Call for strategic regulatory rethink for EU generic medicines industry

“It is vital that costs associated with regulatory processes do not become a barrier to developing and improving generic and biosimilar products or even maintaining the product in the market,” stated Beata Stepniewska, deputy director general of the European Generic Medicines Association (EGA) at the 13th EGA Regulatory & Scientific Affairs Conference, held in London on January 23-24.

“The generic medicines industry must seize on opportunities in the current period of austerity to amend its way of thinking and push for significant changes to the regulatory environment,” Ms Stepniewska stressed.

There remains a huge potential for improving the European regulatory environment. Practical steps must include: streamlining the costs and processes of the variations procedures, simplifying the decentralized procedure, improving work-sharing as a core element of the EU regulatory network and assessing the impact of new legislation on both competent authorities and the industry, the EGA states.

Despite substantial pricing pressures, Europe remains the global hub for high quality generic and biosimilar medicines. The opening up of markets across the world has also encouraged the industry to think globally. Against this background, industry wants a single development process for products for multiple markets, it says.

Sector facing increasing regulatory costs

At the 7th EGA Pharmacovigilance Discussion Forum, on January 22, delegates heard that the industry is facing new fees for marketing authorization holders to be paid to the European Medicines Agency for new pharmacovigilance activities, while the fees of the National Competent Authorities remain in place or are even increasing. This creates the significant risk that the generic medicines industry will be forced to pay twice or even multiple times for medicines that are registered decentralized compared to centrally authorized medicines; additionally, to keep supplying the European market with generic medicines, manufacturers will also have to cover a 1 billion-euro ($1.37 billion) expense for the implementation of new safety features in the upcoming years.

At a time when profit margins are minimal, the sustainability of the industry is now under threat. Increased costs could lead to medicines being withdrawn from the market and even company closures subsequently leading to the end of competition.