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HDA UK Media And Political Bulletin – 12 January 2017

SecurMed UK is pleased to announce the appointment of Jerome Bertin as SecurMed UK General Manager from 01 January 2017. SecurMed UK is the UK Medicines Verification Organisation, a not-for-profit organisation which will deliver the UK Medicines Verification System.

Media Summary

Margins Bill costs tackled in the Lords 
Dispensing Doctor, Alisa Colquhoun, 12 January 2017

Former pharmacy minister Lord Hunt of Kings Heath has voiced concern at the cost burden for dispensers of the so-called ‘Big Brother margins’ Bill. In a heated debate at the House of Lords, Lord Hunt stated that the costs of implementing the Bill in the workplace – for dispensers, wholesalers and manufacturers – had not yet been quantified. Under-secretary of state for health Lord Prior of Brampton said that the Health Service Medical Supplies (Costs) Bill would “clarify and modernise provisions to control the cost of health service medicines and to ensure that necessary sales and purchase information can be appropriately collected and disclosed”.

Hunt denies community pharmacy funding cuts will deepen NHS crisis
The Pharmaceutical Journal, 11 January 2017

Health secretary Jeremy Hunt refuted speculation that the Government’s decision to cut the community pharmacy budget in England will worsen the NHS crisis. Hunt said that the pharmacy sector would have to endure its share of cuts in line with the drive for efficiency savings.
EU to adopt medical devices Regulations in May
Chemical Watch, Luke Buxton, 11 January 2017

The European Commission has announced plans to adopt Regulations on medical devices and in vitro diagnostic medical devices (IVDs) by the end of May. These moves have already been endorsed by the Council of Ministers’ Permanent Representatives Committee (Coreper) and the European Parliament’s Environment Committee (Envi). Within a year of the Regulation’s entering into force, the Commission will put forward mandates to regulate the preparation of guidelines.

 

Parliamentary Coverage

Pharmacies and Integrated Healthcare: England 
House of Commons, Debates, 11 January 2017

Mrs Anne Main (St Albans) (Con)

[…] We need to come up with a seamless, flexible model that makes the best use of precious resources and benefits patients. It is therefore timely to explore in this debate the role that local pharmacies play in local health services and the potential role that they might play to ease the strain on more congested frontline services. I also want to make the Government aware of the continuing importance of pharmacies in communities and their potential to do so much more.

In an ever-changing world, we have a duty continuously to challenge the old models of health delivery systems. In October, the Government proposed to reallocate money towards NHS frontline services. We all accept that the NHS is labouring under huge financial pressures, so any areas in which precious resources are dissipated due to inefficiencies or duplications ought to be considered. It is important to integrate community pharmacies into the NHS urgent care system and GP services. We need to promote a pharmacy-first culture for minor ailments to take pressure off frontline services.

Community pharmacies currently see some 1.6 million people a day in the UK. It is worth noting that the recent standard patient experience report for the East of England Ambulance Service NHS Trust in 2016 showed that 0% of respondents in my county of Hertfordshire had contacted a walk-in service, an out-of-hours GP service or a pharmacy service before contacting the ambulance service. I think we can agree that a lot more can be done to take the pressure off emergency frontline services […].

A full transcript can be found here.

Full Coverage

EU to adopt medical devices Regulations in May

Chemical Watch, Luke Buxton, 11 January 2017

The European Commission has said it expects to adopt Regulations on medical devices and on in vitro diagnostic medical devices (IVDs), by the end of May.

The Council of Ministers’ Permanent Representatives Committee (Coreper) and the European Parliament’s Environment Committee (Envi) endorsed the texts in June last year. They will replace existing Directives and their provisions will apply three years after publication for medical devices, and five years for IVDs.

The endorsed text for the medical devices Regulation includes a 0.1% concentration limit for category 1A and 1B carcinogenic, mutagenic and reprotoxic (CMR) substances and endocrine disrupting chemicals (EDCs) in devices

that:

  • are invasive and come into direct contact with the body; or
  • (re)administer, transport or store medicines, body liquids or other substances, including gases, to/from the body.

Devices would only be permitted to contain such substances at a level above this limit if a justification is provided.

Within a year of the Regulation’s entry into force, the Commission will provide a mandate for the relevant scientific committee to prepare guidelines on phthalates. This would include a benefit-risk assessment of their presence, as they are CMRs or EDCs. And such assessments would have to be updated within five years.

The Commission would also issue similar mandates for the preparation of guidelines on other CMRs.
The Regulations include labelling provisions. A label on the device and the packaging would have to say if the devices, their parts or materials contain a CMR or EDC above the concentration limit. And a list of such substances must be included.

The Commission released a timetable, at a steering committee meeting of the European database for medical devices (Eudamed), on 14 December.
The timetable is as follows:

  • 18-19 January: experts meet to approve final text in English after lawyer-linguists (LL) verification;
  • mid-February: completion of translation of other languages; text distributed;
  • 1 March: Coreper expected to endorse texts;
  • 6 or 7 March: Council expected to give endorsement;
  • 16 March: announcement in Council plenary; first reading position and transmission to Envi;
  • 20-21 March: announcement in Envi and vote;
  • 3-6 April: plenary vote and signature expected; and
  • May: entry into force.

The Regulations will be published in the Official Journal shortly after adoption and enter into force on the 20th day after this.

Hunt denies community pharmacy funding cuts will deepen NHS crisis
The Pharmaceutical Journal, 11 January 2017
Health secretary Jeremy Hunt has denied that the government’s decision to cut the community pharmacy budget in England will deepen the current NHS crisis.
During a debate on mental health and NHS performance in the House of Commons on 9 January 2017, Hunt told MPs that the pharmacy sector had to face its share of the cuts and contribute to efficiency savings.
He also argued that it “did not make sense” for the NHS to continue to subsidise pharmacies that were “[geographically] very close to other pharmacies”, stating that 40% of pharmacies were “clustered in groups of three or more”. “Our reforms are designed to ensure, however, that where there is only one local pharmacy that people can access, that pharmacy is protected,” he said.
Hunt was responding to a question by Michael Dugher, Labour MP for Barnsley East, who asked: “Given the evidence that one in five people who would usually see a pharmacist for medical advice say that they will make a GP appointment if their local pharmacist is closed… and with the risk that many of those people in desperation will turn up at the local hospital, [is] the government in danger of making an appalling crisis in the NHS even worse?”
Earlier in the debate, Philippa Whitford, Scottish National Party MP for Central Ayrshire, said 93.5% of patients at A&E departments in Scotland were seen within four hours during Christmas week compared with between 50% and 60% of patients in England.
“That difference is down to how it [the NHS] is organised,” she said. “It is the fragmentation and the lack of integration. There are things that can be done. We can use community pharmacies and GPs, and try to bring the NHS back together.”
Hunt admitted Scotland “has gone further than England in the use of community pharmacy, which is to be commended” but said that England has gone further than Scotland in its plans to “reform and increase investment” in general practice.

Margins Bill costs tackled in the Lords 
Dispensing Doctor, Alisa Colquhoun, 12 January 2017
Former pharmacy minister Lord Hunt of Kings Heath has raised the cost implications for dispensers of the so-called ‘Big Brother margins’ Bill in an hour-long debate in the House of Lords.
During its second reading, Lord Hunt told the Lords that the costs of implementing the Bill in the workplace, for dispensers,wholesalers and manufacturers had not yet been quantified.
Given that the Government has a policy in relation to reducing the regulatory burden on industry, he said: “It is very difficult to understand why the department has gone for such a broad-based power. I will certainly be interested in seeing … focus on the information that the Government can prove they actually need.”
Moving the debate to its second reading in the Lords, under-secretary of state for health Lord Prior of Brampton said that the Health Service Medical Supplies (Costs) Bill would “clarify and modernise provisions to control the cost of health service medicines and to ensure that necessary sales and purchase information can be appropriately collected and disclosed.”
This would allow Government to control the cost of excessively priced unbranded generic medicines and provide comprehensive and accurate data with which to reimburse dispensers, including GP dispensers. “Taken together, these measures will secure better value for money for the NHS from its spend on medicines,” he explained.
Former health secretary Lord Lansley told the Lords that the pharmacy sector has a history of “significantly exceeding” planned margin retention, because of a lack of good information.
“An important purpose of the Bill is to get the margin survey right and … to make the reimbursement price deliver the agreed gross margin as part of the global sum to pharmacies,” he said.

HDA UK Media And Political Bulletin – 12 January 2017

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