The European Commission proposed the biggest overhaul of European Union pharmaceutical legislation in two decades on Wednesday, in a bid to improve access to medicines and encourage research into neglected treatments.
Pharmaceutical companies will be granted eight years of regulatory protection to sell new medicines as a default – a cut to the maximum of 11 years offered currently, but with additional years offered as incentives for companies that take certain steps to widen the availability of medicines and provide treatments for neglected conditions.
The European commissioner for health Stella Kyriakides used a quote she attributed to U2 frontman Bono as she launched the reforms, declaring: “Where you live should not determine whether you live or die.”
Inequality in access to medicines between European Union (EU) member states is at the heart of what the reforms attempt to address, because the commercial interests of pharmaceutical companies mean that medicines become available to patients in larger and wealthier markets like Germany before smaller EU member states with less purchasing power.
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“Citizens in the EU cannot be first and second class citizens when it comes to accessing medicines in the EU,” Ms Kyriakides said.
“There are EU citizens who have to wait anywhere from four months to two to three years for some of these medicines, and this is truly unacceptable.”
The new system of incentives proposed by the commission is an attempt to address shortcomings that have emerged where the profit motive is insufficient or counterproductive.
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Pharmaceutical firms that launch medicines in all member states will be granted two extra years of regulatory protection, which means that rivals developing generic alternatives cannot get regulatory approval from the European Medicines Agency (EMA) if they refer to the original company’s trial data in their application.
An additional year is offered if a medicine is approved to treat an additional condition, a six-months bonus is available if the medicine addresses “unmet medical needs”, and another six months can be granted for comparative trials.
The proposals were shaped by the lessons of the Covid-19 pandemic, which underscored shortcomings in supply chains and the availability of medicines.
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Under the plans the EMA would permanently adopt the “rolling review” system that was developed to speed up the approval of Covid-19 vaccines as part of efforts to streamline the system. This involves regulators examining trial data as it becomes available, rather than waiting to assess a single submission once all trials have concluded.
Procedures would be digitalised and streamlined, with reductions of the paperwork needed to get approval for certain medicines for new uses.
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Part of the package is a plan to reduce the over-use of antibiotics to try to decrease antimicrobial resistance, with a target to reduce their consumption by 20 per cent.
As an incentive, companies that develop new antimicrobials can be awarded a “transferable data-exclusivity voucher”, which would grant an additional year of regulatory data protection for any medicine, and can be sold or traded to other firms. It’s an idea that has been received with caution by some member states.
Unequal coverage particularly affects countries in the east of Europe, which have access to just 10 per cent of newly-approved medicines, compared to the 90 per cent that are available to patients in western Europe, according to the European Commission.
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The proposals were repeatedly delayed in advance their launch as the pharmaceutical industry pushed for their intellectual property rights not to be undermined, arguing that this would counterproductively remove their incentive to fund the research for new medical treatments.
Members of the European Parliament and patient advocate groups meanwhile pushed the commission for a tougher stance, including penalties on pharmaceutical companies that do not alert national authorities when they plan to stop production of a medicine, and for the release of data on how much their research and development operations really cost.
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The proposals must now be considered by the EU member states and by the parliament, and there are concerns that there may not be time to approve it before European elections next year, and the end to the terms of the current commission and parliament.
