacturer with its core R&D as well as production facilities all located in Europe. The company is a European mid-sized specialty vaccine manufacturer providing prevention against diseases with major unmet medical needs. The company currently conducts late-stage clinical trials on vaccine candidates against the Lyme disease and Chikungunya. Moreover, the company has also commenced with research and development of an inactivated vaccine candidate against COVID-19.
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Valneva strongly supports the European Commission’s intentions to (re-)establish pharmaceutical manufacturing autonomy in Europe. However, vaccine research and development manufacturers, that are located in Europe, are confronted with a number of challenges.
1. Mid-sized vaccine manufacturers are particularly interested receiving financial support for late-stage research. Too often too many medical products receive European funding for the initial research stage, but phase II and/or III of clinical trials (the costliest) are rarely subsidized under the current European programs. This is precisely where European health research funding can make a difference and become more attractive for European pharmaceutical research in order to regain/maintain its presence in Europe.
2. Such funding support shall be construed under a direct and competitive bidding nature, allowing companies to benefit directly and avoiding as much as possible administrative burdens. Currently health research funding programs (Horizon 2020 and Horizon Europe) in Europe are almost exclusively organized along consortia driven approaches. Smaller biotech companies, such as Valneva, once they would comply with the stringent conditions, do not have sufficient (human) resources to participate at such larger consortia-driven research tenders, that too often focus on early-stage rather than late stage research.
3. Currently provisions to participate in EU health research funding are too stringent for mid-sized research companies. In order to foster and attract (again) European health technology in Europe, it will be essential that research is sufficiently supported. The current lacking of any clear definition for mid-sized companies, such as Valneva, to participate into health research funding projects is not at all helpful. Moreover, while establishing a true European pharmaceutical industry, it will be equally important taking into account the benefits and contributions such companies are bringing to the European market.
4. Valneva is very much committed to cooperate closely with public health authorities. In areas of unmet medical needs, such as the fight against the Lyme disease, the company has a vast knowledge about the prevalence as well as early diagnosis of the disease. In order to be successful, it is paramount for European competent authorities to recognize there is a broad and often unique expertise present in Europe. It is unfortunate that the ECDC’s current mandate apparently does not allow a cooperation with industry during the research stages of a novel vaccine candidate against the Lyme disease. This should be remediated in the upcoming Pharmaceutical Strategy for Europe.
Read full responseMeeting with Jorge Pinto Antunes (Cabinet of Commissioner Janusz Wojciechowski)
11 May 2020 · Smart farming