Thursday, May 19, 2016 - 18:16
On 19.03.2014, the European Generic Medicines Association (EGA), whose member is BGPharmA, carried out its tenth annual Legal Affairs Forum and appealed to the EU to remove the obstacles to competition and free trade on pharmaceuticals markets by implementation of reasonable reforms regarding intellectual property rules in the pharmaceutical sector.
Improving the effectiveness of patent protection
To ensure the access of generic and biosimilar medicines to markets with expired patent protection of the original product, it is necessary to improve the quality of patent assessment and mostly, to strengthen the application of criteria of the so-called "inventive step". Lydia Malo, IP Manager in EGA, stated that the European Generic Medicines Association is engaged in a constructive dialogue with the European Patent Office to prevent misuse of pharmaceutical patents, so that the competition on the Single European Market is not obstructed. EGA believes also that any decisions which obstruct the entering of generic medicines on the market after patent expiration of the original product should be valid only after judicial confirmation.
Stimulating the export to boost growth and employment in Europe
EGA underlined to the EU also the necessity of modification of the Supplementary Protection Certificate (SPC), so the manufacturers of generic and biosimilar medicines could export to developing markets where SPC was not applied. According to Adrien van den Hoven, Director General of EGA, Europe is a competitive place for high-technology manufacturers. SPC wrongfully blocks the export of generic medicines to other parts of the world which imposes the European Commission to act promptly in order to overcome this restriction.
Clarification of patent policy
EGA is concerned regarding the effect of European Commission policy in the field of patient rights which could result in restricting the possibility of generic medicines manufacturers to litigate patents. High-risk patent policy and the unclear situation in Europe regarding patents leads to the necessity of more directions given by the European Commission to the generic industry about the issues permitted in settling patent rights.