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HomeBreaking NewsEU Pharmaceutical Reform Is No Cure-All

EU Pharmaceutical Reform Is No Cure-All

'Quick read' news summary

Imagine being denied life-saving medical treatment because you live in the wrong country.

It’s a chilling thought, yet it happens to Europeans every day. Patients’ access to the latest medicines varies greatly among EU members, and the health consequences are often grave.

The European Commission is seeking to fix this problem. It is drawing up a proposal for consideration by the European parliament. But the Commission’s own Regulatory Scrutiny Board just reportedly rejected the first draft, because the proposed changes would impede medical innovation.

Sadly, the oversight board is right. The proposal, while well-intentioned, needs an overhaul.

The European Medicines Agency is one of the most stringent drug regulatory bodies in the world. One might assume that, once the EMA approves a drug, it quickly becomes available across all EU 27 member states.

But this isn’t the case. For instance, Germans have access to 88% of all EMA-approved medicines, according to a 2021 report by the analytics firm IQVIA. In my country, the Czech Republic, patients must make do with 57% of those drugs. In Latvia, just 15% are available.

When the European Commission announced its sweeping Pharmaceutical Strategy for Europe in 2020, rectifying these inequities was a chief goal. This year’s EU legislative update is supposed to be the latest step in the strategy.

Equalizing access is important. But the Commission’s current approach goes about it the wrong way — by cutting back on intellectual property protection for drug developers.

Under current EU rules, certain medications enjoy a 10-year period of “market exclusivity.” During that time, rival companies can’t launch a competing generic drug.

The Commission’s proposal would cut that period back to eight years, but with a catch: Drug makers would be able to regain those two lost years of exclusivity by making their new wares available in all 27 member-states within two years of EMA

Imagine being denied life-saving medical treatment because you live in the wrong country. Patients’ access to the latest medicines varies greatly among EU members, and the health consequences are often grave. But the Commission’s current approach goes about it the wrong way — by cutting back on intellectual property protection for drug developers.

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