Medicines for Europe has called for policymakers to take “rapid” action to reform drug procurement and pricing models in light of inflation that is driving up the costs of producing off-patent therapeutics.
The trade group, which represents generic and biosimilar manufacturers in Europe, issued the request in response to the 10% inflation now faced by its members. Inflation affects raw materials, transport, fuel, energy and other components needed to manufacture medicines. While the cost of production is rising, Medicines for Europe said “rigid pricing policies” are preventing manufacturers from charging more and threatening the availability of off-patent drugs.
“The EU and member states must quickly implement policy measures that protect patient access to essential medicines, particularly during these challenging times,” Victor Lino Mendonça, chair of the generic market access committee at Medicines for Europe, said in a statement.
Mendonça and colleagues have identified two reforms to address the situation. First, the trade group wants officials to “reform medicines procurement and pricing models to include security of supply as a criteria.” Second, the body calls for Europe to “allow companies to adjust off-patent medicine prices to inflation.”
The trade group also wants officials to protect drugmakers in emergency plans for gas and oil supplies — the trade group has previously warned against subjecting the industry to energy rationing — and to encourage member states to tackle the impact of inflation with the local industry (RELATED: Euro Roundup, Regulatory Focus 28 July 2022).
Press Release
Team-NB adopts position paper on cybersecurity, use of off-label data for medical devices
The European Association for Medical devices of Notified Bodies (Team-NB) has adopted position papers on cybersecurity and data generated from off-label use.
In the cybersecurity document, the trade group discusses how a lack of experts combined with an “increased fragmentation within the European frameworks” are creating challenges for notified bodies. The position paper is intended to reflect the current state of the art and make cybersecurity conformity assessments as efficient as possible without compromising the quality.
Team-NB is recommending the adoption of standards such as IEC 81001-5-1:2021, an International Organization for Standardization document that it expects to be harmonized by the European Commission shortly. The trade group is advising manufacturers to adopt the standard as soon as is feasible.
The position paper also calls for the harmonization of the approach to security risk management, for example by using a systematic modeling technique, such as STRIDE, to ensure that all relevant threats are covered. “The readability for third parties when using a systematic risk approach can support efficient assessment by notified bodies,” according to the paper.
One day after publishing the cybersecurity document, Team-NB released a position paper on the off-label use of devices under the EU Medical Device Regulation (MDR). As the position paper explains, MDR only mentions off-label use in the context of a request for manufacturers to proactively identify via postmarketing activities whether their products are being used outside of the authorized indication.
After defining off-label use, the paper discusses the value of data generated when physicians use devices off-label and whether it can be used to expand the label. Team-NB states off-label data, while sometimes being sufficient to support label expansions, often can be too low quality to enable evidence-based conclusions. When companies identify off-label use, they should assess whether it addresses a genuine need and potentially collect high-quality data.
Position Paper, More
DKMA switches to quality review of documents template, ending use of special Danish version
The Danish Medicines Agency (DKMA) has changed its approach to the submission of summaries of product characteristics in connection to marketing authorizations. DKMA will now use the Danish version of the quality review of documents (QRD) template.
Until recently, DKMA required companies to use a special Danish template for the summaries of product characteristics for human, radioactive and veterinary medicines. That changed on 1 October. DKMA is removing the templates from its website.
“Going forward, the current Danish QRD template is to be used for submissions of translations for new marketing authorisations under the mutual recognition procedure or the decentralized procedure as well as for submissions of proposals for Danish summaries of product characteristics in the purely national procedure for applications for new marketing authorizations,” DKMA wrote.
The agency said the new requirements mean that the headings of the authorized summaries of product characteristics over time will be different from each other. The differences reflect the fact that the headings of the individually authorized Danish summaries of product characteristics will be changed in step with regulatory activities and updates to the QRD template.
DKMA Notice, More
MHRA receives funding to improve regulatory certainty for digital mental health tools
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has received funding to improve regulatory certainty and safety for digital mental health tools.
Wellcome has agreed to provide MHRA and the National Institute for Health and Care Excellence (NICE) with £1.8 million ($2.0 million) over the next three years. The money will enable a review of the medical device regulations to produce guidance to support digital mental health. The guidance will cover topics such as what qualifies as a medical device and assigning digital tools to risk classes.
Johan Ordish, head of software and AI at MHRA, explained the need for the guidance in a statement.
“There are a number of regulatory complexities in establishing when these products should be regulated and what evidence they must have to demonstrate safety and effectiveness. We need to make sure that we are able to answer these questions, to ensure that patients can be confident in the choices they make to support their mental health,” Ordish said.
MHRA plans to engage with people with lived experience of mental health conditions to inform how it will regulate the field. NICE’s involvement is intended to “simplify and streamline the process of getting wide-scale adoption of safe, clinical and cost-effective digital mental health products.”
Press Release
Other news:
In the UK, Sanofi is recalling a treatment for nausea and vertigo after finding the syrup contained a nitrosamine above the accepted limit. MHRA Notice
The trade group, which represents generic and biosimilar manufacturers in Europe, issued the request in response to the 10% inflation now faced by its members. Inflation affects raw materials, transport, fuel, energy and other components needed to manufacture medicines. While the cost of production is rising, Medicines for Europe said “rigid pricing policies” are preventing manufacturers from charging more and threatening the availability of off-patent drugs.
“The EU and member states must quickly implement policy measures that protect patient access to essential medicines, particularly during these challenging times,” Victor Lino Mendonça, chair of the generic market access committee at Medicines for Europe, said in a statement.
Mendonça and colleagues have identified two reforms to address the situation. First, the trade group wants officials to “reform medicines procurement and pricing models to include security of supply as a criteria.” Second, the body calls for Europe to “allow companies to adjust off-patent medicine prices to inflation.”
The trade group also wants officials to protect drugmakers in emergency plans for gas and oil supplies — the trade group has previously warned against subjecting the industry to energy rationing — and to encourage member states to tackle the impact of inflation with the local industry (RELATED: Euro Roundup, Regulatory Focus 28 July 2022).
Press Release
Team-NB adopts position paper on cybersecurity, use of off-label data for medical devices
The European Association for Medical devices of Notified Bodies (Team-NB) has adopted position papers on cybersecurity and data generated from off-label use.
In the cybersecurity document, the trade group discusses how a lack of experts combined with an “increased fragmentation within the European frameworks” are creating challenges for notified bodies. The position paper is intended to reflect the current state of the art and make cybersecurity conformity assessments as efficient as possible without compromising the quality.
Team-NB is recommending the adoption of standards such as IEC 81001-5-1:2021, an International Organization for Standardization document that it expects to be harmonized by the European Commission shortly. The trade group is advising manufacturers to adopt the standard as soon as is feasible.
The position paper also calls for the harmonization of the approach to security risk management, for example by using a systematic modeling technique, such as STRIDE, to ensure that all relevant threats are covered. “The readability for third parties when using a systematic risk approach can support efficient assessment by notified bodies,” according to the paper.
One day after publishing the cybersecurity document, Team-NB released a position paper on the off-label use of devices under the EU Medical Device Regulation (MDR). As the position paper explains, MDR only mentions off-label use in the context of a request for manufacturers to proactively identify via postmarketing activities whether their products are being used outside of the authorized indication.
After defining off-label use, the paper discusses the value of data generated when physicians use devices off-label and whether it can be used to expand the label. Team-NB states off-label data, while sometimes being sufficient to support label expansions, often can be too low quality to enable evidence-based conclusions. When companies identify off-label use, they should assess whether it addresses a genuine need and potentially collect high-quality data.
Position Paper, More
DKMA switches to quality review of documents template, ending use of special Danish version
The Danish Medicines Agency (DKMA) has changed its approach to the submission of summaries of product characteristics in connection to marketing authorizations. DKMA will now use the Danish version of the quality review of documents (QRD) template.
Until recently, DKMA required companies to use a special Danish template for the summaries of product characteristics for human, radioactive and veterinary medicines. That changed on 1 October. DKMA is removing the templates from its website.
“Going forward, the current Danish QRD template is to be used for submissions of translations for new marketing authorisations under the mutual recognition procedure or the decentralized procedure as well as for submissions of proposals for Danish summaries of product characteristics in the purely national procedure for applications for new marketing authorizations,” DKMA wrote.
The agency said the new requirements mean that the headings of the authorized summaries of product characteristics over time will be different from each other. The differences reflect the fact that the headings of the individually authorized Danish summaries of product characteristics will be changed in step with regulatory activities and updates to the QRD template.
DKMA Notice, More
MHRA receives funding to improve regulatory certainty for digital mental health tools
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has received funding to improve regulatory certainty and safety for digital mental health tools.
Wellcome has agreed to provide MHRA and the National Institute for Health and Care Excellence (NICE) with £1.8 million ($2.0 million) over the next three years. The money will enable a review of the medical device regulations to produce guidance to support digital mental health. The guidance will cover topics such as what qualifies as a medical device and assigning digital tools to risk classes.
Johan Ordish, head of software and AI at MHRA, explained the need for the guidance in a statement.
“There are a number of regulatory complexities in establishing when these products should be regulated and what evidence they must have to demonstrate safety and effectiveness. We need to make sure that we are able to answer these questions, to ensure that patients can be confident in the choices they make to support their mental health,” Ordish said.
MHRA plans to engage with people with lived experience of mental health conditions to inform how it will regulate the field. NICE’s involvement is intended to “simplify and streamline the process of getting wide-scale adoption of safe, clinical and cost-effective digital mental health products.”
Press Release
Other news:
In the UK, Sanofi is recalling a treatment for nausea and vertigo after finding the syrup contained a nitrosamine above the accepted limit. MHRA Notice
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