Higher Costs, Higher Fees, Higher Drug Prices: The UK No-Deal Brexit Bonus
A freestanding UK Medicines and Healthcare products Regulatory Agency with a dedicated authorization route for new drugs OKd by the European Medicines Agency and national incentives for pediatric and orphan drug development are just some of the likely outcomes of a no-deal Brexit as described in a consultation document just released by the government. In many cases companies will end up paying again for services they currently receive from the EMA, and, the government says, they may pass these extra costs onto the national health service in the form of higher prices.
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Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.
Plans for a post-Brexit standalone regulatory system have drawn a mixed response from UK pharmaceutical industry bodies, which are worried about aspects of proposals on future drug approval routes, orphan and pediatric drug incentive schemes, and the “grandfathering” of existing EU marketing authorizations. They are also calling for financial compensation should the UK not be part of Europe's the new drug verification system.
It is being suggested that a no-deal Brexit would put an end to parallel imports to the UK, thereby reducing price competition and pushing up costs of medicines prescribed on the NHS.