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Germany clashes with other EU states over pharma regulation overhaul

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Germany and several smaller member states have resisted last-ditch lobbying efforts on EU pharmaceutical legislation to be published next week, with Berlin warning it would hurt investment by the pharmaceutical industry.

The overhaul of pharma law is the most significant for 20 years, prompting an outcry from drugmakers who fear the EU will cut exclusivity protection from 10 to eight years, while allowing them to win back two years by jumping over new hurdles Will be

In a position paper seen by the Financial Times, Berlin argues that the EU should be “innovation-friendly”, and that the drugs should be launched in all member states within two years to gain an extra year of market exclusivity. Need to do, “considerable risk” “to the industry.

The German paper echoes concerns raised by the pharmaceutical industry, which has argued that national pricing negotiations that are beyond its control often block launches across the bloc.

The German government said drugmakers cannot count on getting an extra year before generic drugs are allowed on the market, making it “very difficult” to predict whether their costs can be recouped.

“Such uncertainty could then lead to a significant reduction in investment,” it said. The German government declined to comment.

But a second paper sent to the commission, backed by six states including Austria, the Netherlands, Poland and Slovakia, was also seen by the FT, Argue that the current system does not meet EU citizens’ human rights to access innovative treatments.

They say EU incentives for drugmakers are “quite lavish” compared to other countries including the US and China, and support a scheme of incentives that links intellectual property protection to health priorities.

“We urge the European Commission to move towards a patient-centred approach. Such an approach should specifically reward medicines that meet an unmet medical need and, at the same time, availability, access and affordability improve the balance between

Germans have more drugs than citizens of other member states and its large market increases its purchasing power.

Similarly, 92 percent of innovative drugs are available in Germany, but less than 30 percent in smaller and former communist states, according to research by FFPA, which represents the pharmaceutical industry.

Brussels wants to force drugmakers to cut deals with them at lower prices or risk losing market share to generic drugmakers.

Despite being praised for developing vaccines at a record pace during the pandemic, the pharmaceutical industry has been under political pressure. In the US, last year’s Inflation Reduction Act allowed the public health insurance program, Medicare, to negotiate drug prices for pensioners for the first time. In the UK, drug manufacturers have denounced a sharp increase in tax on drugs sold to the NHS.

This month, the chief executive of Eli Lilly, one of the world’s biggest pharma groups, warned that Europe could miss out on new drugs for conditions such as heart disease and cancer if it goes ahead with exclusivity cuts.

The draft law, which could be amended by the Council of Member States and the European Parliament, is expected on April 26 after weeks of delays.

Health Commissioner Stella Kyriakides told parliament this week it was on track despite speculation of further postponements.

The European Commission said it would “put forward a balanced and patient-centred proposal, while fully supporting an innovative and competitive industry”.

Additional reporting by Donato Paolo Mancini in London and Laura Pittel in Berlin