Euro Roundup: Commission proposes Critical Medicines Act, receives pushback from industry
Roundups | 13 March 2025 |
The European Commission has published its proposal for the Critical Medicines Act. Officials hailed their support for collaborative procurement as a way to “address availability and access disparities” but the lobby group EFPIA warned the option “could create more harm” than a permanent solution.
In recent months, the Commission has collected and reviewed feedback on how to address supply chain vulnerabilities and reduce the European Union’s dependency on other countries. The goal is to bolster the supply of critical medicines and improve the availability of other drugs of common interest. With the consultation now closed, the Commission has published the Act.
The goals of the Act include using the aggregated demand of EU member states through collaborative procurement procedures. In a Q&A on the proposals, the Commission said the Act provides a framework for member states to request its “support in using different collaborative procurement tools for critical medicines and other medicines of common interest, under certain conditions.”
There are three options to carry out the work. The Commission can support cross-border procurement between member states, procure certain medicines for member states or voluntarily work with member states in joint procurement. Procurement “would always be voluntary and in respect of the principles of subsidiarity and proportionality,” the Commission said.
Pharma trade group EFPIA said it “welcomes the efforts to introduce criteria beyond price for the public procurement of critical medicines” but raised concerns with the inclusion of strengthened collaborative procurement options.
The options “may be appropriate under very specific circumstances where they accelerate patient access to critical medicines,” EFPIA said, but “a systematic application could create more harm than offering a more permanent solution to access related issues.” The trade group said clarity is needed to identify “circumstances where collaborative procurement options would improve access beyond existing national pricing and reimbursement pathways.”
EFPIA also commented on the Commission’s planned approach to the contingency stock requirements imposed by some EU countries. The Act warns national stockpiles “can have a serious negative impact on the internal market and other member states.” To avoid that outcome, the Commission said contingency stock obligations should consider the principles of proportionality, transparency and solidarity.
The Commission is preparing guidelines intended to stop the scope and timing of national stockpiling requirements from harming the internal market. EFPIA said “the Act needs to go further and provide an effective response to fragmented national contingency stock requirements that disrupt the functionality of the single market.”
Medicines for Europe, a trade group for off-patent drugmakers, also commented on contingency stocks. The organization wants legislators to support “more EU solidarity on strategic EU reserves and national stockpiling mandates to ensure that patient access to medicines takes precedence over hoarding in the event of a medicine shortage.” Medicines for Europe called the Act a “major milestone.”
Press release, Commission Q&A, EFPIA statement
EMA finalizes updated guidelines on clinical trials of depression, epileptic disorder drugs
The European Medicines Agency (EMA) has finalized guidelines on the clinical investigation of depression and epileptic disorder drugs.
EMA released draft versions of the documents for consultation in 2023. The agency has kept most of the draft wording of both guidelines while still making significant additions and deletions of text. Changes include the addition of new advice on clinical trials of psychedelics to treat depression, a topic that is completely absent from the guidance EMA published in 2013.
After the consultation, EMA added more advice on expectancy and unblinding in psychedelic trials. The final guidance says it is “particularly important to assess and report success of blinding with appropriate methods, predefined in the trial protocol.” EMA shared details on how to mitigate the potential for participants’ awareness of whether they received the study drug or placebo to influence their response.
“An effective strategy might involve systematically assessing participants' awareness of their treatment allocation to ensure the reliability of blinding,” EMA said. “Conducting trials with different designs, e.g. offering open label treatment after the double-blind placebo-controlled phase for those in the control group or including different doses (low, middle and high) without placebo could help addressing these challenges and provide complementary information to estimate the nocebo effect.”
Changes to the epilepsy guideline include the removal of a line about the need to justify “the underlying assumption that the seizure risk within a patient is constant over time” and the addition of text about alternative methods for assessing efficacy. The agency said sponsors could measure “seizure free days in patient diaries, particularly for those seizure types that do not occur frequently enough on prolonged EEG recordings, for patients who cannot fully cooperate with prolonged EEG monitoring.”
Depression guideline, Epilepsy guideline
MHRA removes indication from prolonged-release opioid label over safety concerns
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has removed postoperative pain from the approved indications of all prolonged-release opioids.
MHRA’s Commission on Human Medicines found using prolonged-release opioids to treat pain after an operation may raise the risk of breathing difficulties and persistent use or dependence on the drugs. The risks in postoperative patients outweigh the risks, MHRA concluded. That position led the agency to axe the indication from the licenses of modified-release morphine and oxycodone products.
Morphine and oxycodone were the only prolonged-release opioids previously recommended for acute postoperative pain relief. MHRA is adding warnings about the adverse events to the product information for all modified-release opioids.
The agency also noted that patients may be discharged from hospital with excessive amounts of pain drugs. That finding led MHRA to encourage marketing authorization holders and local drug formularies to offer smaller packs “to give flexibility in prescribing in original packs, so that patients receive all product information, including warnings of dependence.”
MHRA report, More
Commission launches second call for EU reference laboratories for high-risk diagnostics
The European Commission has again asked member states to submit applications on behalf of potential EU reference laboratories (EURLs) for high-risk in vitro diagnostics (IVDs).
Officials put out a call for EURLs across eight categories of class D devices in 2022. The Commission later designated five EURLs covering four categories. For the other four categories, the Commission found there were “either no laboratories that satisfied the criteria or their combined capacity was insufficient to cover the expected volume of requests.”
Now, the Commission has begun a second call for two waves of applications. The first wave covers three of the categories that were left without a EURL after the first round of applications. Laboratories need to apply to their member state for those categories by around 15 April. The second wave covers all eight categories and has an indicative submission deadline for laboratories in January 2026.
Commission notice
Other News:
EFPIA has begun legal proceedings to challenge the extended producer responsibility obligations of the Urban Wastewater Treatment Directive. The trade group, which signaled its intent to take legal action early this month, wants clarity on how the decision to make two industries bear the cost of cleaning water aligns with the polluter-pays principle. Medicines for Europe supports the action. EFPIA notice
MedTech Europe has called for lawmakers to prioritize the structural reform of device and diagnostic regulations to make the EU more competitive. Open letter
In recent months, the Commission has collected and reviewed feedback on how to address supply chain vulnerabilities and reduce the European Union’s dependency on other countries. The goal is to bolster the supply of critical medicines and improve the availability of other drugs of common interest. With the consultation now closed, the Commission has published the Act.
The goals of the Act include using the aggregated demand of EU member states through collaborative procurement procedures. In a Q&A on the proposals, the Commission said the Act provides a framework for member states to request its “support in using different collaborative procurement tools for critical medicines and other medicines of common interest, under certain conditions.”
There are three options to carry out the work. The Commission can support cross-border procurement between member states, procure certain medicines for member states or voluntarily work with member states in joint procurement. Procurement “would always be voluntary and in respect of the principles of subsidiarity and proportionality,” the Commission said.
Pharma trade group EFPIA said it “welcomes the efforts to introduce criteria beyond price for the public procurement of critical medicines” but raised concerns with the inclusion of strengthened collaborative procurement options.
The options “may be appropriate under very specific circumstances where they accelerate patient access to critical medicines,” EFPIA said, but “a systematic application could create more harm than offering a more permanent solution to access related issues.” The trade group said clarity is needed to identify “circumstances where collaborative procurement options would improve access beyond existing national pricing and reimbursement pathways.”
EFPIA also commented on the Commission’s planned approach to the contingency stock requirements imposed by some EU countries. The Act warns national stockpiles “can have a serious negative impact on the internal market and other member states.” To avoid that outcome, the Commission said contingency stock obligations should consider the principles of proportionality, transparency and solidarity.
The Commission is preparing guidelines intended to stop the scope and timing of national stockpiling requirements from harming the internal market. EFPIA said “the Act needs to go further and provide an effective response to fragmented national contingency stock requirements that disrupt the functionality of the single market.”
Medicines for Europe, a trade group for off-patent drugmakers, also commented on contingency stocks. The organization wants legislators to support “more EU solidarity on strategic EU reserves and national stockpiling mandates to ensure that patient access to medicines takes precedence over hoarding in the event of a medicine shortage.” Medicines for Europe called the Act a “major milestone.”
Press release, Commission Q&A, EFPIA statement
EMA finalizes updated guidelines on clinical trials of depression, epileptic disorder drugs
The European Medicines Agency (EMA) has finalized guidelines on the clinical investigation of depression and epileptic disorder drugs.
EMA released draft versions of the documents for consultation in 2023. The agency has kept most of the draft wording of both guidelines while still making significant additions and deletions of text. Changes include the addition of new advice on clinical trials of psychedelics to treat depression, a topic that is completely absent from the guidance EMA published in 2013.
After the consultation, EMA added more advice on expectancy and unblinding in psychedelic trials. The final guidance says it is “particularly important to assess and report success of blinding with appropriate methods, predefined in the trial protocol.” EMA shared details on how to mitigate the potential for participants’ awareness of whether they received the study drug or placebo to influence their response.
“An effective strategy might involve systematically assessing participants' awareness of their treatment allocation to ensure the reliability of blinding,” EMA said. “Conducting trials with different designs, e.g. offering open label treatment after the double-blind placebo-controlled phase for those in the control group or including different doses (low, middle and high) without placebo could help addressing these challenges and provide complementary information to estimate the nocebo effect.”
Changes to the epilepsy guideline include the removal of a line about the need to justify “the underlying assumption that the seizure risk within a patient is constant over time” and the addition of text about alternative methods for assessing efficacy. The agency said sponsors could measure “seizure free days in patient diaries, particularly for those seizure types that do not occur frequently enough on prolonged EEG recordings, for patients who cannot fully cooperate with prolonged EEG monitoring.”
Depression guideline, Epilepsy guideline
MHRA removes indication from prolonged-release opioid label over safety concerns
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has removed postoperative pain from the approved indications of all prolonged-release opioids.
MHRA’s Commission on Human Medicines found using prolonged-release opioids to treat pain after an operation may raise the risk of breathing difficulties and persistent use or dependence on the drugs. The risks in postoperative patients outweigh the risks, MHRA concluded. That position led the agency to axe the indication from the licenses of modified-release morphine and oxycodone products.
Morphine and oxycodone were the only prolonged-release opioids previously recommended for acute postoperative pain relief. MHRA is adding warnings about the adverse events to the product information for all modified-release opioids.
The agency also noted that patients may be discharged from hospital with excessive amounts of pain drugs. That finding led MHRA to encourage marketing authorization holders and local drug formularies to offer smaller packs “to give flexibility in prescribing in original packs, so that patients receive all product information, including warnings of dependence.”
MHRA report, More
Commission launches second call for EU reference laboratories for high-risk diagnostics
The European Commission has again asked member states to submit applications on behalf of potential EU reference laboratories (EURLs) for high-risk in vitro diagnostics (IVDs).
Officials put out a call for EURLs across eight categories of class D devices in 2022. The Commission later designated five EURLs covering four categories. For the other four categories, the Commission found there were “either no laboratories that satisfied the criteria or their combined capacity was insufficient to cover the expected volume of requests.”
Now, the Commission has begun a second call for two waves of applications. The first wave covers three of the categories that were left without a EURL after the first round of applications. Laboratories need to apply to their member state for those categories by around 15 April. The second wave covers all eight categories and has an indicative submission deadline for laboratories in January 2026.
Commission notice
Other News:
EFPIA has begun legal proceedings to challenge the extended producer responsibility obligations of the Urban Wastewater Treatment Directive. The trade group, which signaled its intent to take legal action early this month, wants clarity on how the decision to make two industries bear the cost of cleaning water aligns with the polluter-pays principle. Medicines for Europe supports the action. EFPIA notice
MedTech Europe has called for lawmakers to prioritize the structural reform of device and diagnostic regulations to make the EU more competitive. Open letter
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