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Posted 24 February 2022 | By Nick Paul Taylor 

Euro Roundup: EFPIA pushes back against price transparency in EU cancer strategy

3041 A proposal to publish the net prices of cancer drugs in different EU countries will remove “the flexibility for companies to adapt the price of a medicine to a Member State’s economic and healthcare settings,” according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).
 
As part of a wide-reaching text on equal access to cancer treatments, the European Parliament has called for “more transparency throughout the pharmaceutical system, especially regarding pricing components, reimbursement criteria and the actual (net) prices of medicines in different Member States to ensure fairer prices and bring public accountability to the pharmaceutical sector.”
 
“We are concerned that some positions within the report will have a negative impact on our ability to deliver new treatments and the ability to adapt the price of new oncology treatments in different countries, based on their economic conditions and other value-based considerations,” EFPIA wrote.
 
Chief among their concerns is a proposal to publish net prices. EFPIA prioritized retaining the flexibility to charge different prices in different countries last week, when it set out a vision for “Equity-Based Tiered Pricing” that would link the price of innovative medicines to the ability of each country to pay.
 
EFPIA also diverges from the Parliament on the publication and use of information about the cost of drug development. Parliament is encouraging Member States to ask, “pharmaceutical companies to provide information on research and development costs, including the financing from public resources, prior to market authorization, as well as on the tax benefits and subsidies they have received.” The Parliament is also calling for the European Medicines Agency to step up its transparency compliance audits.
 
EFPIA noted that it is open to discussing “how industry could make the information it already shares more consistent and useful,” before going on to make the case against more radical changes. The trade group said, “estimates of R&D expenditure are not helpful for determining the appropriate pricing of medicines,” using mRNA as an example to argue “that It is simply not feasible to attribute decades of science in a particular avenue of science to one particular therapy.”
 
 
EFPIA Notice, EU Text, Press Release
 
 
EDQM makes remote inspections an ‘integral part’ of API supervision program
 
The European Directorate for the Quality of Medicines (EDQM) has found Real-Time Remote Inspections (RTEMIS) are ready to become an “integral part” of its system for overseeing manufacturers of active substances.
 
EDQM began piloting RTEMIS in November 2020 in response to the pandemic. With restrictions on travel and face-to-face interactions interrupting its inspection program, EDQM created RTEMIS to enable it to evaluate a company’s compliance with good manufacturing practices (GMPs) over a live video feed.
 
“After evaluating the results and achievements obtained during the pilot phase of the remote inspection project, the EDQM has concluded that the RTEMIS approach is suitable to become an integral part of its system for the supervision of manufacturers of active substances. It will therefore complement existing tools, such as on-site inspections and documentation-based GMP assessment,” EDQM wrote.
 
Starting this year, companies that apply for certificates of suitability to the monographs of the European Pharmacopoeia may be notified for RTEMIS. Notifications will be based on the company’s commitment of willingness to be inspected and will be subject to fees, EDQM said. As such, companies are expected to ensure they have appropriate IT infrastructure and hardware for the inspection.
 
EDQM Notice
 
Commission posts final guideline on GMP import rules, starting 6-month countdown
 
The European Commission has published final guidelines in the importation of medicinal products. In Annex 21 of the Eudralex volume on GMPs, the Commission describes the pharmaceutical quality system (QMS) and documentation that are needed to import products into the European Union.
 
Most of the guideline is unchanged from the draft the Commission released for consultation in 2020. The text still describes the principles of importation, covering topics such as GMP compliance and the role of the Qualified Person (QP), before going into details about QMS, premises and equipment, operations, documentation and handling complaints.
 
Some details have changed, though. The scope of the guideline now explicitly covers investigational medicinal products, as well as human and veterinary medicines, and the principles clarify that fiscal transactions, in which a product changes ownership but stays in the EU, are excluded. The Commission has also added “packing list” to the shipping details that should be available to inspect at the QP site.
 
The annex is set to come into operation on 21 August.
 
Annex 21
 
Finland seeks feedback on draft investigational drug GMPs
 
The Finnish Medicines Agency (Fimea) is seeking feedback on draft regulations covering the production of investigational medicinal products.
 
When brought into effect, the regulation will repeal existing Fimea rules on GMPs and clinical trials. The regulation refers to the EU texts that apply to the production of medicinal products and sets out the use of risk assessments to determine the approach to excipients.
 
Other sections of the text cover topics including the acceptable languages for the labels of investigational products, the rules on the production of medicines by hospital pharmacies and definitions of key terms.
 
Fimea is accepting feedback until 31 March.
 
Fimea Notice (Finnish)
 
Netherlands implements parallel approval, reimbursement assessments
 
The Dutch Medicines Evaluation Board (MEB) is making parallel assessment of applications for approval and reimbursement its standard approach this month. MEB made the change after completing a pilot of the model that began in 2019.
 
Working with the country’s National Health Care Institute (Zorginstituut), MEB expects parallel assessments to result in reimbursement decisions being reached three months earlier. The time saving could cut the lag between a medicine being approved for use and gaining the reimbursement that is important to patient access.
 
MEB first saw the benefits of the parallel approach during the assessment of Novo Nordisk’s Rybelsus. Zorginstituut sent reimbursement advice for Rybelsus to the government days after the drug won approval in Europe, resulting in the drug being reimbursed two months later.
 
MEB Notice (Dutch)
 
Other news:
 
The French National Agency for Medicines and Health Products Safety (ANSM) is working on specifications for cannabis-based medicines produced for use in France, setting up a temporary scientific committee that met for the first time late last week. The initiative follows the start of a medicinal cannabis pilot in France and the passing of a decree. ANSM Notice (French)

 

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