Euro Roundup: EU alliance recommends harmonized stockpiling requirements to prevent drug shortages
Roundups | 06 March 2025 |
The Critical Medicines Alliance has put the creation of a “harmonized and balanced framework of stockpiling requirements” at the center of its recommendations for how to prevent drug shortages in the European Union.
Representatives of EU countries, key industries and other groups came together to form the Alliance and create recommendations. The European Commission published the resulting report. While the report does not necessarily reflect the official opinion of the Commission, it provides recommendations for the EU body, European countries and the Alliance’s stakeholders to consider and implement.
The report notes manufacturers now need to maintain contingency stocks of drugs in some countries. However, the national initiatives hinder “equitable distribution of essential medicinal products according to patient needs,” the Alliance said. Those concerns informed a call for a harmonized model.
“A clear framework covering both national and EU contingency stocks is needed to mitigate the potential negative consequences of current national contingency stocks,” the Alliance said. “It is also important to facilitate the reallocation of stocked medicinal products to Member States in case of shortage, ensuring that solidarity mechanisms are effective, and Member States have mechanisms that allow them to share the stock in time of need.”
The Alliance made specific recommendations such as the use of manufacturing and storage data to inform contingency stock obligations, the creation of stock management strategies to prevent waste and the transparent sharing of stock requirements.
EFPIA, a pharma trade group that said it is “actively engaged in the Alliance,” said the report aligns with its recommendations for a Critical Medicines Act. Yet, the trade group also raised concerns about the implementation of the Alliance’s recommendations. Some of the concerns relate to contingency stocks.
“If required, contingency stocks should be managed at the EU level to prevent duplication and inefficiencies,” EFPIA said. “The European Medicines Verification System already provides substantial data on supply and demand, making additional IT systems or data collection requirements unnecessary and duplicative.”
The trade group pushed back on the idea that products manufactured outside the EU are necessarily more vulnerable to supply disruption than drugs made in the region. EFPIA wants officials to factor trade agreements, geographical proximity, country stability indicators and other factors into assessments of supply risks. The trade group also said systematic joint procurement would harm supply sustainability.
Per the report, the next step could be the creation of a list of Critical Vulnerable Medicines based on assessments of structural supply vulnerabilities. The Alliance called for the creation of a preliminary draft list by mid-2025. EFPIA said that timeline is “too short,” quoting a technical report that outlined worries about the time and effort required to submit the required information to support its case.
Press Release, EFPIA Statement
MedTech Europe voices concerns with MDCG notified body text, calls for urgent action
MedTech Europe has joined with other industry groups to raise concerns about the Medical Device Coordination Group’s (MDCG) recently updated notified body requirements.
MDCG updated the document last month to change answers to existing questions and address a new query about the use of existing evidence to avoid the unnecessary duplication of work. However, several trade groups are concerned about the lack of new options for manufacturers to discuss clinical strategies with notified bodies before filing their submissions.
“The current situation represents significant costs with a potential impact on EU investment decisions, resources deployment for both manufacturers and notified bodies, but most importantly a delay in product availability for the patient e.g. a delay of up to 2-3 years for new products and potential patient ethical considerations,” the trade groups said.
In response, MedTech Europe and its co-signatories want the EU to publish an implementing act to clarify that it is possible to discuss clinical strategies with notified bodies before pre-submission. Such talks should only take place if there is a real need identified by the manufacturer, the trade groups said, to ensure the efficient use of notified body resources.
The goal is to facilitate alignment on expectations between manufacturers and notified bodies and make the conformity process more predictable. MedTech Europe found notified bodies had significantly challenged the clinical or performance evaluation for at least one application from half of the medical device companies it surveyed last year.
Press Release
Commission answers questions on European Health Data Space as start date approaches
The European Commission has published a frequently asked questions document about the European Health Data Space (EHDS).
The Commission released the FAQ in conjunction with the publication of the EHDS in the Official Journal of the EU. EHDS will enter into force on 26 March but, as the FAQ explains, the requirements will start to apply in a phased manner. Health data holders will need to submit descriptions of the data they hold to a health data access body by 26 March 2029 or 2031, depending on the type of data.
The FAQ defines “data holder” to help organizations understand if the requirements apply to them. A table clarifies what data is in and out of the scope of EHDS. Data from completed clinical trials are in scope but data from ongoing studies are out of scope. Similarly, data from implanted medical devices are in scope when held by the manufacturer but out of scope when only stored locally on the device.
Industry groups, which have raised concerns about EHDS throughout the legislative process, are still trying to shape the implementation of the regulation. EFPIA, MedTech Europe and 37 other groups published a call for effective stakeholder engagement and capacity building during implementation. The groups shared advice on a planned stakeholder forum and the need to provide funding for EHDS training.
Commission FAQ, Press Release
EMA seeks feedback on draft guideline for acute respiratory distress syndrome trials
The European Medicines Agency (EMA) is holding a consultation into the clinical investigation of acute respiratory distress syndrome (ARDS) treatments.
EMA published guidance on ARDS, a critical condition characterized by a sudden, severe impairment of lung function, in 2006. Since then, other groups have updated the ARDS diagnosis criteria and COVID-19 has increased the focus on the lung condition. The draft guideline addresses those developments.
There is a medical need to develop ARDS treatments that work regardless of the cause of the condition, the draft states. Developers of treatments that could support pandemic preparedness should talk to the Emergency Task Force, EMA said. The draft notes the potential for competition for trial participants during pandemics and recommends coordination within study networks and registries.
Draft Guideline
Other News:
EMA has finalized an addendum to its vaccine development guideline to address clinical trials in immunocompromised individuals. The text features advice on the design of safety and immunogenicity studies in immunocompromised people. EMA Addendum
EFPIA has said it intends to challenge recent EU urban wastewater treatment rules after warning that the rules had a disproportionate effect on the pharmaceutical and cosmetics industries in the EU General Court. The lobby group said the decision to focus the financial responsibility for the rules on the two sectors is unfair. EFPIA statement
MedTech Europe said the European Data Protection Board has adopted an overly strict interpretation of pseudonymized data as personal data. The trade group cited legal rulings to question assumptions about when pseudonymized data is classified as personal data. Consultation Feedback
EFPIA is planning to challenge the Urban Wastewater Treatment Directive before the EU General Court. The trade group will use the challenge to see clarity on why pharma is one of two industries that will bear the costs of pollution. EFPIA Notice
Representatives of EU countries, key industries and other groups came together to form the Alliance and create recommendations. The European Commission published the resulting report. While the report does not necessarily reflect the official opinion of the Commission, it provides recommendations for the EU body, European countries and the Alliance’s stakeholders to consider and implement.
The report notes manufacturers now need to maintain contingency stocks of drugs in some countries. However, the national initiatives hinder “equitable distribution of essential medicinal products according to patient needs,” the Alliance said. Those concerns informed a call for a harmonized model.
“A clear framework covering both national and EU contingency stocks is needed to mitigate the potential negative consequences of current national contingency stocks,” the Alliance said. “It is also important to facilitate the reallocation of stocked medicinal products to Member States in case of shortage, ensuring that solidarity mechanisms are effective, and Member States have mechanisms that allow them to share the stock in time of need.”
The Alliance made specific recommendations such as the use of manufacturing and storage data to inform contingency stock obligations, the creation of stock management strategies to prevent waste and the transparent sharing of stock requirements.
EFPIA, a pharma trade group that said it is “actively engaged in the Alliance,” said the report aligns with its recommendations for a Critical Medicines Act. Yet, the trade group also raised concerns about the implementation of the Alliance’s recommendations. Some of the concerns relate to contingency stocks.
“If required, contingency stocks should be managed at the EU level to prevent duplication and inefficiencies,” EFPIA said. “The European Medicines Verification System already provides substantial data on supply and demand, making additional IT systems or data collection requirements unnecessary and duplicative.”
The trade group pushed back on the idea that products manufactured outside the EU are necessarily more vulnerable to supply disruption than drugs made in the region. EFPIA wants officials to factor trade agreements, geographical proximity, country stability indicators and other factors into assessments of supply risks. The trade group also said systematic joint procurement would harm supply sustainability.
Per the report, the next step could be the creation of a list of Critical Vulnerable Medicines based on assessments of structural supply vulnerabilities. The Alliance called for the creation of a preliminary draft list by mid-2025. EFPIA said that timeline is “too short,” quoting a technical report that outlined worries about the time and effort required to submit the required information to support its case.
Press Release, EFPIA Statement
MedTech Europe voices concerns with MDCG notified body text, calls for urgent action
MedTech Europe has joined with other industry groups to raise concerns about the Medical Device Coordination Group’s (MDCG) recently updated notified body requirements.
MDCG updated the document last month to change answers to existing questions and address a new query about the use of existing evidence to avoid the unnecessary duplication of work. However, several trade groups are concerned about the lack of new options for manufacturers to discuss clinical strategies with notified bodies before filing their submissions.
“The current situation represents significant costs with a potential impact on EU investment decisions, resources deployment for both manufacturers and notified bodies, but most importantly a delay in product availability for the patient e.g. a delay of up to 2-3 years for new products and potential patient ethical considerations,” the trade groups said.
In response, MedTech Europe and its co-signatories want the EU to publish an implementing act to clarify that it is possible to discuss clinical strategies with notified bodies before pre-submission. Such talks should only take place if there is a real need identified by the manufacturer, the trade groups said, to ensure the efficient use of notified body resources.
The goal is to facilitate alignment on expectations between manufacturers and notified bodies and make the conformity process more predictable. MedTech Europe found notified bodies had significantly challenged the clinical or performance evaluation for at least one application from half of the medical device companies it surveyed last year.
Press Release
Commission answers questions on European Health Data Space as start date approaches
The European Commission has published a frequently asked questions document about the European Health Data Space (EHDS).
The Commission released the FAQ in conjunction with the publication of the EHDS in the Official Journal of the EU. EHDS will enter into force on 26 March but, as the FAQ explains, the requirements will start to apply in a phased manner. Health data holders will need to submit descriptions of the data they hold to a health data access body by 26 March 2029 or 2031, depending on the type of data.
The FAQ defines “data holder” to help organizations understand if the requirements apply to them. A table clarifies what data is in and out of the scope of EHDS. Data from completed clinical trials are in scope but data from ongoing studies are out of scope. Similarly, data from implanted medical devices are in scope when held by the manufacturer but out of scope when only stored locally on the device.
Industry groups, which have raised concerns about EHDS throughout the legislative process, are still trying to shape the implementation of the regulation. EFPIA, MedTech Europe and 37 other groups published a call for effective stakeholder engagement and capacity building during implementation. The groups shared advice on a planned stakeholder forum and the need to provide funding for EHDS training.
Commission FAQ, Press Release
EMA seeks feedback on draft guideline for acute respiratory distress syndrome trials
The European Medicines Agency (EMA) is holding a consultation into the clinical investigation of acute respiratory distress syndrome (ARDS) treatments.
EMA published guidance on ARDS, a critical condition characterized by a sudden, severe impairment of lung function, in 2006. Since then, other groups have updated the ARDS diagnosis criteria and COVID-19 has increased the focus on the lung condition. The draft guideline addresses those developments.
There is a medical need to develop ARDS treatments that work regardless of the cause of the condition, the draft states. Developers of treatments that could support pandemic preparedness should talk to the Emergency Task Force, EMA said. The draft notes the potential for competition for trial participants during pandemics and recommends coordination within study networks and registries.
Draft Guideline
Other News:
EMA has finalized an addendum to its vaccine development guideline to address clinical trials in immunocompromised individuals. The text features advice on the design of safety and immunogenicity studies in immunocompromised people. EMA Addendum
EFPIA has said it intends to challenge recent EU urban wastewater treatment rules after warning that the rules had a disproportionate effect on the pharmaceutical and cosmetics industries in the EU General Court. The lobby group said the decision to focus the financial responsibility for the rules on the two sectors is unfair. EFPIA statement
MedTech Europe said the European Data Protection Board has adopted an overly strict interpretation of pseudonymized data as personal data. The trade group cited legal rulings to question assumptions about when pseudonymized data is classified as personal data. Consultation Feedback
EFPIA is planning to challenge the Urban Wastewater Treatment Directive before the EU General Court. The trade group will use the challenge to see clarity on why pharma is one of two industries that will bear the costs of pollution. EFPIA Notice
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