EU Regulatory Roundup: MHRA Starts Sharing Intel With India to Curb Imports of Unlicensed Drugs
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.EMA Reports Double-Digit Decline in Use of Veterinary Antimicrobial Agents
The European Medicines Agency (EMA) has reported a double-digit decline in sales of veterinary antimicrobial agents across 30 countries in the region. Overall, use of the products in food-producing animals fell by more than 20% between 2011 and 2016.
The downward trend was driven by sharp declines in the use of antimicrobials that the World Health Organization has identified as high priority, critically important products for human health. Sales of polymyxins fell 40% from 2011 to 2016, while use of quinolones and third- and fourth-generation cephalosporins dropped by around 15%.
Those upbeat headline findings mask some ongoing difficulties and country-to-country differences, though. When adjusted for the size of the animal population to give a figure per population correction unit (PCU), sales of cephalosporins increased in 13 countries. Almost as many countries increased their use of quinolones and polymyxins.
The divergent trends are part of a broader dataset that reveals dramatic differences in the use of antimicrobials across the European Union and affiliated countries. In 2016, use of veterinary antimicrobial agents in food-producing animals ranged from 2.9 mg per PCU in Norway up to 453.4 mg per PCU in Cyprus. Two-fifths of countries used less than 50 mg per PCU, but some used far more. Cyprus was one of eight countries to use more than 100 mg per PCU.
The wide range of values stems from large differences in antimicrobial use at the start of the reporting period. However, the data also reveal divergent trends over the reporting period. While use of drugs has trended down in many countries, others administered record levels of antimicrobials in 2016.
The 453.4 mg per PCU used by Cyprus is the most administered by any country over the seven-year period, and is 16% more than the Mediterranean island itself used as recently as 2014. Bulgaria, Greece and Portugal used record amounts in 2016, too, and Ireland, Poland, Slovakia and Spain all administered more than that at the start of the reporting period.
Given the lag in the publication of the data, it is unclear how EMA’s efforts to curb antibiotic use over the past two years have affected practices in these countries. The agency has evidence that change is possible, though. While Hungary and Italy continue to use more antimicrobials than many other EU countries, the amounts fell by and 31% and 30%, respectively, from 2010 to 2016.
Provisional explanations for the downward trends include the the implementation of responsible-use campaigns and the setting of targets. EMA sees ample scope for antimicrobial use in Hungary, Italy and other countries to continue decreasing toward the sub-50 mg per PCU levels seen in many parts of the EU.
However, the agency’s ability to encourage countries to make those changes could be hamstrung by Brexit. EMA is trying to protect its antimicrobial resistance activities from Brexit-enforced cuts. While EMA is retreating from most international cooperation and suspending expert groups, it has spared activities related to antimicrobials for now. That could change, though, and EMA is already warning that its involvement in international resistance activities will be “downsized as considered necessary.”
EMA Report
MHRA Starts Sharing Intel With India to Curb Imports of Unlicensed Drugs
The United Kingdom has begun sharing intelligence with India to try to stop the supply of unlicensed drugs at their source. UK officials think the intelligence will help the Indian Directorate of Revenue Intelligence (DRI) to target regions suspected of shipping unlicensed medicines to Europe.
India is a key hub in the illegal medicine trade. For the past three years, India has shipped more drugs suspected of infringing upon intellectual property rights into the EU than any other country, according to data on border seizures. Some of the seized products were destined for the UK. Other shipments likely avoid detection at the border and enter the country.
The Medicines and Healthcare products Regulatory Agency (MHRA) wants to stop drugs making it to the UK. With that goal in mind, MHRA has agreed to share intelligence with DRI, the Indian body that investigates smuggling.
DRI has already had some success stopping shipments at their source. MHRA cites the DRI seizure of 350,000 sedatives and painkillers destined for Europe and the United States as an example of the role the Indian agency is playing. By quickly sharing intelligence under existing bilateral agreements, MHRA thinks it can help DRI seize more unlicensed medicines before they leave India.
MHRA Notice
HMA Updates Brexit-Related Veterinary Pharmacovigilance Advice as Exit Approaches
The Heads of Medicines Agencies (HMA) has updated its advice about Brexit to the veterinary medicine industry. HMA’s update covers where the deputies to qualified persons for pharmacovigilance (QPPV) can live and how Brexit will affect the status of inspection outcomes reached by MHRA.
Earlier advice from HMA’s Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) stated QPPVs must live and work in the European Economic Area (EEA), not UK, after Brexit. However, CMDv’s question and answer document lacked information about the deputies to QPPVs. The latest version addresses that gap.
Deputies to QPPVs must also live and work in the EEA. CMDv’s position reflects the fact that QPPVs delegate tasks to deputies. As deputies perform some of the same work as QPPVs, CMDv wants them to be registered in EudraVigilance Veterinary and subject to the same rules as qualified persons.
The QPPV is one of two new questions addressed by CMDv. The second question allowed CMDv to set out how Brexit will affect the status of inspection outcomes reached by MHRA.
“It is expected that findings of inspections, in particular to determine compliance with good manufacturing practice, good clinical practice and pharmacovigilance obligations, conducted by the UK competent authority before 30 March 2019 are implemented by the inspected entities in accordance with the applicable legislation,” CMDv wrote.
HMA Q&A
Danish Regulator Creates 2-Year Transition Period to Ease Impact of Brexit
The Danish Medicines Agency (DKMA) will allow manufacturers to sell packs that list a UK marketing authorization holder (MAH) for two years after Brexit. The transition period will ensure MAHs can sell products made before Brexit in Denmark after the UK leaves the EU.
In theory, products that feature the details of UK-based MAHs could be refused entry to EU markets after the country leaves the EU in March. DKMA is taking a softer line, though. If DKMA has approved a name or address change for a MAH before 30 March, the company will be able to continue selling packs that list the old UK details.
The establishment of the transition period means MAHs will not need to withdraw packs that feature the old labeling. DKMA is giving MAHs until 29 March 2021 to sell off packs with the outdated labels.
There are some limitations to the flexibility shown by DKMA. MAHs must replace the online version of their package leaflets with the post-Brexit versions within three months of receiving approval for the changes. The transition period does not apply to qualified persons (QPs). After 29 March, QPs will not be permitted to release batches that list UK-based MAHs on the packaging materials.
DkMA Notice
Other News:
Ireland’s Healthcare Products Regulatory Authority (HPRA) has revised its guide to post-authorization notifications. HPRA Guide