Will a Critical Medicines Act get off the ground?

Written by David Gow, Senior Advisor

A majority of EU Member States have already expressed a fervent New Year’s wish: progress on their demand for a Critical Medicines Act (CMA) under the Belgian Council Presidency, that starts on January 1, 2024. They may well be disappointed.

There’s no doubt Brussels will be pushing it up the 2024 health agenda: they are lead authors of the germinal “non-paper” (Improving the security of medicines supply in Europe) on a CMA published on 2 May this year and co-signed by 18 other member states, including France, Germany, Italy and Spain.

What’s more, the relevant EPSCO Council Chair, Frank Vandenbroucke, Belgium’s deputy Prime Minister and the Minister of social affairs and public health, is the most prominent protagonist of a Critical Medicines Act  – and they believe they are making a compelling case. But they may be shaking their sunken head in frustration on 30 June 2024.

Health Commissioner in the outgoing College, Stella Kyriakides, has at best given an amber light to a CMA, saying that the proposal needs “further reflection” within the Commission. In late October the institution spelled out its current position: “a legislative initiative for an EU ‘Critical Medicines Act’ would require thorough preparation, including the assessment of economic aspects. The Commission will to that end launch a dedicated study, paving the way for an impact assessment. Concrete decisions on the need, content and feasibility of such an Act can only be taken when the evidence is available.”

There is an obvious need to take stock. The Covid pandemic – and disruption to global supply chains unleashed by it, along with the war in Ukraine inter alia, have brought a plethora of new EU legislation. In the public health field, this includes steps towards an unprecedented health union, including a beefed-up European Medicines Agency that now has powers to monitor medicines shortages and the new Health Emergency Preparedness and Response Authority (HERA) with powers to buy up drugs for the entire bloc. And, of course, the prolonged and highly contentious review – for the first time in 20 years – of pharma legislation. This all needs time to bed down.

The case for a Critical Medicines Act

Essentially, the case for a CMA follows the logic of the new Chips Act and Critical Raw Materials Act: on-/reshoring manufacture of key goods within Europe and much greater diversification of supply sources, alongside investment in targeted regions around the world. It is, in other words, another aspect of the Open Strategic Autonomy that has been the hallmark of the (first?) von der Leyen commission.

Specifically, Vandenbroucke and his confrères make three key points in favour of a CMA. It would: (i) reverse the trend of declining production of off-patent medicines in Europe; (ii) diversify pharmaceutical supply chains; (iii) secure some degree of strategic autonomy for certain critical medicines. He says the decline in European production – from over 50% of global output of APIs (Active Pharmaceutical Ingredients) in 2000 to just 25% two decades later, for instance – comes with consequences that are “increasingly problematic for European patients.”

In a pertinent note, the EU’s Economic and Social Committee points out that, with up to 80% of APIs used in Europe and 40% of medicines sold here coming from China and/or India, this growing dependence poses a potential public health threat in Member States. It urges specific investments to restore API production in Europe on a sufficient scale to ensure EU drug supply security. Further, it argues, reshoring would boost investment, jobs, and competitiveness while reducing costs.

Vandenbroucke highlights increasing security risks from dependencies and market monopolisation: “a new pandemic, natural disaster, (trade) war or even a manufacturing glitch could have disastrous consequences for the world’s medicines supply.”

The Belgian-led ‘non-paper’ says its three key proposals – for a voluntary solidarity mechanism to, temporarily and as a last resort, alleviate shortages in individual member states; a list of critical medicines and supply chains to be monitored; a CMA – are targeted at the short, medium and should be seen as complementary to other measures already in place or underway. There’s the rub.

Do we need yet more legislation?

The prevailing tendency in the EU is to address a “critical” issue by reaching for interventionist legislation to offset market failure and/or obviate national go-it-alone measures toxic to the single market. A Critical Medicines Act would be the default approach for many dealing with real or potential drug shortages but does that render it an impregnable case? After all, as the non-paper and other CMA proponents acknowledge, there’s plenty already in or being added to the EU toolbox.

The voluntary solidarity mechanism is on its way while a list of critical medicines, capturing 268 substances, was published on 14 December in a pre-Christmas move from the Commission that comes on top of several national ones. Similarly, a no doubt exhaustive report on supply chains is due in April 2024. There is already in place an array of legislative acts/regulations designed to promote re-/onshoring of manufacturing and a core aim of the pharma review underway is to make EU companies/industry more competitive and resilient in the face of external rivals.

What’s more, the commission has already proposed a Critical Medicines Alliance of industry, civil society and national/EU authorities “to be operational in early 2024”. This surely should be allowed to work before further legislation/regulation ties the industry up in ever tighter knots – undermining the very resilience the Commission claims it wants to boost.

So, our analysis suggests that there will be no rush to prepare for fresh legislation here. For one thing, the Commission cannot initiate it in its dying months albeit any preparatory work can continue. For another, so far shortages (such as of antibiotics) are not bursting their way into media headlines. We will have to wait until after the June 2024 European elections and the formation of a new Commission and Parliament to find out whether the proposed act will be forthcoming or not. Don’t hold your breath even then.