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HDA UK Media And Political Bulletin – 6 March 2017

Media Summary

EMA, FDA form transatlantic pact on site inspections
Pharma Times, Selina McKee, 3 March 2017

Under a new deal, regulators in the EU and US will act interdependently to ensure sites comply with Good Manufacturing Practice (GMP) to optimise capacity and reduce duplication. This follows strong evidence that EU and US systems have comparable regulatory and procedural frameworks for human medicines inspections. The move is also said to reduce administrative burdens and costs facing pharmaceutical manufacturers.

CQC cracks down on internet health providers
P3 Pharmacy, 3 March 2017

The Care Quality Commission (CQC) is calling on the public to be careful when buying medicines online, in addition to their taking action to close websites without sufficient safety measures. Conceding that these websites offer convenience to patients, the CQC is cracking down on those which pose a risk to patient safety, such as where customers may not be appropriately assessed when buying medicines online. The CQC will now visit online providers, working closely in partnership with relevant regulators, to check that providers are following professional and prudential standards.

Drugmakers pose Brexit Britain withdrawal risk
Reuters, Neil Unmack, 3 March 2017

Despite the success of Britain’s life sciences sector, the complications posed by Brexit could see global companies move research and manufacturing to other countries. Years of austerity mean the health service is not a big market. Some clinical trials are already said to being shifted to other countries more likely to use the drugs. The government, which announces its annual budget on March 8, could buy more innovative high-priced drugs, and make procurement quicker. It could also give tax breaks to drug companies; yet Europe may be even less tolerant of aggressive tax practices after Brexit.

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EMA, FDA form transatlantic pact on site inspections
Pharma Times, Selina McKee, 3 March 2017

Regulators in the EU and the US have signed a transatlantic agreement to recognise inspections of manufacturing sites for human medicines carried out in their respective countries.

Under the new deal, regulators on both sides of the Atlantic will now rely on each other’s inspections in their own territories to ensure that sites operate in compliance with Good Manufacturing Practice (GMP), to optimise use of capacity and reduce duplication.

The agreement follows robust evidence that EU and US systems have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines.

The move will enable both EU authorities and the US Food and Drug Administration to hone their focus on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured, to ensure their quality, safety and efficacy.

Around forty percent of finished medicines marketed in the EU come from overseas and 80 percent of the manufacturers of APIs for medicines available in the EU are located outside the Union.

According to the European Commission: “The enhanced cooperation with US regulatory authorities will improve the EU’s ability to identify and address problems at factories before they become a public health risk. It will also reduce the administrative burdens and costs facing pharmaceutical manufacturers, including smaller producers”.

CQC cracks down on internet health providers
P3 Pharmacy, 3 March 2017

The Care Quality Commission is calling on the public to be careful when buying medicines on the internet.

The CQC’s inspections of some companies that provide online primary care have found significant concerns about patient safety. Although the commission acknowledges that well-run services can offer a convenient and effective form of treatment, inspectors have found services that were too quick to sell medicines without doing enough to check whether they were appropriate, meaning that patients could be at risk of harm.

In a joint statement, four regulatory bodies – CQC, General Medical Council, General Pharmaceutical Council, and the Medicines and Healthcare products Regulatory Agency – have reminded providers and healthcare professionals working for these services that they must provide safe and effective care, including following professional guidelines.

CQC has also published information on how it inspects and regulates providers of digital primary care, as well as advice for the public when considering using an online doctor.

Professor Steve Field, chief inspector of general practice at the CQC, said: “We know that these websites can present convenient ways for people to access advice, treatment and medication. However, some services may be putting patients at risk. We are particularly concerned that risks to patients may not always be appropriately assessed or managed when they buy medicines online.

“As with conventional GP surgeries, these online companies and pharmacies are required to provide safe, high-quality and compassionate care and must adhere to exactly the same standards. They must not cut corners.”

Professor Field said the growth in online technology presents a real opportunity to improve people’s access to medical advice and treatment and it is important that healthcare services continue to innovate.

“However, in some cases we have found websites which in effect allow people to select their own medication, including medicines restricted as prescription-only, with little or limited clinical oversight. Patients can go online, self-diagnose their condition, order their own medicine and obtain a prescription from the online doctor service, with minimal checks on who they say they are and whether the medication is safe or appropriate for them, often within a matter of seconds.

“We know there are often inadequate identity checks, no checks on patient history or suitability, no checks with patients’ GPs, and no follow-ups or monitoring,” he warned.

The CQC will now visit online providers, working closely in partnership with the relevant regulators, to check that providers are following the appropriate professional guidance. It will take action to cancel or suspend the registration of providers who are putting their patients at risk.

Duncan Rudkin, GPhC chief executive, said: “Patients and the public always have the right to expect safe and effective care, whether they are receiving this care face-to-face or online. The regulators involved all have different responsibilities, but by working closely together, we can help make sure that people are receiving safe and effective care at each stage of the process, from when they first visit an online primary care service to when they receive their medicines from a pharmacy.

“Where necessary, we are carrying out further inspections of the pharmacies linked to the online primary care services being inspected by the CQC, to assess whether they are meeting our standards and appropriately addressing the issues and risks linked with online prescribing and dispensing.”

Chair of RPS England, Sandra Gidley, said the Society is fully supportive of the action taken by CQC and other regulators to shut down online primary care services that offer scant regard for patient care and safety when supplying prescription medicines, in particular with regards to access to antibiotics.

“Unless and until the standards for remote prescribing by private providers reflect the standard of face-to-face consultations in the NHS that have been used to reduce unnecessary antibiotic prescribing, we cannot support services that increase the inappropriate use of antibiotics.

“Community pharmacies offer the opportunity for patients and the public to obtain health advice and we always advocate a face-to-face consultation with their local pharmacist.”

Drugmakers pose Brexit Britain withdrawal risk
Reuters, Neil Unmack, 3 March 2017

Drugmakers could lump Britain with a withdrawal problem. They aren’t publicly threatening to pull staff out of the UK, as the automotive and financial industries have done. But Britain’s looming exit from the European Union gives them renewed negotiating power – especially after Prime Minister Theresa May’s gushing endorsements of the industry.

Britain’s life sciences sector is a success story. It employs over 100,000 people, and generates 40 billion pounds of sales – and is at the heart of a fuzzy industrial strategy outlined by the Conservative government on Jan. 23. Yet apart from locally listed companies like GSK and AstraZeneca, there’s nothing inherently British about it: global companies can move research and manufacturing easily to other countries.

That might happen. Years of austerity mean the health service is not a big market to sell to. Britain invests less in healthcare than counties like Denmark or Belgium, according to the Organisation for Economic Co-operation and Development. Some clinical trials are already being shifted to other countries more likely to use the drugs, according to one pharmaceutical company executive.

Brexit makes things worse in several ways. Border controls could deprive hospitals of staff, and laboratories of scientists. If Britain can’t persuade Europe’s regulator, the European Medicines Agency, to see it as equivalent, pharma groups might have to undergo a separate process to get drugs licensed – and such a small market would be far down the list of priorities.

The government, which announces its annual budget on March 8, can throw money at the problem. It could buy more innovative high-priced drugs, and make procurement quicker. It could simply give tax breaks to drug companies. Yet Europe may be even less tolerant of aggressive tax practices when the UK has left: it recently clamped down on the so-called “patent box” introduced by the last government.

Paying for drugs is less politically toxic than helping bankers. But in any case, Theresa May could have little choice if they decide to exploit their advantageous position. One of her first moves as leader was to complain that AstraZeneca was almost bought by U.S. group Pfizer, threatening – in words that may come back to haunt her – to defend an “important” sector. She cannot easily go cold turkey.

HDA UK Media And Political Bulletin – 6 March 2017

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