Improvements to the EU regulatory environment
25/1/2011 - Improvements to the EU regulatory environment will increase patient access to generic and biosimilar medicines and enhance competitiveness and competition
"The EU regulatory environment needs to be optimised in order to deal with the growing demand for generic and biosimilar medicines. These medicines, which are now front-line treatments for a whole range of chronic diseases and account for nearly 50% of all medicines dispensed to European patients are the key to healthcare sustainability in the EU and the European regulatory system needs to reflect this reality." This was the key message of Greg Perry, Director General of the European Generic medicines Association (EGA), as he presented the association’s Vision 2015 at the EGA’s 10th Regulatory and Scientific Affairs Conference, held in London today.
The EGA Vision 2015 puts forward a series of proposals to improve the regulatory and legal framework for the registration of medicines. These are based on the following five objectives:
- enhancing the competitiveness of the EU generic and biosimilar medicines industry by introducing a broader interpretation of the EU reference product so as to reduce the unnecessary repetition of clinical studies, and by ensuring that the current, high-quality safety and efficacy standards in the EU for generic and biosimilar medicines are applied globally;
- maintaining pharmaceutical competition and sustainable healthcare by preventing anti-competitive strategies aimed at delaying the entry of affordable generic and biosimilar medicines;
- improving patient access to affordable medicines through better regulation by streamlining the decentralised procedure, improving generic medicines access to the centralised procedure, reducing bureaucracy and adopting a homogenous and consistent implementation of the revised EU bioequivalence guideline;
- reinforcing regulatory harmonisation by removing country-specific requirements, ensuring efficient use of resources, improving mutual recognition, and optimising work-sharing across Member States;
- providing patients with necessary and appropriate information by encouraging EU medicines agencies to devote website space to information on generic and biosimilar medicines and by preventing negative campaigns against generic and biosimilar medicines.
Today, generic medicines, which save over €30 billion annually for EU health systems, already account for 80% of registrations under the EU decentralised procedure and are reaching nearly 50% of applications under the centralised procedure. Greg Perry stressed that "registrations for generic and biosimilar medicines are set to increase further as patents expire on many blockbusters medicines and governments seek to increase access to generic and biosimilar medicines".
At the previous day’s 4th EGA Pharmacovigilance Discussion Forum, the EGA welcomed the new pharmacovigilance legislation as "it takes into account patients’ expectations and is science- and risk-based driven”. Suzette Kox, Senior Director Scientific Affairs at the EGA stressed that "a proper and harmonised implementation by the Member States will be crucial in order to meet the initial objectives of the European Commission proposals to rationalise and strengthen the EU pharmacovigilance system. Guidance for interpretation and European Commission implementing measures are now eagerly awaited. The legislative changes will be far reaching and to be fully and effectively implemented, they need increased resources at all levels” Ms Kox said.
