Posted 02 July 2015
By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top regulatory news in Europe.
Commission Under Fire for Delay in Implementing Falsified Medicines Legislation
Consumer groups have criticized the European Commission over the time it is taking to implement the falsified medicine legislation. The law came into force in 2011, but the commission is yet to provide details that are needed to create the coordinating national structures.
A small piece of the program was put into place last month with the naming of data service providers, but the commission is yet to release the “delegated acts” that will define which products are covered and the process for checking authenticity. The commission told Politico the agenda is on schedule and the acts are due to be adopted later this year, but the argument has done little to appease those who think it should have moved faster given the risks posed by falsified medicines.
“It is unacceptable that after four years the legislation is still not implemented and that we will have to wait even more to see some tangible effects of the law in real life,” Ilaria Passarani, health policy officer at consumers association BEUC, said. Even once the delegated acts are approved, the law will not come into effect for three years. The lag has raised fears that patients will suffer in the interim or that member states will create a patchwork of national systems instead of a Europe-wide network.
Pharma Frets over Grexit Threat to Drug Supply in Greece
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has communicated its worries about the effect of Greece exiting the Eurozone on the drug supply chain. Leaders at the trade group fear the reintroduction of the drachma currency could create a discrepancy between the prices of medicines in Greece and the rest of Europe, leading to a surge in parallel trade.
In a letter to the European Commission seen by The Financial Times, Richard Bergström, EFPIA director-general, presented the scenario as a threat to the availability of medicines in Greece. The hypothesis is that a change in currency would see the price of medicines in Greece crash, creating a situation in which it is highly profitable to export the products to other European countries. Such parallel trade is allowed in Europe but is a long-standing grievance of the pharmaceutical industry.
Bergström told the commission drugmakers are trying to mitigate the shortages that could occur if Greece exits the Eurozone and its supply chain infrastructure breaks down, but competition laws are preventing them from coordinating their responses. EFPIA wants the European Union to take action to stop the diversion of drugs from Greece to other countries. Such diversions and other supply chain consequences of Grexit would affect EFPIA members financially.
The Financial Times, Reuters
MHRA Plans Changes to Medical Device Funding Model
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has proposed revising its funding model for medical devices. MHRA is considering the changes to ensure it can sustain the financial burden of regulating the industry over the long term.
Money for MHRA’s device activities currently primarily comes from the Department of Health, but funding has dried up over the past decade. With MHRA calculating that its funding for devices has halved in real terms since 2003 — and incidence of adverse event reporting has risen 50% since 2009 — the regulator has decided a new approach is needed. The goal is to create a model that will allow MHRA to recoup its costs in the 2016/17 financial year.
To achieve this objective, MHRA plans to implement a new periodic fee, make changes to existing fees and pull in minor funding from the government. The Department of Health is to help MHRA over the next year by providing £8.1 million ($12.6 million), plus £1 million for efficiency initiatives, but in the longer term the regulator will lessen its reliance on this traditional source of funding. This shift is a top strategic priority for MHRA over the coming year.
Business Plan, Press Release
Talk of EU Collaboration on Drug Pricing Intensifies
More prominent European officials have proposed extending the powers of the EU into new areas, such as pricing and access to medicines. The arguments in favor of such a shift have advanced over the past year as member states have sought novel ways to control the cost of medicines.
Politico reports Jo De Cock of Belgian social security body RIZIV made the most outright call for such a change by backing a more integrated approach to pricing at a European level. “Why not cooperation between member states — let me be very clear — not in order to organize joint procurement but to try to think together,” De Cock said. The commission, for its part, has steered clear of pricing and reimbursement but will discuss the topic with the council later this month.
The topic is a tricky one for the commission, with some member states resistant to any perceived loss of powers to Europe. However, there is a clear move at high levels in Europe to rethink how the EU should approach health. “I believe it will be nice to discuss the possibility to change the European Union treaties in the future,” Vytenis Andriukaitis, the European commissioner for health, said at the Riga conference on Universal Health Care: Investing in Wellbeing for All.
The European Commission has maintained its stance that Ireland should reduce its spending on prescription drugs despite criticism from the industry. The Irish Pharmaceutical Healthcare Association was unhappy with the commission’s involvement and communicated its grievances, but European officials have reportedly rebuffed the criticisms. The Irish Times
The Committee for Medicinal Products for Human Use (CHMP) has recommended 10 new drugs for approval. CHMP gave its support to a pair of enzyme replacement therapies and the first histone deacetylase inhibitor for the treatment of multiple myeloma. CHMP rejected one drug, the advanced therapy medicinal product Heparesc. Press Release
The European Medicines Agency (EMA) has called for better training tools for patients using adrenaline auto-injectors. EMA issued the recommendation after a review raised concerns that patients may currently be injecting under the skin instead of into the muscle, resulting in it taking longer for the adrenaline to take effect. Press Release
MHRA has posted advice for physicians to follow when prescribing SGLT2 inhibitors, the class of diabetes medicines that have been linked to high levels of blood acids. The advice to test for raised levels of ketones in patients with symptoms of acidosis, even if plasma glucose levels are OK, comes weeks after EMA began a review into the safety of the medicines. MHRA Statement
EMA has released a draft reflection paper on the viral safety of plasma-derived products. The paper is focused on hepatitis E virus, infection with which is often asymptomatic. This characteristic of the hepatitis E virus makes it of particular concern to EMA. The reflection paper is a step toward setting up more rigorous processes to stop transmission via plasma-derived products. Reflection Paper
It is now mandatory for companies to use electronic forms when making centralized marketing authorization applications. The deadline for adopting electronic forms passed on July 1. In conjunction with the change, EMA prohibited companies from sending applications to member states on DVDs or via the Common European Submission Platform. Press Release, More