December 8 2017

Danish Health Minister Ellen Trane Nørby called on the European Commission on December 8th to draft a detailed vision for access to medicines in the EU

Trane Nørby’s call for “a political document” with guidelines for “specific actions” came as health ministers and national ambassadors meeting at the Health Council in Brussels discussed the issues creating a shortage of medicines across the EU: the high price of some innovative drugs; the withdrawal of some medicines (such as in Greece) because drugmakers consider those markets unprofitable; and the parallel export of medicines.

Slovakia, for example, said it has problems with the price of innovative medicines and is preparing legal changes to help patients obtain them, though the Slovak representative did not provide details. Greek Health Minister Andreas Xanthos shared the problem he has faced with Roche trying to withdraw its cancer drug Cottelic from the country’s reimbursement list because of a newly imposed discount. And Romania and Slovenia called for changes to a 2001 EU law on the supply of medicines that would clarify the obligation of drugmakers and wholesalers to ensure a sufficient supply of medicines in one country before exporting to EU countries where the same drug is sold for a higher price.

EU Health Commissioner Vytenis Andriukaitis said he will analyze the Danish request and see how to move forward. Given the varying reasons driving difficulties in patients’ access to medicines, “we need to discuss these issues in a more systematic way,” he said. Andriukaitis is not, however, willing to revise the law on the supply of medicines in relation to parallel exports.

Some countries advocated for restraint in changing EU laws that regulate medicines development and supply in the EU.

The availability of medicines is a very complex issue; we have to look at how to ensure security of supply for innovative medicines, while guaranteeing their development,” said Annette Widmann-Mauz, German parliamentary state secretary. And the U.K.’s Parliamentary Under Secretary of State James O’Shaughnessy said the EU “must ensure that the current system of intellectual property is not undermined” in a way that would discourage medicines innovation from taking place.

Many EU countries asked to wait for ongoing studies on IP incentives for pharma to be released by the Commission before deciding whether any legal changes are needed. The studies were requested by the Dutch presidency of the Council in conclusions adopted in June 2016.

Andriukaitis said one study on IP incentives and access to medicines is expected to be finalized in the first two months of 2018.


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