Posted 09 March 2017
By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Starts Risk-Based Inspections of Online Pharmacies After Finding bad Actors
The United Kingdom has initiated a risk-based inspection program targeting online pharmacies and healthcare service providers. Officials at the Care Quality Commission (CQC) began the operation after urgent inspections of two digital providers of primary care and a review of 43 other services raised concerns that online operators threaten the safety of patients.
CQC, the regulator of health and social care in England, began looking into the sector following a report by BBC radio about the online sale of antibiotics. That led to urgent inspections of MD Direct and HR Healthcare, the organization at the center of the BBC report.
Now, CQC has revealed the outcome of the inspections and joined with three bodies, including the Medicines and Healthcare Products Regulatory Agency (MHRA), to issue a statement about online pharmacies and healthcare services.
CQC inspections seek to ascertain if a service is safe, effective, caring, responsive to people’s needs and well-led. MD Direct and HR Healthcare failed to meet CQC expectations in some of these areas, leading the former to voluntarily cancel its registration and the regulator to suspend the registration of the latter. The actions followed discoveries of practices that threatened patient safety, including the sale of unlicensed medicines and inappropriate prescribing practices.
“One patient was prescribed four courses of seven days each of an antibiotic for urinary tract infections. This was inappropriate as the patient should have been referred for further investigation. Another patient was prescribed 12 asthma reliever inhalers over a four-month period. There was a risk a person may suffer a life-threatening exacerbation of asthma because they were not being appropriately reviewed in response to their high usage of reliever inhaler,” the inspectors of HR Healthcare wrote in their report.
CQC is working with MHRA and two other regulatory bodies to monitor the online health sector, notably by sharing information. Responsibility for further inspections falls on CQC. The regulator has reviewed all 43 online services registered to practice in the UK and established an inspection program dictated by which sites appear to pose the greatest risk to patients.
MHRA and CQC issued their joint statement days before politicians met in the House of Commons to discuss the review Jim O'Neill conducted into antimicrobial resistance. Tighter regulation of the online sale of antibiotics was on the agenda, although there are questions about how committed the current government is to addressing antimicrobial resistance.
Talking to Politico, O’Neill said the government that emerged after David Cameron resigned as Prime Minister following the Brexit vote is less engaged with the topic than the previous administration. O’Neill spoke directly to Boris Johnson about antimicrobial resistance, but came away with the impression the foreign secretary “seemingly shows no interest” in continuing the work started under Cameron.
Press Release, Debate Transcript, Politico
Swissmedic Names India as Main Source of Illegal Drug Imports for Fifth Year Running
The Swiss Agency for Therapeutic Products (Swissmedic) has named India as the main source of illegal drug imports for the fifth consecutive year. In 2016, almost half of the 1,028 illegal imports of therapeutic products seized in Switzerland originated in India, cementing the country’s status as the primary source of confiscated shipments.
Over the past five years, the proportion of illegal imports originating in India has risen steadily. In 2012, Swissmedic reported 30% of confiscated medicinal product shipments originated in India, only three percentage points more than came from Western Europe. Last year, 48% of confiscated shipments came from India, more than twice as many as originated from Western Europe. Aside from a small dip in 2015, India’s share has increased each year since 2012.
Swissmedic has previously attributed the rising proportion of illegal imports originating from India to better enforcement in Europe. This, Swissmedic claimed in 2015, is forcing illegal distributors to switch to India “where the authorities are obviously taking very little action.” Imports from other Asian countries and Eastern Europe have remained steady, with the 13% share of the former the lowest it has been over the past five years.
The Swiss regulator made little comment about the countries of origin of illegal shipments in its latest update, focusing instead on the types of product coming into the country. Erectile dysfunction drugs continue to account for more than half the market — as they have since 2014 — but in other areas the mix is shifting.
Of particular concern to Swissmedic is the rise in confiscations of treatments for acne, albeit from a low base. Some of the seized shipments contained isotretinoin, the active ingredient in an acne drug that can harm unborn children. Many of the drugs seized by authorities, across all classes of medicine, lacked cartons and package inserts to warn patients about side effects and advise on the correct dose. Some products had quality defects. Incorrect levels of active ingredient — either too much, too little or none at all — were commonly detected.
EMA Starts Consultation on Quality of Water for Pharmaceutical use
The European Medicines Agency (EMA) has begun a consultation on the quality of water for pharmaceutical use. EMA thinks the existing guideline needs updating to reflect incoming revisions to the European Pharmacopoeia and the diversification of processes to make water of injectable quality.
Officials from EMA’s human and veterinary medicines committees detailed the need to update the guideline in a draft concept paper. Since EMA introduced the current guideline in 2002, the European Pharmacopoeia has revised its monograph on water for injections and is set to delete its monograph titled Water, highly purified.
The changes to the monographs reflect the use of processes other than distillation to produce water of injectable quality. Use of techniques deemed equivalent or superior to distillation, such as reverse osmosis followed by ultrafiltration, are now permitted by the European Pharmacopoeia. This brings the European Pharmacopoeia closer to practices in Japan and the United States, but makes it out of step with EMA guidance.
EMA began the process of closing the gap last year with the publication of a draft question and answer document on reverse osmosis, biofilms and control strategies. The draft concept paper builds on that earlier document by confirming EMA’s intent to follow the European Pharmacopoeia’s lead, while also using the revision as an opportunity to consider amendments to the requirements of water quality of different grades.
The regulator is accepting feedback on the draft until 6 June and plans to have revised draft guidance ready for consultation in October.
The Committee on Herbal Medicinal Products (HMPC) has called for scientific data on therapeutic uses of herbal tea combinations. HMPC wants to see data on the use of teas in three therapeutic areas to support its work on herbal monographs and European Union list entries. The regulator is accepting submissions until the end of May. Loss of Appetite, Digestive Disorders, Nervous TensionsEMA is holding a meeting next week on the role patients and healthcare professionals can play in the development of regulatory approaches that support the advance and evaluation of personalized medicines. The Patients’ and Consumers’ Organisations Working Party and Healthcare Professionals’ Organisations Working Party are jointly holding the meeting. EMA Notice