Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EU Committee Pressures Commission to Create Europe-Wide Drug Pricing Initiatives
The European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) has called for continent-wide initiatives to improve access to medicines. In a draft report, ENVI takes the biopharma industry to task for prioritizing profits, not patients, when making research decisions and calls on the European Commission to take action to address the perceived imbalance.
As Soledad Cabezón Ruiz, the report’s writer, and her colleagues at ENVI see it, decades of regulations that have focused more on safety than “financial matters and innovation quality” have led to drug developers failing to serve patients in terms of their research priorities, the prices they charge and their approach to generic competition. With national healthcare systems in the European Union struggling to afford new drugs, Ruiz thinks the situation is conflicting with the right to access medical treatment that is enshrined in the laws governing the region.
“The individual member states and the commission have taken timid measures without any kind of coordination, which has fragmented the market even more and generated inequality in access to medicines for European citizens,” Ruiz wrote. “The system needs to be reviewed, as does its regulation, to strike a balance between public and private interests, the sustainability of health care systems and the right everyone has to health protection, guaranteeing research incentives as well as individuals’ interests and their right to better health care standards.”
To get the review started, ENVI has fired off 20 recommendations for the commission to implement to fix the perceived failings of the current model. Several of the recommendations advocate a more centralized approach to drug pricing. ENVI is calling for legislation on health technology assessments, harmonized pricing and reimbursement criteria, the sharing of information on prices, reimbursement and negotiation agreements between countries, the creation of a price-monitoring task force and the establishment of commission-coordinated joint procurement programs.
In parallel to changes to the pricing and procurement of drugs, ENVI wants the commission to act to refocus drug development priorities. The intention is to “promote R&D driven by patients’ needs,” something Ruiz thinks the commission can achieve by funneling a share of pharma industry profits into an EU public platform for R&D. Other changes proposed in the report include the overhaul of orphan drug regulations, the establishment of a framework that cuts the time it takes for generics to enter the market and greater transparency of R&D costs.
The focus of the report is, in part, a reflection of the politics of Ruiz, who is member of the Spanish Socialist Workers' Party. As such, it is likely some of the recommendations will be challenged as more business-friendly politicians start to shape the progress of any review of the current system.
EMA Names new Head of Human Medicines Research and Development Support
The European Medicines Agency (EMA) has named Enrica Alteri as the head of human medicines research and development support. Alteri, who worked at Merck Serono before joining the regulator, replaces Zaïde Frias as the head of the group that provides scientific advice to drug developers.
In Alteri, EMA has gained a department leader with significant experience heading up units at the regulator and working at the sorts of companies to which she will now offer scientific advice. Alteri joined EMA in 2012 as head of safety and efficacy of medicines, before going on to take up the position of head of human medicines evaluation the following year. Before joining EMA, Alteri worked at drug developers including Merck Serono and Novartis.
Alteri took up the new position in time to attend the first EMA-EFPIA annual bilateral meeting in her new capacity on 16 September. Frias, the person Alteri replaced, was also at the meeting with the European Federation of Pharmaceutical Industries and Associations (EFPIA). Frias has taken up Alteri’s former role as head of human medicines evaluation, putting her in charge of ensuring the timely, quality review of submissions.
Frias is joined on the human medicines evaluation team by Jordi Llinares Garcia, who used to work with her at the human medicines research and development support unit. Garcia has swapped jobs with Michael Berntgen, giving him oversight of scientific and regulatory management at the human medicines evaluation group. Berntgen, who has spent the past decade working as a regulator at EMA and in his native Germany, has replaced Garcia as head of product development scientific support.
EMA Leadership, More
AstraZeneca’s Tagrisso Becomes First Drug to Benefit from Reformed NICE-CDF Relationship
The United Kingdom National Institute for Health and Care Excellence (NICE) has recommended the first drug through its new relationship to the Cancer Drugs Fund (CDF). NICE’s recommendation of the lung cancer drug Tagrisso means AstraZeneca can sell it through CDF while gathering more data.
After originally existing to pay for cancer drugs NICE viewed as offering poor value to the healthcare service, CDF was reformed earlier this year to open up the option of conditional recommendations. The reimbursement pathway allows NICE to make a conditional recommendation when it lacks data to show a cancer drug is cost effective. Drugs that receive such tentative support will be paid for by CDF for up to two years while their manufacturers collect more data to support full reimbursement.
NICE adopted the new way of working on 1 April, but took until this week to make its first conditional recommendation. The equivocal recommendation means AstraZeneca's Tagrisso is available today as a second-line treatment in EGFR T790M-positive patients with advanced non-small-cell lung cancer. If AstraZeneca is to gain a full recommendation, it must enhance its submission and convince NICE of the drug’s value during a shortened review.
The NICE committee wants to see results that show what it sees as the early promise of Tagrisso is likely to translate into long-term benefits that justify its price tag. AstraZeneca tried to provide such results in its initial filing in May and with additional data it added at a later date, but was unable to persuade NICE to offer anything more than a conditional recommendation.
CHMP Adopts Guidelines on Immunoglobulin Summaries of Product Characteristics
The Committee for Medicinal Products for Human Use (CHMP) has adopted final guidelines on the core summary of product characteristics (SmPC) for certain immunoglobulins. CHMP adopted the guidelines after reviewing feedback from the two groups to comment on the draft texts.
EMA’s CHMP put the guidelines on anti-d immunoglobulins for intramuscular and intravenous use out to comment in February. Sanquin Plasma Products commented on the intramuscular text and the International Plasma Fractionation Association (IPFA) submitted feedback on both drafts. However, the comments were mostly overruled by CHMP and the Blood Products Working Party, resulting in the texts that will come into effect on 1 April being largely the same as the earlier drafts.
The regulator accepted a suggested IFPA change to the structure of a paragraph regarding antenatal prophylaxis that was repeated in both drafts, and another from Sanquin about the wording of a sentence. IFPA also persuaded CHMP to change a section on precautions for use of immunoglobulins intravenously and intramuscularly, although officials rejected most of the suggested revisions to the section. CHMP only agreed to remove a reference to patients of advanced age.
Intramuscular Guideline, Comments, Intravenous Guideline, Comments