Dutch health minister backs Critical Medicines Act, says full implications being assessed
Source: Euractiv
Dutch Health Minister Fleur Agema (PVV) is preparing a detailed analysis of the potential of the Critical Medicines Act (CMA). A spokesperson for Agema told Euractiv that the minister welcomes the European Commission’s proposal for a regulation to improve the availability of critical medicines in the EU.
They added however that the Health Ministry will be carefully studying the proposal before the Minister can provide a more detailed analysis of the CMA.
Published by the European Commission on 11 March, the CMA aims to improve the availability, supply and production of critical medicines within the EU. These include drugs for which limited, or no alternatives exist, meaning that a supply shortage could lead to patients being seriously harmed.
The Commission said it hopes to increase the EU’s manufacturing of critical medicines and to incentivise the diversification of supply chains.
“It is too early to already comment on the impact of the CMA and what can be improved. A detailed appreciation will be published within two months,” the Dutch spokesperson said.
Asked whether the Netherlands would be able to support the EU to lessen its dependency on external countries for manufacturing drugs, the spokesperson explained they already financially support one manufacturer to innovate and upscale their production process for a select number of generic medicines.
“This means that these medicines will again be manufactured in the Netherlands but with new technology which makes the production more efficient and sustainable,” they said. With its detailed review of the CMA, the Ministry will also assess the role the Dutch manufacturing base can play.
‘Manufacturing problems leading to shortages’
The CMA is providing some countries, including Greece and Lithuania, with the hope that the new rules could ease medicine shortages – a common theme across the EU.
Similarly, in the Netherlands, the Medicines Evaluation Board (CBG), which authorises the entry of medicines into the market, hopes the CMA will contribute to reducing vulnerabilities in supply chains and improving the availability of critical medications.
A spokesperson for the CBG told Euractiv that the board knows that manufacturing problems are often the cause of shortages and that they have seen an increase in problems in factories in recent years.
“As a regulatory authority, we see the vulnerabilities in the availability of alternative medicines and in supply chains, but we have no influence on procurement processes and pricing policies or industrial policy,” the CBG spokesperson said.
For now, the CBG is exchanging information with other EU member states and can request stock redistribution through a solidarity mechanism.
Patient perspective needed
Meanwhile, Health Action International (HAI), an Amsterdam-based organisation that works towards equitable access to affordable medicines, said there was a need for action at the legislative, regulatory, and manufacturing levels to counter the growing challenge of medicine shortages in the EU.
While also welcoming the initiative, HAI said medicine shortages should be addressed from a public health perspective with the welfare of patients at the centre.
“The Critical Medicines Act should not be framed as part of an industrial policy nor as a component of any defence strategy, as recently floated in an op-ed from a group of EU health ministers,” HAI Senior Policy Advisor Jaume Vidal told Euractiv.
The letter, signed by 11 health ministers, called for drug shortage plans to be funded by the EU’s new defence funds. The Dutch health minister was not one of the signatories.
Ending dependence on China, India
HAI said one of the CMA’s goals is to put an end to the EU’s dependence on India and China for medicines and their active ingredients. It said this trend expanded in the last decade with pharmaceutical companies offshoring their production, an issue highlighted during the COVID-19 pandemic.
“While we believe that promoting local production of pharmaceuticals might in the long-term benefit patients and societies at large, we must be vigilant and ensure this does not happen at the expense of labour conditions or environmental requirements, which play a big role in pharmaceutical companies moving production elsewhere,” Vidal said.
The European Commission said that a key feature of its proposed CMA is collaborative procurement among different member states. The purpose is to address the availability and access disparities of critical medicines and other medicines of common interest.
Vidal said that HAI has consistently asked market authorisation holders to be bound to market their products in all EU member states and not only in the most lucrative markets.
“A possible option would be to use the Critical Medicines List mentioned in the proposal by the Commission as a common threshold to be available in all EU member states with 6-month stocks and commitment by market authorisation holders and licensees to ensure supply,” Vidal said, adding, “Companies in breach should face fines.”
Vidal remarked that HAI is part of the Public Pharma for Europe (PPfE) Coalition, which seeks to set up a public pharmaceutical manufacturing entity that would encompass R&D, manufacturing, and supply and will be guided by health needs rather than market-driven.
“We believe that it would be a good option to respond to such so-called market failures, including medicine shortages or lack of effective antibiotics, which can be linked in fact to shortcomings of the current pharmaceutical business model,” Vidal said.
[Edited by Vasiliki Angouridi, Brian Maguire]
The original article: belongs to Euractiv .
