The European Generic medicines Association (EGA) and its European Biosimilars Group (EBG) welcome the publication of a consensus information document on biosimilar medicines on the European Commission website. It is the result of extensive collaboration of a multi-stakeholder subgroup formed by volunteers from EPF, CPME, ESIP, AIM, EGA, EFPIA, EuropaBIO and EU Member States. The EGA is confident that the documents will provide further assurance that European Commission approved biosimilar medicinal products are of high quality and as safe and efficacious as their originator reference products. The EGA calls now on Member States to roll out this consensus information document in their national jurisdictions and to further develop the necessary conditions for an informed uptake and adequate patient access to these high quality biopharmaceuticals. “This is in the interest of public health and the sustainability of the EU healthcare systems”, said Beata Stepniewska, EGA Acting Director General.
Under the project of corporate social responsibility in the field of pharmaceuticals, the Steering group on Transparency and Ethics developed a List of Guiding Principles Promoting Good Governance in the Pharmaceutical Sector which was endorsed at the group’s meeting of November 2012 in Cyprus. The EGA is working closely with its national associations to implement and promote the Guiding Principles, principles which are already integrated in the core values and business practices of the generic medicines firms represented by the EGA. “We trust that the implementation of these guiding principles will contribute to the elimination of misinformation campaigns against generic and biosimilar medicines and to reinforcing patient confidence in the pharmaceutical industry, in healthcare professionals, and in competent authorities.” Beata Stepniewska commented. The EGA surveys its members on a regular basis to compile cases of misinformation on generic and biosimilar medicines in Europe and is constantly striving to denounce such unfair practices. “It is clear that these practices, such as the recent articles published in the French press, are still on-going, creating confusion amongst patients and healthcare professionals. It is essential that the work of the Ethics and Transparency Platform tackles misinformation campaigns which target the general public on generic and biosimilar medicines.” Beata Stepniewska said.
With its objective of improving access to affordable medicines for all EU citizens, wherever they live, the EGA is also actively involved in the project of improving the supply of medicines to small countries. These smaller markets with low volume sales particularly suffer from availability of lower priced products in the treatment of severe and/or rare diseases. The EGA members strongly advocate for a holistic approach, removing regulatory barriers to create incentives for the industry to bring medicinal products to these markets.