The Swiss Agency for Therapeutic Products (Swissmedic) has detailed its response to the European Union solution for a problem that could disrupt the supply of medical devices in the region.
Last year, the EU Medical Device Coordination Group published a paper, MDCG 2022-18, describing the powers that authorities have to allow the continued sale of products that lack certification. The powers apply if a company’s certificate under the old directive expires before it has completed the conformity assessment process under the Medical Device Regulation.
Competent authorities can issue a written communication telling the manufacturer to bring the device into compliance within the defined period. At that point, the manufacturer can place the device on the EU market. Switzerland, which is outside the EU, will also accept the written communications.
“In order to avoid disruption of supply with medical devices, the written communications issued by EU/EEA competent authorities are generally accepted in Switzerland as evidence that an evaluation according to has been conducted and that a period to re-establish conformity has been granted. A notification of Swissmedic or a duplication of this evaluation by Swissmedic is not necessary,” the agency wrote.
The rest of the Swissmedic response covers how market surveillance applies to devices covered by written confirmations and the issuing of free sales certificates, plus answers to frequently asked questions.
Swissmedic Notice
MDCG publishes guidance on notified body listings of standard fees for MDR and IVDR services
MDCG has published guidance on how notified bodies can comply with the requirement to make their rates for medtech regulatory services public.
Under the Medical Device Regulation and In Vitro Diagnostic Regulation, notified bodies must “establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available.” Neither regulation explains what that means in practice.
MDCG, building on its earlier definition of “publicly available,” has clarified what is expected of notified bodies in new guidance. The guidance features a template list of fees that should be accessible on the websites of notified bodies without a user needing to register. MDCG expects notified bodies to list fees in their local currency.
MDCG Guidance
AbbVie and Lilly leave UK voluntary pricing scheme amid claims costs are ‘spiraling out of control’
AbbVie and Eli Lilly have left the United Kingdom’s Voluntary Scheme for Branded Medicines Pricing and Access (VPAS). The scheme caps the growth of branded drug sales to control healthcare spending but, in the view of the two companies, is harming innovation and hurting their ability to operate sustainability in the UK.
VPAS is a non-contractual voluntary agreement between the Department of Health and Social Care and the Association of the British Pharmaceutical Industry (ABPI). The scheme, which has existed in some form for decades, caps annual branded medicine spending growth by the UK National Health Service (NHS) at 2%. Companies covered by the scheme return any overspend for reinvestment in the NHS. In 2021 and 2022, the industry repaid £600 million ($743 million) and £1.8 billion, respectively.
Branded manufacturers are expected to repay almost £3.3 billion — 26.5% of sales — this year. ABPI attributed the jump to increased health needs in the UK, partly because of the backlog that built up in the COVID-19 crisis, and other factors that have caused reality to diverge from pre-pandemic projections. The situation has persuaded Lilly to leave the voluntary scheme.
“The current scheme has harmed innovation, with costs spiraling out of control, and the UK falling behind other major countries to be left as a global outlier. We simply cannot stay signed up to a scheme which has such a punishing impact on innovation,” Laura Steele, Lilly’s president and general manager for Northern Europe, said.
Todd Manning, the UK general manager at AbbVie, said the 26.5% clawback rate is “not seen in any comparable country” and has “a demonstrable impact on [the company’s] ability to operate sustainably in the UK.”
Leaving VPAS will bring AbbVie and Lilly under the alternative Statutory Scheme for Branded Medicines, a program that the government enacts through law rather than through negotiation with the industry. The 2023 Statutory Scheme payment rate is 24.4%, However, in November the UK government said that figure “is considered” to be too low and as such was not expected to meet its objectives for the scheme in “light of higher-than-forecast growth in sales of branded medicines in 2022.”
The government outlined plans to review the statutory policy in response to negotiations about a new voluntary scheme. VPAS took effect at the start of 2019 and runs for five years. As such, the government expects a new agreement to be in place for the start of next year. The departure of AbbVie and Lilly from VPAS ratchets up the pressure on the government as ABPI seeks early talks about “a completely new future settlement.” The industry plans to publish proposals in the coming months.
“We have already seen the UK lose almost half of its global share of R&D over the last decade. For this trend to be reversed, we must develop a more internationally competitive scheme with the government that can genuinely support the life sciences vision,” Richard Torbett, chief executive at ABPI, said.
Press Release
EMA clarifies timelines for reporting adverse events discovered in hard copy local journals
The European Medicines Agency (EMA) has provided new advice for marketing authorization holders (MAHs) that learn about adverse events linked to their products through medical literature reports in “physical/hard copy local journals.”
In an update to its pharmacovigilance advice, EMA answers a new question: What is the day zero for individual case safety reports (ICSRs) described in physical/hard copy local journals? MAHs are expected to monitor scientific and medical publications in local journals in markets where their medicinal products have a marketing authorisation. Day zero refers to when the clock starts on reporting an ICSR.
When an adverse event is reported in physical media, there could be a lag between the publication of the paper and the MAH finding out about the safety issue. EMA has clarified that the clock starts on the day the MAH receives the journal.
“Day zero is the date when the minimum information for an ICSR to be valid is available. Organizations should take appropriate measures to obtain articles promptly in order to confirm the validity of a case,” the agency wrote.
EMA Update
EMA refines JAK inhibitor recommendations, discusses fatal liver failure linked to gene therapy
EMA’s Pharmacovigilance Risk Assessment Committee has refined its recommendation on the dosing of JAK inhibitors and shared details of a letter to healthcare professionals about Novartis’ Zolgensma.
Having previously recommended restrictions on the use of JAK inhibitors, the committee has now said the lower dose of Eli Lilly’s Olumiant should be used in patients at higher risk of blood clots, cardiovascular conditions and cancer. The recommendation is in line with EMA’s position on other JAK inhibitors.
The committee also discussed sending a direct healthcare professional communication to disclose fatal cases of acute liver failure in recipients of the gene therapy Zolgensma.
EMA Notice
Last year, the EU Medical Device Coordination Group published a paper, MDCG 2022-18, describing the powers that authorities have to allow the continued sale of products that lack certification. The powers apply if a company’s certificate under the old directive expires before it has completed the conformity assessment process under the Medical Device Regulation.
Competent authorities can issue a written communication telling the manufacturer to bring the device into compliance within the defined period. At that point, the manufacturer can place the device on the EU market. Switzerland, which is outside the EU, will also accept the written communications.
“In order to avoid disruption of supply with medical devices, the written communications issued by EU/EEA competent authorities are generally accepted in Switzerland as evidence that an evaluation according to has been conducted and that a period to re-establish conformity has been granted. A notification of Swissmedic or a duplication of this evaluation by Swissmedic is not necessary,” the agency wrote.
The rest of the Swissmedic response covers how market surveillance applies to devices covered by written confirmations and the issuing of free sales certificates, plus answers to frequently asked questions.
Swissmedic Notice
MDCG publishes guidance on notified body listings of standard fees for MDR and IVDR services
MDCG has published guidance on how notified bodies can comply with the requirement to make their rates for medtech regulatory services public.
Under the Medical Device Regulation and In Vitro Diagnostic Regulation, notified bodies must “establish lists of their standard fees for the conformity assessment activities that they carry out and shall make those lists publicly available.” Neither regulation explains what that means in practice.
MDCG, building on its earlier definition of “publicly available,” has clarified what is expected of notified bodies in new guidance. The guidance features a template list of fees that should be accessible on the websites of notified bodies without a user needing to register. MDCG expects notified bodies to list fees in their local currency.
MDCG Guidance
AbbVie and Lilly leave UK voluntary pricing scheme amid claims costs are ‘spiraling out of control’
AbbVie and Eli Lilly have left the United Kingdom’s Voluntary Scheme for Branded Medicines Pricing and Access (VPAS). The scheme caps the growth of branded drug sales to control healthcare spending but, in the view of the two companies, is harming innovation and hurting their ability to operate sustainability in the UK.
VPAS is a non-contractual voluntary agreement between the Department of Health and Social Care and the Association of the British Pharmaceutical Industry (ABPI). The scheme, which has existed in some form for decades, caps annual branded medicine spending growth by the UK National Health Service (NHS) at 2%. Companies covered by the scheme return any overspend for reinvestment in the NHS. In 2021 and 2022, the industry repaid £600 million ($743 million) and £1.8 billion, respectively.
Branded manufacturers are expected to repay almost £3.3 billion — 26.5% of sales — this year. ABPI attributed the jump to increased health needs in the UK, partly because of the backlog that built up in the COVID-19 crisis, and other factors that have caused reality to diverge from pre-pandemic projections. The situation has persuaded Lilly to leave the voluntary scheme.
“The current scheme has harmed innovation, with costs spiraling out of control, and the UK falling behind other major countries to be left as a global outlier. We simply cannot stay signed up to a scheme which has such a punishing impact on innovation,” Laura Steele, Lilly’s president and general manager for Northern Europe, said.
Todd Manning, the UK general manager at AbbVie, said the 26.5% clawback rate is “not seen in any comparable country” and has “a demonstrable impact on [the company’s] ability to operate sustainably in the UK.”
Leaving VPAS will bring AbbVie and Lilly under the alternative Statutory Scheme for Branded Medicines, a program that the government enacts through law rather than through negotiation with the industry. The 2023 Statutory Scheme payment rate is 24.4%, However, in November the UK government said that figure “is considered” to be too low and as such was not expected to meet its objectives for the scheme in “light of higher-than-forecast growth in sales of branded medicines in 2022.”
The government outlined plans to review the statutory policy in response to negotiations about a new voluntary scheme. VPAS took effect at the start of 2019 and runs for five years. As such, the government expects a new agreement to be in place for the start of next year. The departure of AbbVie and Lilly from VPAS ratchets up the pressure on the government as ABPI seeks early talks about “a completely new future settlement.” The industry plans to publish proposals in the coming months.
“We have already seen the UK lose almost half of its global share of R&D over the last decade. For this trend to be reversed, we must develop a more internationally competitive scheme with the government that can genuinely support the life sciences vision,” Richard Torbett, chief executive at ABPI, said.
Press Release
EMA clarifies timelines for reporting adverse events discovered in hard copy local journals
The European Medicines Agency (EMA) has provided new advice for marketing authorization holders (MAHs) that learn about adverse events linked to their products through medical literature reports in “physical/hard copy local journals.”
In an update to its pharmacovigilance advice, EMA answers a new question: What is the day zero for individual case safety reports (ICSRs) described in physical/hard copy local journals? MAHs are expected to monitor scientific and medical publications in local journals in markets where their medicinal products have a marketing authorisation. Day zero refers to when the clock starts on reporting an ICSR.
When an adverse event is reported in physical media, there could be a lag between the publication of the paper and the MAH finding out about the safety issue. EMA has clarified that the clock starts on the day the MAH receives the journal.
“Day zero is the date when the minimum information for an ICSR to be valid is available. Organizations should take appropriate measures to obtain articles promptly in order to confirm the validity of a case,” the agency wrote.
EMA Update
EMA refines JAK inhibitor recommendations, discusses fatal liver failure linked to gene therapy
EMA’s Pharmacovigilance Risk Assessment Committee has refined its recommendation on the dosing of JAK inhibitors and shared details of a letter to healthcare professionals about Novartis’ Zolgensma.
Having previously recommended restrictions on the use of JAK inhibitors, the committee has now said the lower dose of Eli Lilly’s Olumiant should be used in patients at higher risk of blood clots, cardiovascular conditions and cancer. The recommendation is in line with EMA’s position on other JAK inhibitors.
The committee also discussed sending a direct healthcare professional communication to disclose fatal cases of acute liver failure in recipients of the gene therapy Zolgensma.
EMA Notice
