New EU medicines law aims to bypass India, China on key drugs – POLITICO

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The European Parliament had wanted medicines tenders to prioritize critical medicines with at least 50 percent of the product’s value made within the EU. The final compromise gives procuring bodies the option to prioritize EU-made products, with a sliding reward scale for medicines with a greater proportion of production in Europe.

The capitals had opposed a mandatory preference for EU products, since these medicines are expected to come with a significantly higher price tag. And with Europe’s public health systems already under budgetary pressure, higher drug prices will be hard to absorb.

Tiemo Wölken, Parliament’s negotiator with the socialists, told POLITICO after the deal: “Priority should always be given to manufacturers with the highest proportion of production located within the Union.”

Helping hand for home-made drugs

The text also establishes criteria for setting up so-called industrial “strategic projects” in the EU to create, modernize and increase manufacturing capacity for critical medicines. These projects can benefit from national or EU financial support, but they will have to comply with clear obligations, including prioritizing supply to the EU market.

In a win for the Parliament, EU legislators also agreed to include orphan medicines — which, unlike most critical medicines, are not cheap off-patent drugs but expensive innovative therapies to treat rare diseases — within the scope of the law. This will make them eligible for state aid as well as joint procurement, making them more affordable and accessible, especially for smaller EU countries.

On stockpiling, the final deal removed the EU’s mandatory redistribution of medicines from one country to another that is experiencing a shortage, as requested by the Parliament. But countries agreed to increase transparency over their contingency stocks.