European Regulatory Roundup: Commission Posts Draft of Key Falsified Medicines Directive Regulation (20 August 2015)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Commission Posts Draft of Key Falsified Medicines Directive Regulation

The European Commission has released draft rules for the implementation of safety features as part of its preparations for the rollout of the Falsified Medicines Directive (FMD). If everything goes to plan, the draft will be finalized early in 2016 and come into force three years later, ending the long wait for the adoption of requirements laid out in the directive, Securing Industry reports.

For those tracking the progress of the FMD, the release of the document is a big, eagerly-anticipated event. Now, for the first time, the industry knows for sure how the commission foresees technical and organizational aspects of the FMD being implemented. Much of the document is as expected. The commission is proposing the use of 2D barcodes to identify products, giving the industry a way to access the serial number, product code, batch number and expiry date of each unit.

SecurPharma, a German group affiliated to to the European Medicines Verification System (EMVS), has welcomed the draft, calling the proposal "well described and on track." The draft is in keeping with the model outlined by EMVS, which was set up by representatives of the biopharma industry and other sectors affected by the FMD. Both the draft and EMVS advocate putting stakeholders in charge of repositories housing unique identifiers and giving member states access to the resource.

The document is open for comments until 11 October. Officials at the commission are hoping to have a version on which the European Parliament and Council agree ready for publication early next year. Once the finalized text is published in the Official Journal of the EU, a three-year countdown to the date on which it will come into force will start. The lag between the passing of the FMD and its requirements coming into force has come in for criticism in recent months. 

Securing Industry, Commission Draft

EU Working to Thaw Relations with India Following Spat over EMA ban

Officials in the European Union are working to improve relations with their peers in India in the wake of the breakdown in trade talks. India pulled out of the negotiations in protest against the European Medicines Agency (EMA) ban on drugs tested by GVK Biosciences, but parties on both sides of the table are now hopeful of finding a resolution to the standoff, Reuters reports.

Negotiations over a trade deal were due to resume after a two-year hiatus later this month, only for India to pull out. The Indian government made the decision in response to the ban on drugs tested by GVK, and particularly the failure of the EU trade commissioner to respond to a letter sent by the office of Prime Minister Narendra Modi. The EU Trade Commission says it never received the letter, but the overall tone coming out of Europe is conciliatory.

"The Commission hopes that a solution will be found to the current deferral," Daniel Rosario, a spokesman at the European Commission, told Reuters. An Indian official anonymously said the same thing, telling the newswire the government's action "is not a permanent deferral." Last time India tried tough negotiating tactics it won farm subsidy concessions from the World Trade Organization, but European officials are yet to publicly soften their stance on the GVK ban.

Reuters

MHRA Issues Another Warning About Roche Blood Glucose Monitoring System

The United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has issued another warning about a blood glucose monitoring system sold by Roche. MHRA posted the latest notice because users are still receiving false high glucose readings from their Accu-Chek devices.

Roche and MHRA have alerted users of Accu-Chek devices about multiple issues over the past year, from the risk of incorrect results when taking the antibiotic ceftriaxone to the need to follow testing procedures to avoid falsely high readings. MHRA warned patients of the need to follow instructions in June 2014, but it seems the message is yet to reach every user, with the regulator noting that it continues to receive reports of falsely high blood glucose readings.

In response, MHRA has issued another release asking healthcare professionals to ensure patients who use the device understand the testing workflow and know what to do in the event of a reading outside their normal range. False glucose readings can occur when patients fail to clean and dry their hands before testing, or when the blood droplet is applied incorrectly. The process is different to the one followed for glucose testing strips.

MHRA Alert

Campaigners Call for HRA to Maintain Transparency Push in Wake of Legal Challenge

Campaigners in the United Kingdom have called on the Health Research Authority (HRA) to maintain its push for greater transparency in the wake of an unsuccessful legal challenge by a clinical research unit. The groups fear HRA may think the views of the challenger are representative of the industry.

To offset the chance of HRA reaching such a conclusion, the Ethical Medicines Industry Group (EMIG) and Sense About Science have written to the UK state organization to outline what they see as the prevailing attitude of the industry. The letter conveys the belief that HRA has the support of the clinical trial industry. As such, while the court found it needs to make some changes to its website, the campaigners are keen for HRA to continue in the direction it was heading prior to the challenge.

"You will not need to change your objectives for research transparency, which will play a key role to safeguard patients, as well as build public confidence and greater involvement and participation in health research. We therefore urge you, as a small organization with limited resources, under no circumstances to let the distraction of the judicial review derail you from achieving these key objectives," the campaigners wrote in a letter to HRA Chief Executive Dr Janet Wisely.

EMIG Letter, Pharmafile

Other News:

EMA has confirmed it is working on an inventory of pediatric medicine needs focused specifically on newborns. The regulator made the statement after feedback to its draft list of paediatric needs noted the lack of sections on the pharmacodynamics, pharmacokinetics, efficacy and safety of insulin and hydrocortisone in newborns, particularly those born prematurely. Comments

An investigation by MHRA has led to the sentencing of a man for selling erectile dysfunction drugs illegally. The court sentenced the man to 16 months in prison for importing and supplying unlicensed medicines. MHRA seized medicines valued at £900,000 ($1.4 million) during the course of the probe. The drugs were imported from India for distribution across Europe. Press Release

MHRA has upheld a complaint about the promotion of homeopathic remedies by the websites of Nelsons Homeopathic Pharmacy. The regulator released little information about the case, but the complainant, The Nightingale Collaboration, has outlined why it felt action was necessary. The case involved the citing of indications for homeopathic products. MHRA Release, Nightingale Blog

The National Institute for Health and Care Excellence (NICE) has issued guidance to cut the use of antibiotics in the UK. NICE thinks its guidance could cut antibiotic prescribing by 25%, a drop that would amount to 10 million fewer scripts being written every year. The watchdog has tried to lower antibiotic use before with limited success. OnMedica