Ready for Anything

The COVID-19 pandemic showed that Europe was ill-prepared to deal with health crises. Political indecision was compounded by shortages of essential medicines and equipment in 2020. Belgium’s Presidency is aiming to “enhance the EU’s health emergency preparedness and response governance framework,” with a focus on increasing the continent’s clinical trial capacity, negotiating an international pandemic treaty, and upping its work on fighting antimicrobial resistance (AMR).

Preparedness also covers securing the supply of essential medicine. There are aims to counter the recently-seen shortages of antibiotics and cheap generic drugs – much of the manufacturing for which has been outsourced to low-cost destinations in Asia over the past few decades due to cost concerns. To this end, this year, a ‘Critical Medicines Alliance’ will be created, identifying the most important drugs for which supply needs to be reinforced.

Additionally, there are hopes of luring more essential medicine manufacturing back to Europe via subsidies and boosting its “strategic autonomy.” Generics giant Sandoz for its part, opened a massive new antibiotics facility in Austria in November last year. In the opinion of Belgian Minister of Health Frank Vandenbroucke, “The fact that the Commission now considers the European production of older, basic medicines to be a matter of general public interest represents a complete paradigm shift and an important new milestone,” as reported by POLITICO last December.

While incentivising companies to produce low-margin products in a comparatively expensive European context will be a hard sell, a potential advantage for Europe in this push is its green credentials. Regulators, both in Europe and in global export markets, are increasingly stipulating more stringent environmental requirements for the pharmaceuticals they approve, something Europe is a global leader in. “Moving forward, we would like to see more state aid and mechanisms to incentivise companies to go even further on efficient, green, and digitalised production technologies,” said Elisabeth Stampa of Medicines for Europe – a Europe-wide generics industry lobby group – in a recent interview with PharmaBoardroom.

 

Unmet Needs

On the care front, in addition to heeding off shortages, the Belgian Presidency is touting “a needs-driven approach for innovation and health care policy to better address unmet needs.” Several Belgian stakeholders interviewed by PharmaBoardroom for our 2023 report on the country were already aligned on this topic and the importance of a collaborative approach in working towards it.

“All stakeholders need to orient their activity and investments towards unmet needs,” proclaimed Pedro Facon, deputy CEO of NIHDI, Belgium’s main social security institution. “We will bring this topic to the table during the EU Council presidency in 2024, as it needs to be reinforced.”

“Unmet medical needs will be on the agenda,” added Caroline Ven of industry association pharma.be. “This links into the wider agenda priority of greater European cooperation on health policy. As the pandemic showed, each country looking out solely for itself policy-wise is not a wise course. For this reason, vaccine contracts were negotiated at the European level, for example. Greater collaboration will be a priority.”

 

The EU Health Data Space

The Presidency is aiming to finalise the creation of an overarching EU Health Data Space (EHDS). The concept would allow patients’ (anonymised) data to be shared across the entire EU, creating huge opportunities for improvements from everything from primary patient care to clinical trial recruitment and national-level policymaking. It could prove a boon for clinical research in smaller European nations who would be able to access far larger patient datasets.

The parliament is hopeful of completing the project before the next EU elections in June, but significant barriers still exist. The most important of these is the fact that there is no harmonisation of the way that data is encrypted and processed across the EU, meaning that cross-border data sharing is challenging. This adds to concerns from patient groups and national governments about data safety and the ethical issues of sharing patient information with commercial entities such as pharmaceutical companies.

 

EU Pharma Reform

An even more problematic reform to push through will be regulation on the authorization and supervision of medicinal products for human use and governing rules for the European Medicines Agency.

Heavily criticised by the innovative pharma industry as a mortal threat to Europe’s global competitiveness, the reform would penalise companies that do not launch new drugs in all 27 EU member states simultaneously. Nathalie Moll of Europe-wide innovator association EFPIA called this proposal “fundamentally flawed” and “an impossible target for companies.” The generics industry as well as patient groups have however applauded the move, suggesting that it will prevent Big Pharma from patent gamesmanship and evergreening, allowing more Europeans to access more medicines.

The reform also includes propositions to reduce the window for which medicines’ intellectual property is protected, meaning the earlier introduction of generic copycats and potentially significantly reduced profits for originator firms. It seems unlikely that an agreement on this reform will be reached during the Belgian Presidency in the first half of 2024.