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Regulatory Focus™ > News Articles > 2020 > 9 > Euro Roundup: MEPs seek more power for EMA to address shortages

Euro Roundup: MEPs seek more power for EMA to address shortages

Posted 24 September 2020 | By Nick Paul Taylor 

Euro Roundup: MEPs seek more power for EMA to address shortages

Members of the European Parliament (MEPs) have voted overwhelmingly to give the European Medicines Agency (EMA) “a broader mandate and increased resources” to address supply disruptions from shortages of medicines.
 
The text, which MEPs adopted by 663-23, with 10 abstentions, calls for the European Commission and EU member states to address drug shortages from multiple angles, some of which involve passing regulations and empowering EMA.
 
“In the long term, EMA should be able to deliver marketing authorizations subject to the fulfilment of supply and accessibility requirements on the part of manufacturers, without such requirements leading to a shortage of medicines,” according to the text.
 
The text notes that MEPs would like “the reinforcement of EMA’s resources” to equip the agency to “maintain the current system of inspecting production sites established in third countries via coordination of the national inspectors.”
 
MEPs also want EMA to supervise a planned forum of policymakers, regulators, payers, patients and drugmakers designed to prevent shortages, address the sustainability of the pharmaceutical supply chain and ensure the competitiveness of the European industry.
 
In the text, MEPs also seek to reduce the EU’s reliance on foreign companies for active pharmaceutical ingredients (APIs) and finished products. That effort, which could benefit from the supply disruption caused by COVID-19, will be backed up by new regulations if the Commission enacts the vision set out by MEPs.
 
“These strategies must include regulatory measures and encourage the production of essential APIs and medicines in Europe with the aim of making medicines available, affordable, sustainable and equally accessible,” the text states.
 
The MEPs also asked the Commission and Member States to consider creating “procedures under which contracts may be awarded to a number of successful tenderers, including joint tenderers, by focusing on production in the EU and guaranteeing at least two different sources for the basic substance.” The MEPs want a legislative framework that encourages healthcare systems to carry out tenders that reward “companies that guarantee the supply of pharmaceuticals in difficult circumstances.”
 
How much, if any, of the text might shape actual policies depends on the Commission and Member States. Parliamentarians see the upcoming pharmaceutical strategy as an opportunity for the Commission to put some of their ideas in practice.
 
Adopted Text, Press Release
 
EU Parliament calls for law to increase supply chain transparency
 
The European Parliament is pushing for a “strong legislative framework” that increases transparency of the entire drug supply chain, based on a resolution passed by MEPs last week (671-15, with 10 abstentions).
 
MEPs called for the Commission to set up a secure, centralized database that stores the results of environmental risk assessments of products. The call reflects a belief that transparency is needed given the impact pharmaceuticals can have on “water, environmental behaviour, degradability and possible cocktail effects.”
 
MEPs want to create a legal basis for more transparency, arguing that a strong legislative framework is required to “allow proper scrutiny and ensure that companies are held to account for the environmental release of pharmaceuticals.” The text also calls for the pharmaceutical industry to be more transparent, specifically by disclosing the origin of drugs and APIs “at raw material production stage.”
 
The text could lead to changes in how medicines are approved. MEPs want the environmental impact of human medicines to be factored into benefit/risk assessments. However, it is unclear what effects the change would have given the MEPs are also opposed to changes that delay approvals or lead to drugs being rejected solely on environmental grounds.
 
The adopted resolution will now go to the Commission and European Council.
 
Adopted Text, Press Release
 
Swissmedic guidance aims to fast track COVID authorizations
 
The Swiss Agency for Therapeutic Products (Swissmedic) plans to give companies “maximum flexibility” and fast track its decisions about vaccines and therapeutics against COVID-19.
 
Swissmedic set out its position in an updated version of pandemic guidance first released in 2012. The update refocuses the guidance on COVID-19, adding a new section on the measures Switzerland adopted to combat the coronavirus.
 
The measures list four active ingredients — hydroxychloroquine, lopinavir/ritonavir, remdesivir and tocilizumab — that can be placed on the Swiss market while Swissmedic is still reviewing a filing for authorization. Manufacturers of the substances can implement variations immediately after sending an application about the changes to Swissmedic.
 
Elsewhere, the guidance states Swissmedic can “approve deviations from the relevant provisions of therapeutic products legislation on the basis of a benefit/risk analysis for medicines used to prevent and combat COVID-19.” The comment relates to product information texts and packaging, which the Swiss regulator discussed in more detail in a separate update.
 
Swissmedic Notice
 
MHRA creates National Patient Safety alerts to communicate critical issues
 
Safety-critical alerts for medicines and medical devices in the UK will be communicated via National Patient Safety alerts, according to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
 
The alerts will follow criteria and a template agreed by the National Patient Safety Alerting Committee, according to the agency. The approach appears designed to ensure alerts about safety-critical information reach and are acted upon by the appropriate people at healthcare organizations.
 
Alerts will “explain risk clearly and effectively” and “have required actions that have been assessed for feasibility, safety, efficacy and cost-effectiveness,” according to MHRA. They will be designed to be “quickly recognized and actioned by senior personnel.”
 
Issues that fall short of the definition of safety critical will continue to go out under the old format and process for now, until MHRA has held a consultation on the best way to handle them.
 
MHRA Notice
 
Other News:
 
MHRA is working to increase accessibility to its documents by converting their format from PDF to HTML, starting with the content that is viewed the most and needed for using a service. MHRA will not convert all documents published in the past on the grounds the cost of doing so would impose a disproportionate burden on it. MHRA Notice
 
MHRA is strengthening the warnings on over-the-counter opioids to make clear that the products can cause addiction and withdrawal symptoms. The change comes around 18 months after the UK began a review into the benefits and risks of opioids. MHRA Notice

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