STRASBOURG – The European Parliament backed the EU’s Critical Medicines Act (CMA) on Tuesday in a decisive move to secure Europe’s pharmaceutical supply chains from geopolitical shocks.

With an overwhelming majority of 503 votes in favour, 57 against, and 108 abstentions, MEPs endorsed a sweeping industrial policy designed to re-shore the production of active ingredients (API’s), critical medicines and essential drugs like antibiotics and insulin.

While the vote marks a major step toward European “health sovereignty,” critics warn that the EU’s push for resilience could inadvertently drain global supply, drive up prices for essential drugs, and undercut Africa’s emerging pharma industry.

“The Critical Medicines Act is a bold step for Europe,” said Boniface Mbuthia, director of health financing at Amref Health Africa, in a statement to Health Policy Watch. “But its true success will be measured not only by securing EU resilience, but by its contribution to global health equity”. Amref Health Africa is the continent’s leading health NGO.

‘Buy European’ in response to US protectionism

The Critical Medicines Act, first proposed by the Commission in March 2025, aims to address the structural vulnerabilities that leave European patients facing empty pharmacy shelves. It complements the EU’s pharma act that was endorsed by European legislators in December, and is designed to boost the industry’s competitiveness.

To counter supply chain vulnerabilities, the Parliament’s position centres on “Strategic Projects” – industrial initiatives to modernise or build manufacturing capacity within the Union, supported by fast-tracked permits and state aid.

An exploratory study issued by the EU Commission found that over 50% of recent critical medicine shortages in the EU were caused by manufacturing issues, exacerbated by a heavy reliance on active pharmaceutical ingredients (APIs) from India and China. A medicine is considered critical if an insufficient supply results in serious harm or a risk of serious harm to patients.

Tomislav Sokol, the Parliament’s lead lawmaker responsible for drafting the bill, framed the legislation as a necessary response to an increasingly aggressive global trade environment, specifically citing pressure from the United States.

“The pharma industry is the strongest European exporting industry,” the representative of the conservative European People’s Party (EPP, Croatia) told reporters at a press conference following the parliament vote. “Unfortunately, Europe so far has not recognised this fact to the most significant extent, but US President Trump has.”

He warned that if the EU doesn’t bring back generic drug and API production capabilities, Europe faces a dual dependency: “We are currently to a large extent dependent on importing APIs and generic medicines from China. If we don’t do anything about this, we will add a new dependency on imports of innovative medicines from the US.”

Incentives to re-shore production capacities

A cornerstone of the Parliament’s proposal for the Critical Medicines Act is a reform of public procurement. Currently, national health systems often award contracts based solely on the lowest price, driving production to cheaper Asian markets.

The Parliament instead wants to mandate “Most Economically Advantageous Tender” (MEAT) criteria, prioritising security of supply and environmental sustainability.

Crucially, the Members of the European Parliament (MEPs) are pushing for preferential treatment of companies in public tenders whose “significant proportion” of production is located in the EU. “We define this as having at least 50% of the production of active ingredients or final products in Europe,” Sokol explained.

These measures are expected to raise drug prices, which will lead to heavier burdens on patients or national health budgets. Experts estimate price increases of 20%-40% for some critical medicines.

In an interview with Health Policy Watch, Tiemo Wölken, MEP for the Socialists and Democrats (S&D) and co-legislator, acknowledged this trade-off but defended it as essential for security.

“National and EU funds must be spent in the European Union. This means production must also happen in the European Union,” Wölken said.

“It has a higher value regarding security of supply because we make our own rules here. It is a bargain: money for access and security of supply,” he emphasised.

Industry pushback against joint procurement

While the pharmaceutical industry acknowledges the Critical Medicines Act as an opportunity to improve supply resilience, they insist that the final design must remain “proportionate, targeted and evidence-based”, the European Federation of Pharmaceutical Industries and Associations (EFPIA) explained in a statement.

“In order to successfully achieve its aim, the Critical Medicines Act needs to focus on real supply risks and practical solutions,” Nathalie Moll, Director General of EFPIA, summarised the association’s position.

A key concern addressed by EPFIA is the local-content consideration. The association argues that favouring procurement based on manufacturing location risks “weakening global supply diversification, reducing flexibility in supply chains and undermining Europe’s position as an export-oriented base for innovative medicines.”

While the Commission originally focused on industrial manufacturing capacity, the Parliament’s proposal to also include compounding activities within pharmacies or hospitals in the scope of manufacturing capacity measures has opened a new front of industry concern.

“This risks enabling stockpiling or broader use of unlicensed products, raising patient safety concerns and undermining public trust, as they are prepared on an ad-hoc basis,” EFPIA argues.

Notably, the industry continues to push back against the “scope and thresholds for joint and collaborative procurement,” warning that these elements risk diluting the Act’s original intent.

The Parliament voted on Tuesday to lower the threshold for activating joint procurement mechanisms from nine member states to five, making it easier for smaller countries to band together to negotiate prices.

Legislator Sokol was adamant: “I know for a fact that the industry is not really thrilled about the principle.” But he added that additional safeguards, such as binding quantities, will support the industry.

EU Parliament demands stockpiling

With the Parliament’s position adopted, the file now moves to trilogue negotiations with the Council and Commission before it can enter into force.

The pressure is on to finalise the regulation quickly, with Sokol hoping for a deal “within a couple of months,” citing the urgency of US protectionist trends.

A major point of contention in the upcoming negotiations will be the “Union coordination mechanism” for stockpiles. The Parliament wants to empower the Commission to order the redistribution of medicines from one Member State to another in cases of critical shortages.

“What we have now, unfortunately, is that national stockpiling in some Member States, especially the big ones, directly contributes to shortages in small Member States,” Sokol said.

He described the redistribution mechanism as a “last resort” to ensure European solidarity, acknowledging that it will likely face fierce opposition from national governments in the Council who view health as a sovereign competence.

The triple health threat to African countries

It is this very mechanism that is likely to cause issues on the global market, as Amref Health Africa points out.

The organisation has raised alarm bells regarding the Critical Medicines Act’s potential to disrupt the nascent pharmaceutical sovereignty of the African continent, pointing to three distinct risks:

• EU mandates to fill stockpiles could drain global markets of limited supplies, leaving African nations with shortages
• A massive spike in EU demand for APIs could drive up global commodity prices, making medicines unaffordable in the Global South
• By incentivising “made in Europe,” the EU may inadvertently undercut efforts to build pharmaceutical manufacturing hubs in Africa, an initiative heavily promoted by the African Union.

Without coordination, EU stockpiling could lead to “supply diversion,” reducing availability of medicines in African markets, warned Mbuthia, Amref’s director of health financing.

EU fails to consider Global South perspectives

Asked about these risks, the Social Democratic MEP Wölken insisted that safeguards are necessary. “We must ensure that European resilience is not bought at the cost of security of supply in the Global South,” the Social Democrat said. He referenced the COVID-19 pandemic, where export bans left the Global South waiting for vaccines, as a scenario the EU must avoid repeating.

However, he admitted that the instruments designed in the Act look particularly at the internal EU rather than at external relations. Specific implications for third countries were not the central topic of discussion, he said.

While the EU Commission had proposed a mechanism for international cooperation with preliminary expert reports underscoring the need for cooperation with African countries to diversify supply, the actual mechanism remains vague.

During Tuesday’s press conference, responding to a query by Health Policy Watch, Sokol clarified that the Parliament’s political compromise focused on EU candidate countries – such as those in the Western Balkans and Ukraine – rather than partners in Africa.

While partnerships with other nations are theoretically possible, some political groups felt broader inclusion was “exaggerated”, Sokol disclosed.

Focus on immediate neighbourhood part of Europe’s geopolitics

This focus on the “immediate neighbourhood” is part of Europe’s geopolitical ambitions and risks leaving African partners, identified by the Critical Medicines Alliance as key for diversification, out of the loop.

For stakeholders like Amref, the coming months will be critical to see if the final text includes explicit protections for global health equity, or if the EU’s drive for autonomy turns into a “Europe First” policy.

“We call on European policymakers to ensure that the Critical Medicines Act promotes cooperation, transparency, and shared resilience,” Ralph Achenbach, Executive Director at the German branch of Amref Health Africa emphasised.

It should be set up to be complementary to the African Union’s African Health Sovereignty initiative, Achenbach emphasised, supporting diversified manufacturing, investing in pharmaceutical production capacity on the continent, and strengthening equitable procurement mechanisms.

Image Credits: European Union/Emilie Gomez, European Union/Christophe Licoppe, European Commission, European Union/Alain Rolland, European Union/Christophe Licoppe, Amref Health Africa, Waldemar Salesski, Amref Health Africa Deutschland.