Proposed patent rule change could cause EU to lose access to crucial drugs, warns Eli Lilly
10 Apr 2023
Patent Expiration
The European Union risks losing access to key drugs for chronic diseases and cancer if proposed patent rule changes are implemented, Eli Lilly's CEO David Ricks told the Financial Times on Monday. The draft plan proposes cutting market exclusivity protection for drugs from 10 years to eight years.
The chief executive said the "troubling" decision could also affect investment in treatments for Alzheimer's and obesity if generic drugmakers were permitted to create cheaper alternatives earlier. Ricks noted that decisions made in Europe could impact what drugmakers invest in globally as revenues generated in the EU, United States and Japan fund innovation for patients worldwide.
Company executives are hopeful that the EU may be reconsidering its proposed reduction in intellectual property protection, as the publication of its first overhaul of laws governing the pharmaceutical industry for two decades has been delayed until the end of April at the earliest. The draft law is said to reduce the exclusivity period overall. However, it offers companies longer monopolies if they launch drugs across all EU member states within two years and conduct more extensive trials.
'EU-wide access'
Smaller member states are pressuring the European Commission to ensure companies do not ignore their markets. Eight nations, including Cyprus and Romania recently wrote a letter to the Commission, urging it to adhere to its plan. In March, health commissioner Stella Kyriakides told parliament that the "reform strikes a balance . . . fully supporting innovation and a globally competitive EU industry," adding that they intend to reward "those who go the extra mile to provide EU-wide access."
Meanwhile, certain members of the industry believe that the proposals are impractical, noting that firms can take longer to launch a drug if a country, for example, is waiting to know what price others are paying. Ricks argued that the reform would accelerate a decline in investment in the European pharmaceutical industry compared with other nations. He said Eli Lilly has already made cuts in Europe and reduced the amount of clinical trials conducted in the continent.
Pressure in other markets
Drugmakers are also facing pressure from policymakers in other markets, including reforms in the US that allow Medicare to negotiate the price of some drugs, as well as a significant increase in the revenue clawback imposed by the UK government. According to Ricks, there would be capital flight and job losses in the UK as costs for pharmaceutical companies grow.
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