The chief executive of one of the world’s biggest pharma groups has warned Europe may miss out on new drugs for conditions such as heart disease and cancer if it pushes ahead with “troubling” new legislation.
David Ricks, Eli Lilly’s chief executive, said under a draft plan to cut market exclusivity protection from 10 to eight years, it might not be worth the industry pursuing treatments for chronic diseases or cancer trials.
He added that investment in treatments for Alzheimer’s and obesity, where Eli Lilly has key potential medicines in its pipeline, would also be affected if generic drugmakers are allowed to create cheaper alternatives, earlier.
“If you think we have enough innovation or too much of it, then this subtraction idea will achieve that goal,” he told the Financial Times.
Decisions in Europe could also affect what pharmaceutical companies invest in globally, he added, because revenues generated in the EU, US and Japan fund innovation for patients around the world.
The EU has pushed back the publication of its first overhaul of laws governing the pharmaceutical industry for 20 years to the end of April at the earliest, giving some pharmaceutical executives hope that it could be reconsidering the reduction in intellectual property protection.
Ricks also said the reform would accelerate a decline in investment in the European pharmaceutical industry, compared to other countries such as the US.
“How can you create more BioNTechs?” he said, referring to the German biotech behind the breakthrough mRNA Covid-19 vaccine. “I think that is a question that should be more present in this legislation process.”
The draft law, seen by the FT, reduces the exclusivity period overall. But it rewards companies by offering them longer monopolies if they launch drugs across all EU member states within two years and if they conduct more extensive trials.
The European Commission is under pressure from smaller member states to ensure companies do not ignore their markets. Eight countries including Cyprus and Romania recently wrote a letter urging it to stick with the plan.
Health commissioner Stella Kyriakides told the European parliament in March that the “reform strikes a balance . . . fully supporting innovation and a globally competitive EU industry”.
“Medicines are not reaching patients quickly enough or at the same time. We intend to change this by rewarding those who go the extra mile to provide EU-wide access.”
But some in the industry say the proposals are impractical and that companies can take longer to launch a drug, for example, if a country is waiting to know what price others are paying.
“We have the same objectives but there are reasons that this doesn’t happen that have nothing to do with company will,” Ricks said.
Eli Lilly has made cuts in Europe and reduced the number of clinical trials there, he added.
But some campaigners for access to medicines welcomed the proposals. James Love, director of the non-profit Knowledge Ecology International, said Europe had the longest exclusivity period in the world.
Policymakers are putting pressure on pharmaceutical companies in many of their biggest markets, including reforms in the US that allow Medicare to negotiate the price of some drugs for the first time, and a sharp rise in the revenue clawback imposed by the UK government.
Ricks said there would be capital flight and job losses in the UK as costs for drugmakers rise. “The UK has a wonderful advertising campaign about attracting our industry. The reality is the opposite. Even their own home companies are investing massively outside the UK,” he said.
