Euro Roundup: EFPIA calls for EU to drive reform of WTO, shares feedback on emergency authority

News date: 18 November 2021Source: https://www.raps.org/news-and-articles/news-articles/2021/11/euro-roundup-efpia-calls-for-eu-to-drive-reform-of

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called on the European Union to take the lead on the reform of the World Trade Organization (WTO). The pharma trade group sees the 12th ministerial WTO conference as a chance to reform the international trading system and boost the world’s ability to respond to health crises.
 
As EFPIA sees it, trade played a key role in the response to COVID-19 and the development of the vaccines that changed the course of the pandemic was enabled by rules on intellectual property (IP). The trade group now wants WTO to strengthen the system, for example by adopting the Trade and Health Initiative that is designed to improve the resilience of the supply chain in crisis situations.
 
EFPIA published the statement alongside a report on the impact of IP provisions in EU free trade agreements. The report analyzes the question of whether longer periods of IP protection increase drug costs, concluding that, while the measures could theoretically add to spending, in practice the pharmaceutical share of healthcare costs stays flat or falls and the prices of medicines rise slower than inflation. 
 
Days later, EFPIA and Vaccines Europe touched on some of the same topics in a response to the European Commission’s plans to establish the Health Emergency preparedness and Response Authority (HERA). The trade groups voiced support for HERA’s end-to-end approach while seeking to limit when it intervenes on IP.
 
“A strong IP incentive system supports rapid and robust response to a health crisis. Voluntary licensing measures should therefore always be preferred over other measures. However, should the contractor fail to take reasonable steps to commercialize a particular medical countermeasure, HERA should define a predictable and well-defined process under which HERA can take steps to exercise certain additional IP rights, to meet clearly defined public health needs,” the trade groups wrote.
 
EFPIA and Vaccines Europe also proposed restricting HERA’s joint procurement facility to the buying of medical countermeasures for a time-limited period in response to EU-wide health emergencies. The trade groups are opposed to the facility replacing national procurement systems. EFPIA and Vaccines Europe also called for the creation of no-fault compensation systems in all Member States, backed by an EU compensation fund, to support patients who suffer serious adverse events.
 
EFPIA NoticeHERA Feedback
 
MHRA moves to new procedure for Urgent Safety Measure notifications
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has moved to a new standard procedure for Urgent Safety Measure (USM) notifications. MHRA switched to the new system for acting to protect clinical trial subjects from immediate threats to their health or safety on Tuesday.
 
USMs are procedures that are not defined by the study protocol but can be enacted immediately to protect participants in clinical trials. Sponsors can adopt USMs without gaining prior authorization from UK regulatory authorities to ensure timely implementation but need to notify MHRA and the relevant ethics committee of their actions.
 
In an update to guidance on managing clinical trials during COVID-19, MHRA said the procedure for USM notifications has changed. The updated guidance links out to another document that explains the new standard notification procedure that took effect this week.
 
MHRA is advising sponsors to call its Clinical Trials Unit to discuss the issue with a medical assessor within 24 hours of measures being taken. That is MHRA’s ideal timeline. At worst, MHRA wants to receive a call within three days of measures being taken.
 
The rest of the guidance sets out what will happen during and after the call. MHRA wants sponsors to be prepared to provide certain information, such as the EudraCT number of the affected trials, the nature of the safety concern and the number of UK subjects currently taking the affected investigational medicinal product.
 
After the call, MHRA expects sponsors to provide written notification of the measures taken and discussed with the medical assessor. Sponsors should submit the written notification by email within three days of taking the measures. MHRA also requires notification of a substantial amendment that covers the changes made to protect patients within around two weeks of the USM notification.
 
If sponsors foresee difficulties meeting the substantial amendment timeline, MHRA wants them to discuss the situation with the medical assessor and agree to a delay during the initial call. Sponsors cannot delay the substantial amendment submission because of “additional changes outside of those taken and required as an urgent safety measure.” MHRA may reject submissions that include “unrelated and unacceptable changes.”
 
MHRA GuidanceMore
 
Ireland’s HPRA posts guide to online controlled drug license system
 
Ireland’s Health Products Regulatory Authority (HPRA) has released a guide to the online application system for controlled drugs. The National Drug Control System (NDS) allows users to apply for import and export licenses for the various schedules of controlled substances in Ireland.
 
Irish law separates controlled drugs into five schedules based on their potential for abuse and therapeutic usefulness. The law places the most restrictions on Schedule 1 drugs, as they are deemed to have a strong potential for abuse and little, if any, therapeutic value. NDS Web is the system people need to use to get import and export licenses for Schedule 1 to 4 substances, as well as for other clearances.
 
The guide walks readers through the process of setting up an account on NDS Web and then using the system to make an application. A separate license or letter of no objection is needed for each consignment. HPRA needs to know if a substance is being imported for re-export.
 
“It is extremely important that the information provided is correct as it will influence Ireland’s and the importing country’s International Narcotics Control Board estimate requirements for that substance for the calendar year. The estimate for each substance is the maximum amount of the substance that the country is permitted to import within that calendar year,” the guide states
 
HPRA is asking applicants not to use NDS Web to request licenses for precursors at this time.
 
HPRA Guide
 
EMA answers questions on integration of veterinary medicine data systems
 
The European Medicines Agency (EMA) has published the questions and answers from a recent webinar on the integration of EudraGMDP and OMS as part of the move to the new veterinary regulatory framework.
 
In the document, EMA clarifies that the changes to EudraGMDP affect both human and veterinary medicines. All organizations with activities managed by EudraGMDP are impacted by the changes, not just marketing authorization holders. Anyone can raise a change request, which needs to happen when an organization in OMS requires updating. Change requests can be sent after 28 January.
 
EMA is advising manufacturers and importers that work with production plants in third countries to liaise with the sites to ensure they are correctly registered in OMS. “It is up to you to coordinate submission of the needed change requests,” EMA said.
 
Q&A Document
 
Other News:
 
Finland is looking to the UK for insights about involving patients in drug research. After hearing from speakers from the UK National Institute for Health Research at a recent event, the Finnish Medicines Agency (Fimea) outlined how their work can inform changes in Finland. Fimea Notice (Finnish)