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A key health committee has called for the European Medicines Agency (EMA) to get a wider remit and an increased headcount to prevent shortages of essential medicines. The European Parliament committee made the request in a report that argues EMA should be made the regulatory authority in charge of preventing shortages.
In recent months, multiple Parliament committees have begun considering how to address the emerging problem of medicine shortages. As the group primarily responsible for the project, the Committee on the Environment, Public Health and Food Safety (ENVI) is central to the process.
ENVI set out what the project could mean for the regulation of medicines in the European Union in a report that passed by a vote of 79-1 this week. The report argues the European Commission and member states should designate EMA as the “regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff.”
The proposal is part of a broader push to better coordinate the response to drug shortages at an EU level. Other aspects of the plan for improved coordination include the creation of a “contingency reserve of medicines of strategic importance for health care” and the “introduction of centralized management to bring about greater transparency in the distribution chain.”
ENVI and the European Parliamentary Research Service published their first documents related to the drug shortage initiative as COVID-19 was spreading across the EU. The pandemic may have made it more likely that other EU groups will respond favorably to the called-for changes.
“Our dependence on third countries has been exposed by the current pandemic. It is necessary to relocate certain types of production, to harmonize legislation and to strengthen cooperation between member states in order to achieve greater solidarity and to regain our independence,” ENVI rapporteur Nathalie Colin-Oesterlé said in a statement.
ENVI expects the report to be on the agenda when Parliament meets in September. If ENVI gets its way, the report will inform the pharmaceutical strategy currently in development at the Commission.
Press Release, ENVI Opinion
EU Parliament clears regulatory barrier to COVID-19 vaccine development
The European Parliament has voted to temporarily exempt COVID-19 vaccines from regulations on genetically modified organisms (GMOs). EU politicians expect the action to avoid a significant delay to the availability of vaccines against the pandemic coronavirus.
By the EU’s own admission, achieving compliance with legislation on GMO clinical trials and getting the required consents “is complex and can take a significant amount of time.” The complexity scales in line with the size of the clinical trial, as sponsors need to submit multiple requests when running studies in multiple countries, each of which has a different process for seeking consent.
“It is therefore particularly difficult to conduct multi-center clinical trials with investigational medicinal products that contain or consist of GMOs involving several Member States,” the European Parliament wrote in legislation it adopted this week by 505 votes to 67, with 109 abstentions.
The legislation frees sponsors of COVID-19 vaccine clinical trials from the need to undergo a prior environmental risk assessment or secure the consent of member states. Instead, sponsors only need to “implement appropriate measures to minimize foreseeable negative environmental impacts.” Sponsors will retain that flexibility for as long as the World Health Organization declares COVID-19 to be a pandemic.
ENVI members supported the temporary lifting of the GMO requirements in a debate last week. The committee used the debate to stress that vaccine quality, safety and efficacy standards must be maintained.
Press Release, Adopted Text
UK review pushes for ‘substantial revision’ of MHRA to fix safety failings
An independent, government-commissioned review has called for the “substantial revision” of the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The authors of the review are pushing for change in light of perceived failures in MHRA’s approach to the reporting of adverse events, regulation of medical devices and engagement with the public.
The UK government ordered the independent review in response to criticism of how MHRA and the broader healthcare system responded to concerns patients raised about the safety of surgical mesh and other products. After reviewing MHRA’s role in the scandals, Baroness Cumberlege, who led the investigation, called for substantial changes to the agency.
“We are recommending that the regulator of medicines and medical devices, the MHRA, is overhauled. It needs to change and radically improve the way that concerns about medicines and devices are detected and acted upon. The regulation of devices in particular needs urgent change,” Cumberlege said at a press conference.
Cumberlege wants MHRA to approach medical devices more like it handles medicines. The review calls for MHRA to establish a premarket regulatory framework for medical devices that is clinically focused and “at least as stringent” as incoming EU rules.
The review also criticized MHRA’s handling of adverse events, stating the Yellow Card system the agency uses to collect adverse event reports “needs reform” to make it more user friendly and transparent. Cumberlege and her collaborators also identified a need for cultural changes, particularly regarding the way in which MHRA engages with patients.
Having spoken to MHRA, the authors of the review said the agency recognizes it needs to change. In a statement, MHRA said it takes the findings of the report “extremely seriously,” adding that it is “making changes without delay to ensure that we listen to patients.”
Some of the proposed changes will require new legislation. There appears to be an appetite in the UK Parliament for reform. Alex Norris, shadow public health minister in the opposition Labour Party, told Parliament he expected the review to have “profound implications” for MHRA. Having read the report, Norris said “and, boy, does it [have profound implications].”
Report, MHRA Response, Debate Transcript, More
EMA finalizes position on limiting nitrosamine impurities
EMA has finalized its opinion on limiting the presence of nitrosamine impurities in medicines. The Committee for Medicinal Products for Human Use (CHMP) explained what is expected of companies in a report featuring 11 recommendations.
As nitrosamine contamination concerns spread to more products, regulators around the world put in place new restrictions designed to prevent patients taking medicines that contain dangerous levels of the carcinogen. In the EU, that process has culminated in a CHMP report that tasks manufacturers with adapting their processes to prevent the formation of nitrosamines.
If a nitrosamine is detected despite the precautions, CHMP recommends manufacturers calculate a maximum level for the impurity using International Council for Harmonisation principles for “cohort of concern” substances considering a lifetime daily exposure.
EMA plans to provide updated instructions and timelines “soon.” The current policy applies until EMA publishes the new resources.
EMA Notice, CHMP Report, More
Other News:
The Dutch Medicines Evaluation Board (MEB) has defended the safety of paracetamol after a media report about contaminated products. MEB said levels of para-chloroaniline, a potential carcinogen, found in batches tested at the request of Dutch reporters were below the safety threshold. As such, MEB said it is safe to use paracetamol. MEB Notice
Finland has adopted amendments to its pharmaceutical legislation. The Finnish Medicines Agency (Fimea) said the changes are designed to ensure the availability of medicines. Fimea Notice
In recent months, multiple Parliament committees have begun considering how to address the emerging problem of medicine shortages. As the group primarily responsible for the project, the Committee on the Environment, Public Health and Food Safety (ENVI) is central to the process.
ENVI set out what the project could mean for the regulation of medicines in the European Union in a report that passed by a vote of 79-1 this week. The report argues the European Commission and member states should designate EMA as the “regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff.”
The proposal is part of a broader push to better coordinate the response to drug shortages at an EU level. Other aspects of the plan for improved coordination include the creation of a “contingency reserve of medicines of strategic importance for health care” and the “introduction of centralized management to bring about greater transparency in the distribution chain.”
ENVI and the European Parliamentary Research Service published their first documents related to the drug shortage initiative as COVID-19 was spreading across the EU. The pandemic may have made it more likely that other EU groups will respond favorably to the called-for changes.
“Our dependence on third countries has been exposed by the current pandemic. It is necessary to relocate certain types of production, to harmonize legislation and to strengthen cooperation between member states in order to achieve greater solidarity and to regain our independence,” ENVI rapporteur Nathalie Colin-Oesterlé said in a statement.
ENVI expects the report to be on the agenda when Parliament meets in September. If ENVI gets its way, the report will inform the pharmaceutical strategy currently in development at the Commission.
Press Release, ENVI Opinion
EU Parliament clears regulatory barrier to COVID-19 vaccine development
The European Parliament has voted to temporarily exempt COVID-19 vaccines from regulations on genetically modified organisms (GMOs). EU politicians expect the action to avoid a significant delay to the availability of vaccines against the pandemic coronavirus.
By the EU’s own admission, achieving compliance with legislation on GMO clinical trials and getting the required consents “is complex and can take a significant amount of time.” The complexity scales in line with the size of the clinical trial, as sponsors need to submit multiple requests when running studies in multiple countries, each of which has a different process for seeking consent.
“It is therefore particularly difficult to conduct multi-center clinical trials with investigational medicinal products that contain or consist of GMOs involving several Member States,” the European Parliament wrote in legislation it adopted this week by 505 votes to 67, with 109 abstentions.
The legislation frees sponsors of COVID-19 vaccine clinical trials from the need to undergo a prior environmental risk assessment or secure the consent of member states. Instead, sponsors only need to “implement appropriate measures to minimize foreseeable negative environmental impacts.” Sponsors will retain that flexibility for as long as the World Health Organization declares COVID-19 to be a pandemic.
ENVI members supported the temporary lifting of the GMO requirements in a debate last week. The committee used the debate to stress that vaccine quality, safety and efficacy standards must be maintained.
Press Release, Adopted Text
UK review pushes for ‘substantial revision’ of MHRA to fix safety failings
An independent, government-commissioned review has called for the “substantial revision” of the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The authors of the review are pushing for change in light of perceived failures in MHRA’s approach to the reporting of adverse events, regulation of medical devices and engagement with the public.
The UK government ordered the independent review in response to criticism of how MHRA and the broader healthcare system responded to concerns patients raised about the safety of surgical mesh and other products. After reviewing MHRA’s role in the scandals, Baroness Cumberlege, who led the investigation, called for substantial changes to the agency.
“We are recommending that the regulator of medicines and medical devices, the MHRA, is overhauled. It needs to change and radically improve the way that concerns about medicines and devices are detected and acted upon. The regulation of devices in particular needs urgent change,” Cumberlege said at a press conference.
Cumberlege wants MHRA to approach medical devices more like it handles medicines. The review calls for MHRA to establish a premarket regulatory framework for medical devices that is clinically focused and “at least as stringent” as incoming EU rules.
The review also criticized MHRA’s handling of adverse events, stating the Yellow Card system the agency uses to collect adverse event reports “needs reform” to make it more user friendly and transparent. Cumberlege and her collaborators also identified a need for cultural changes, particularly regarding the way in which MHRA engages with patients.
Having spoken to MHRA, the authors of the review said the agency recognizes it needs to change. In a statement, MHRA said it takes the findings of the report “extremely seriously,” adding that it is “making changes without delay to ensure that we listen to patients.”
Some of the proposed changes will require new legislation. There appears to be an appetite in the UK Parliament for reform. Alex Norris, shadow public health minister in the opposition Labour Party, told Parliament he expected the review to have “profound implications” for MHRA. Having read the report, Norris said “and, boy, does it [have profound implications].”
Report, MHRA Response, Debate Transcript, More
EMA finalizes position on limiting nitrosamine impurities
EMA has finalized its opinion on limiting the presence of nitrosamine impurities in medicines. The Committee for Medicinal Products for Human Use (CHMP) explained what is expected of companies in a report featuring 11 recommendations.
As nitrosamine contamination concerns spread to more products, regulators around the world put in place new restrictions designed to prevent patients taking medicines that contain dangerous levels of the carcinogen. In the EU, that process has culminated in a CHMP report that tasks manufacturers with adapting their processes to prevent the formation of nitrosamines.
If a nitrosamine is detected despite the precautions, CHMP recommends manufacturers calculate a maximum level for the impurity using International Council for Harmonisation principles for “cohort of concern” substances considering a lifetime daily exposure.
EMA plans to provide updated instructions and timelines “soon.” The current policy applies until EMA publishes the new resources.
EMA Notice, CHMP Report, More
Other News:
The Dutch Medicines Evaluation Board (MEB) has defended the safety of paracetamol after a media report about contaminated products. MEB said levels of para-chloroaniline, a potential carcinogen, found in batches tested at the request of Dutch reporters were below the safety threshold. As such, MEB said it is safe to use paracetamol. MEB Notice
Finland has adopted amendments to its pharmaceutical legislation. The Finnish Medicines Agency (Fimea) said the changes are designed to ensure the availability of medicines. Fimea Notice
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