While the systems and processes EU member states use to appraise medicines are one barrier to access, “more interrelated factors explain unavailability and delays” and need to be addressed, according to EFPIA.
“[The factors] range from a slow regulatory process, late initiation of market access applications, reimbursement delays due to inefficient processes and duplicative evidence requirements, and finally, a slow uptake of innovation due to local formulary decisions and endorsement by clinicians,” EFPIA wrote.
Echoing the European Health Coalition, which it is a member of, EFPIA proposed establishing a multi-stakeholder forum. The coalition wants members of the forum to “discuss all drivers and barriers to access innovation, including economic, budgetary, organizational and regulatory.”
As EFPIA sees it, the forum will facilitate an analysis of “the root causes of unequal patient access and supply of medicines.” EFPIA said the analysis will show “that an effective, targeted response to the access and availability challenges does not lie in a reduction of incentives for innovation or in wholesale changes to the pharmaceutical legislation but rather requires a structured and inclusive dialogue among all relevant stakeholders.”
By collaborating, EFPIA thinks EU stakeholders can create proposals that speed the regulatory process, increase transparency, align price with value, improve the efficiency and quality of value assessment, and ensure equity of access.
EFPIA also reiterated its opposition to the current joint HTA plan. The trade group praised aspects of the idea but said the European Parliament needs to raise the “ambition in the HTA regulation” and fight for clear simplification.
“If duplication and national gold plating of the centralized clinical assessment are not avoided, the Regulation risks imposing an additional layer of assessment on the 27 national processes in place,” EFPIA wrote.
EMA updates guide to individual case safety report implementation
The European Medicines Agency (EMA) has updated its individual case safety report (ICSR) implementation guide. EMA and the Heads of Medicines Agencies (HMA) prepared the guidance to help pharma companies and clinical trial sponsors prepare for changes to side effect reporting.
From 30 June 2022, users of the EudraVigilance adverse event system will report individual cases of suspected side effects using the ISO ICSR/ICH E2B(R3) format and associated standard terminology for pharmaceutical form and route of administration. Ahead of the ISO format becoming mandatory, EMA and HMA have deleted references to ICH E2B(R2) from the ICSR implementation guide and outlined the need to switch to the other format.
“ICSRs that are accepted in the previous ICH E2B(R2) ICSR format needs to be converted to the ISO ICSR format upon receipt in EudraVigilance. However, as part of this process, important information is often not available in dedicated data elements and may only be found in case narratives. This reduces data quality as well as search and data analysis capabilities,” the guidance states.
The removal of references to ICH E2B(R2) is one of several changes designed to ensure the industry has up-to-date information ahead of the switch to the ISO ICSR/ICH E2B(R3) format. EMA and HMA also used the update to offer guidance on the use of European Directorate for the Quality of Medicines (EDQM) terms for routes of administration and dosage forms.
A new section of the document explains that the EDQM terms comply with the ISO 11239 standard. The EDQM database of terms is updated as soon as new terms are available and the EudraVigilance system synchronizes the EDQM code lists every night. The updates have implications for users of EudraVigilance.
“Organizations should also aim to regularly update their systems with EDQM changes to ensure that they are able to process ICSRs downloaded from EudraVigilance correctly and to avoid rejections of submissions of ICSRs if terms are marked as non-current by EDQM,” the guidance states.
Implementation Guide, More
MHRA shares guidance on transparent face masks
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance for manufacturers of transparent face masks following the release of technical specifications for transparent face masks by the UK government.
Clear medical or surgical face masks intended to protect patients are Class I devices. As such, the products must meet the same design and safety requirements as other surgical face masks.
“Transparent masks may only state that they are Type IIR when they have met the requirements of the EN 14683:2019 standard in full. If only partial compliance is achieved then they must not be labelled or advertised as Type IIR,” MHRA wrote.
MHRA also advised manufacturers of transparent face masks to work toward the recent technical specifications from the UK government when bringing their products to market as medical devices.
Swissmedic outlines upcoming changes to pharmacovigilance reporting
The Swiss Agency for Therapeutic Products (Swissmedic) will begin accepting pharmacovigilance reports only in an electronic format starting 1 July, according to a notice from the agency.
Starting then, marketing authorization holders (MAHs) will need to send reports via a Gateway connection or the ElViS electronic vigilance system. MAHs need to register to access either option. The Gateway is reserved for companies that file more than 50 reports a year.
Swissmedic said the changes are a response to increased adverse event reports filed in recent years, particularly by the pharmaceutical industry. Mandating electronic submissions is part of an effort to “ensure that reports are processed promptly, and possible risks are identified swiftly.”
AIFA warns of rising counterfeit medicine trade in Italy
The Italian Medicines Agency (AIFA) has warned about an increase in reports of trade in counterfeit medicines.
AIFA highlighted cases including the falsification of the erectile disfunction drug Cialis (tadalafil, Eli Lilly) in an online advertisement. AIFA also described its work with eBay to remove offers related to falsified versions of an anti-cellulite cream from its platform.
The regulator asks consumers who see suspected trade in counterfeit medicines to contact the agency and a health-focused law enforcement unit. AIFA said vigilance is particularly important now considering reports of the illegal sale of COVID-19 vaccines outside of the EU.
AIFA Notice (Italian)
The Dutch Medicines Evaluation Board (MEB) has entered a collaboration with a trade group that represents drugstores in the Netherlands to ensure the availability and proper use of over-the-counter medicines. The agreement builds on an existing relationship. MEB Notice (Dutch)
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