Small and Medium Sized Biopharmaceutical Companies endorse further clinical data sharing but concerned about implementation as proposed.
European Biopharmaceutical Enterprises, EBE, a specialised group of European Federation of Pharmaceutical Industries and Associations, EFPIA, recognises the potential for scientific and public health benefits of providing greater access to information from clinical trials. Majority of EBE members are small and medium sized biopharmaceutical companies they share EFPIA’s concerns of which could put at risk the promotion of public health, both in Europe and internationally: risks of de-identification of patient data, sharing of companies’ commercially confidential information, and commercial consequences of secondary analysis of data for approved products.
￼“SMEs fear that certain measures suggested in the EMA draft policy could provoke consequences on their business models and impact on their ability to continue researching in what could become an insufficiently protected/regulated landscape” stated EBE President Roberto Gradnik.
Small product portfolios, limited specialised human resources, and fragile and delicate financial business models characterise these SMEs, which could be doubly struck by the proposed measures and their consequences. However fragile and delicate, the capacity of SMEs to participate in Europe’s growth, health and science is major. It is therefore crucial to preserve these business models and do not jeopardise their growth capacities at stake because of disproportionate administrative requirements.
EBE members are particularly concerned about potential incurred impact of specific measures on biopharmaceutical SMEs: (further details on EBE’s Position Paper)
- Disproportionate additional financial and human resources are required to implement the policy.
- Definition of Commercially confidential information and its availability to public.
- Impact by the risk of de-identification of single patient data in small patient populations e.g. in orphan diseases.
Beyond the logistical and technical issues raised by the policy, EBE believes that it would be appropriate to evaluate the consequences for the SME funding model. “Regulatory policy should preserve SME competitiveness in Europe, not destroy it. European legislative framework for medicinal products is essential to ensure a high level of public health protection and to stimulate a dynamic environment for continued research” Stated by Titta Rosvall-Puplett, Executive Director EBE.
EBE believes that these issues should be properly-evaluated prior to introduction of the policy, and suggests impact assessment exercise, which would have been a necessary part of the policy process had the proposal been introduced by the EU institutions.
The European Biopharmaceutical Enterprises (EBE) is the European trade association that represents biopharmaceutical companies of all sizes operating in Europe. It has 50 member companies – majority of which are small and medium sized companies – engaged in the research, development, manufacturing and marketing of new medicinal products using biotechnology. EBE also operates as the biotechnology arm of EFPIA, the European pharmaceutical industry federation.
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