EFPIA warns EU reforms will hamstring pharma R&D

A trade organisation representing European pharmaceutical companies warned today that the European Commission’s proposed reforms to pharma legislation could result in the region losing a third of its share of global R&D by 2040.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has commissioned its own research, which claims the draft pharmaceutical legislation will have a detrimental effect on Europe’s competitiveness, as well as the life sciences sector and patient care.

Plans unveiled earlier this year included a proposal for the creation of a single market across the EU for medicines that would include penalties if a medicine is not made available across all member states within two years of approval, as well as a reduction in the number of years of market exclusivity for new medicines from 10 to eight years.

The proposals also aimed to reduce the administrative burden facing drug developers, by speeding up procedures and reducing authorisation times for medicines, so they reach patients more quickly. For example, the EMA will have 180 instead of 210 days to carry out reviews, and the Commission will have 46 instead of 67 days to decide on approvals.

EFPIA was quick to voice its objections when the proposals were first published in April and has now attempted to quantify their impact on the industry if implemented.

The trade organisation maintains that Europe’s share of global R&D investment is predicted to reduce by a third – from 32% of expenditure to 21% by 2040 – saying that is equivalent to €2 billion in lost R&D investments each year. Europe’s share already contracted from 37% in 2010, it points out.

Other findings of its assessment include that the Commission’s proposals to reduce regulatory data protection will reduce the incentive for companies to invest in these medicines by 55% in Europe over the next 15 years.

22% of projects to research and develop regulatory data protection (RDP) reliant medicines would no longer be economically viable in Europe, meaning that around 50 out of 225 expected new treatments over the next 15 years would be foregone.

Germany, Belgium, and France would be among the countries hit hardest, according to EFPIA, which estimates impacts of €626 million, €381 million, and €326 million, respectively. It would “hasten a trend which has seen Europe’s position as a global innovator deteriorate further in comparison to leading nations, the USA, China, and Japan.”

Small- and medium-sized enterprises (SMEs), mainly from Europe’s biotech sector, would also bear the brunt and accelerate a shift towards companies moving to areas with more predictable financial ecosystems in the US and China.

EFPIA president Lars Fruergaard Jorgensen, who is chief executive of Novo Nordisk, told Reuters that “everyone, going forwards, will start conducting trials in the US,” adding that in “some cases, they are not going to be developed in Europe.”

The measures currently being considered in the pharma legislation are “likely to harm, rather than strengthen, our joint ability to achieve these goals,” he said. “This will have a negative impact on the European economy, and most importantly on the lives of millions of people in Europe who need innovation in medicine to transform their lives.”

The European Commission insists that the plan will make sure medicines reach patients everywhere in Europe, in a timely and equitable fashion, and will create a “future-proof and crisis-resistant medicines regulatory system” with improved security of supply.