Euro Roundup: EFPIA warns proposed legislation will gut industry

Proposed legislation from the European Commission (EC) would “irretrievably sabotage” the pharmaceutical industry and “send Europe to the back of the queue for healthcare treatments, clinical research, jobs and global investment.”
 
That’s the reaction of the European Federation of Pharmaceutical Industries and Association (EFPIA) to a leaked draft of proposed EC pharmaceutical legislation.
 
“Whether it is naivety, blind optimism or a more conscious decision for Europe to rely on innovation from the US and Asia, there should be no doubt that in its current form, this proposed legislation will be extremely damaging to the competitiveness of Europe’s industry and to our region’s strategic autonomy,” Natalie Moll, EFPIA director general, said in a statement. “It will have a negative impact on jobs, investment, the European research ecosystem, growth, patient access to new clinical trials and availability of the latest treatments for decades to come.”
 
Moll went on to say that “leading companies are reporting difficulties in researching and developing medicines and vaccines in Europe,” pushing them to plan to move operations elsewhere. EFPIA has hit the same theme in the past, citing data on changing patterns of R&D spending over the past 30 years to make its case. In 1990, Europe received more pharma R&D investment than the US, according to EFPIA. By 2020, Europe was a distant third, trailing more than €30 billion ($32 billion) behind the US and China.
 
EFPIA sees the pharma legislation as a once-in-a-generation opportunity to create “a future-proof, innovation-minded regulatory framework, and a world-class, robust and predictable intellectual property ecosystem.” The trade group accepts the need to “improve the significant variance in accessing new medicines across Europe,” pointing to its own activities toward that goal while noting the fact that the EU cannot fix the problem through legislation. National governments will need to contribute.
 
The stated goals of the pharma legislation differ significantly from EFPIA’s interpretation of its potential effects, with the Commission drafting the proposals to foster innovation, including in areas of unmet medical need, adapt to new scientific and technological developments and reduce red tape.
 
EFPIA Statement
 
MDCG clarifies medical device vigilance terms and concepts established by new regulation
 
The Medical Device Coordination Group Document (MDCG) has answered questions about the vigilance terms and concepts used in the Medical Device Regulation (MDR) in a new guidance document.
 
EU officials established definitions for some medical device vigilance terms through guidance that was in force under the old directives and was last updated in 2013. MDCG has reused some definitions from the earlier guidance, modifying them as needed to align with MDR, and answered a set of questions about the implications of terms used in the new regulation.
 
The Q&A explains the difference between an “incident” and a “serious incident,” which rests on the risk of significant health or public health outcomes and the implications for MDR reporting responsibilities. The coordination group has created a flowchart to walk manufacturers through the process of evaluating an incident.
 
MDCG covers the basic reporting criteria for a serious incident in another question, explaining each of the three requirements in detail, and goes on to explain how incidents can “indirectly lead to a serious deterioration of health.” Examples of indirect harm include inaccurate and delayed diagnoses and failure to provide appropriate, timely treatment. The 18-page document covers multiple other topics.
 
MDCG Document
 
EMA calls for scientific data to inform cannabis monographs, answers queries about regulation
 
EMA’s Committee on Herbal Medicinal Products (HMPC) has called for the submission of scientific data to support the assessment of Cannabis sativa flowering tops and the development of monographs for the herbal product.
 
The HMPC assessment will evaluate the medicinal use of the flowering tops. Other Cannabis-derived products or substances, such as isolated constituents, are excluded from the review. HMPC wants data on well-established medicinal uses, defined as used for at least 10 years in the EU, and evidence that the flowering tops have traditional medicinal uses dating back at least 30 years.
 
Noting the “general high public interest in Cannabis-derived products beyond the medicinal framework,” HMPC reiterates the limited scope of its assessment in an annex that explains the type of data it can and cannot accept. HMPC is accepting submissions until 14 May.
 
HMPC also published answers to questions on Cannabis-derived medicinal products and the scope of EU herbal monographs. The Q&A explains that Cannabis-derived substances that meet the definition of a medicinal product must comply with the requirements of the EU pharmaceutical law and “must obtain a marketing authorization from a Competent Authority before they can be placed on the EU market, like any other medicinal product.”
 
EMA Notice, More
 
PRAC starts review of cold and flu medicine after reports of reduced blood supply to the brain
 
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety of medicines that contain pseudoephedrine in response to reports of conditions that can reduce blood supply to the brain.
 
Pseudoephedrine is used to relieve nasal or sinus congestion caused by a cold, flu or allergies. Products already carry warnings about the risk of cardiovascular and cerebrovascular events. Now, reports in pharmacovigilance databases and the medical literature suggest the drug may cause other side effects.
 
PRAC has seen “a small number” of cases of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome, conditions that affect blood vessels in the brain and can reduce blood flow. The seriousness of the cases has prompted PRAC to consider whether EU marketing authorizations for pseudoephedrine should be maintained, varied, suspended or withdrawn. France’s National Agency for the Safety of Medicines and Health Products requested the review.
 
EMA Notice
 
MDCG explains process for determining if an IVD is a companion diagnostic in guidance update
 
MDCG has updated its guidance on the rules for classifying in vitro diagnostics (IVDs) under the new regulation. The main change is the addition of an annex that explains the process for determining if an IVD is a companion diagnostic.
 
The annex features a flowchart that poses four questions. To be classified as a companion diagnostic, an IVD must be essential to the safe and effective use of a medicinal product and not be used to check if the concentration of the medicinal product is within the therapeutic window or determine the dose. The IVD also must identify patients likely to benefit from a drug or suffer serious adverse events.
 
MDCG also revised an existing section of the guidance that discusses devices intended to be used as companion diagnostics and made more minor changes to other parts of the text.
 
MDCG Guidance