News

HDA UK MEDIA AND POLITICAL BULLETIN – 14 August 2017

MEDIA SUMMARY 

PSNC tells contractors to ‘exert maximum pressure on wholesalers’ to drive down price of pregabalin
The Pharmaceutical Journal, Ingrid Torjesen, 14 August 2017

The Pharmaceutical Services Negotiating Committee (PSNC) has told contractors in the NHS to “exert maximum pressure on wholesalers” to drive down the price of pregabalin. This comes after the drug was moved onto Category M on August 1st. Director of Pharmacy Funding for the PSNC, Mike Dent, said that pregabalin met all the criteria for M after the patent expired in July. This means that pharmacies will get reduced funding to buy the drug, but wholesaler prices have not caught up. Dent said “when the Category M reimbursement price for a particular product is reduced, it may take time, and sustained pressure from pharmacies, for wholesale prices to respond.”

GPhC signs joint statement on conflict of interest guidelines
P3 Pharmacy, 11 August 2017

The Royal Pharmaceutical Society has welcomed a recent statement from the General Pharmaceutical Council that outlines more clearly policies concerning conflicts of interest. The RPS agreed that those in the healthcare industry should “refuse all but the most trivial gifts, favours or hospitality”. The statement also includes the following recommendations:

  • Put the interests of people in their care before their own interests or those of any colleague or organisation
  • Consider where potential conflicts of interest may arise and be open about them
  • Be open about, and declare, any conflicts of interest they face
  • Reflect on their own learning and CPD needs regarding conflicts of interest
  • Ensure patients have access to visible information on any fees or charging policies for which they are responsible

The General Pharmaceutical Council said that “as health and care regulators, we share a commitment to collaborating on issues that affect patient safety and care…we are underlining the consistent expectations of health professionals in managing conflicts of interest”.

MHRA and Making a Success of Brexit
MHRA, 14 August 2017

The MHRA has released a summary press release covering recent Brexit developments, saying that it is “working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK”. It notes that while negotiations continue, the UK remains a “full member of the EU”. It also notes that is will seek to “maintain a close working partnership” with the EU. The MHRA plans to “continue to cooperate with all involved”.

PARLIAMENTARY COVERAGE

There is no parliamentary coverage.

FULL COVERAGE 

PSNC tells contractors to ‘exert maximum pressure on wholesalers’ to drive down price of pregabalin
The Pharmaceutical Journal, Ingrid Torjesen, 14 August 2017

Contractors struggling to source pregabalin at list price since restrictions placed by NHS England limiting the use of generic pregabalin were lifted have been told by the Pharmaceutical Services Negotiating Committee (PSNC) to “exert maximum pressure on wholesalers” to drive down its price.

In a letter to community pharmacies dated 21 June 2017, NHS England said previous dispensing guidance on pregabalin, which instructed pharmacists to return all prescriptions for generic pregablin for pain to the prescriber, was being withdrawn.

It informed pharmacists that from 17 July 2017 “when dispensing pregabalin for the treatment of any condition, you should dispense in accordance with your normal practice”.

Mike Dent, director of pharmacy funding at PSNC said pregabalin met all the criteria for inclusion in Category M (where the Department of Health calculates the reimbursement price of readily available generic drugs based on information submitted by manufacturers), so it was moved from 1 August 2017, following the patent expiry on 17 July 2017.

But some contractors claim they are now being forced by wholesalers to pay several times more than the drug tariff price for each pack of pregabalin.

Dent said: “The DH sets Category M prices at levels above the prices notified by manufacturers,” he explained. “But when the Category M reimbursement price for a particular product is reduced, it may take time, and sustained pressure from pharmacies, for wholesale prices to respond.

“During this period, it is essential that contractors exert maximum pressure on wholesalers. There have been a number of examples where manufacturers’ prices were below the Drug Tariff price but a product could not be obtained at the Drug Tariff price from a number of wholesalers.”

“We are aware that sometimes Category M medicines are difficult to obtain at the reimbursement set in the Drug Tariff and apply for price concessions as needed.”

The issue arose after a long-running patent dispute by Pfizer against generic drug manufacturers Actavis and Mylan over its product Lyrica. NHS England issued guidance on 2 March 2015 stating that any prescription for generic pregabalin for pain should be returned to the prescriber.

Pfizer developed Lyrica for the treatment of generalised anxiety disorder (GAD) and epilepsy but the patent for this indication expired in 2013. When Pfizer discovered that pregabalin could relieve pain, it took out a second medical use patent for Lyrica to cover this use, which expired in July 2017. When the first patent expired, Actavis and Mylan launched generic versions of the drug to treat GAD and epilepsy and the long-running court battle ensued.

GPhC signs joint statement on conflict of interest guidelines
P3 Pharmacy, 11 August 2017

The comment from the RPS came as the General Pharmaceutical Council joined other healthcare regulators in signing a statement setting out how conflicts of interest should be avoided, declared and managed across all healthcare settings.

Among the expectations outlined, the joint statement says healthcare professionals should “refuse all but the most trivial gifts, favours or hospitality” if accepting them could be seen as an attempt to gain preferential treatment or could go against their professional code of practice.

The statement also includes the following expectations of healthcare professionals:

  • Put the interests of people in their care before their own interests or those of any colleague or organisation
  • Consider where potential conflicts of interest may arise and be open about them
  • Be open about, and declare, any conflicts of interest they face
  • Reflect on their own learning and CPD needs regarding conflicts of interest
  • Ensure patients have access to visible information on any fees or charging policies for which they are responsible.

Case studies

The regulators have also published case studies to illustrate these principles. GPhC worked with the General

Medical Council and the Pharmaceutical Society of Northern Ireland to produce a case study scenario involving a private practice GP whose employer has told her to encourage patients to take their prescriptions to a pharmacy it has bought recently. This could also apply to a range of healthcare professionals who may have a direct or indirect financial interest in another business, GPhC says.

GPhC chief executive Duncan Rudkin said: “As health and care regulators, we share a commitment to collaborating on issues that affect patient safety and care, and the trust they place in the professionals who provide that care. By working closely with our fellow regulators, we are underlining the consistent expectations of health professionals in managing conflicts of interest, to help give patients and the public the assurance that their interests will always be put above any other interest a health professional may have.

“The joint statement supports the principles and guidance outlined in our standards for pharmacy professionals, and I hope the statement and case studies will provide helpful insight for our registrants when facing potential conflicts of interest.”

‘If in doubt, find out’

When contacted by P3, the Royal Pharmaceutical Society offered this advice for pharmacists: “There are well known concerns about actual and potential conflicts of interest across the NHS. If you are ever in doubt about whether you should declare a conflict or how to do it, find out. Transparency and openness will enhance the reputation of pharmacy and pharmacists and assure professional integrity and public confidence, while enabling collaborative working and constructive dialogue with suppliers of goods and services to the NHS.”

A professional guide on identifying and appropriately making declarations of interest is available to RPS members.

MHRA and Making a Success of Brexit
MHRA, 14 August 2017

Following the outcome of the EU referendum, the Medicines and Healthcare products Regulatory Agency (MHRA) is working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK.

While negotiations continue, the UK remains a full and active member of the EU, with all the rights and obligations of EU membership firmly in place. Working with our partners, stakeholders and customers, our focus remains: protecting health and improving lives.

Playing a full, active role in European regulatory procedures for medicines remains a priority. We contribute significantly in both the centralised and decentralised regulatory procedures, including new rapporteur and reference member state (RMS) appointments, and maintain our programmes for implementing EU legislation as required by our obligations as a Member State. We are also fully engaged in European and national scientific advice services and in delivering our EU inspection-related duties.

Our role in regulating medical devices and in vitro diagnostic (IVD) devices remains integral. We oversee the essential work of the five UK Notified Bodies; together they are responsible for assessing the majority of devices currently placed on the EU market. Our preparations to implement proposed new Regulations for Medical Devices and IVDs continue.

We maintain our role in vigilance, market surveillance and taking direct action, where needed, to protect patients and public health, and we continue to co-ordinate with other Competent Authorities, across Europe and internationally, in these and other areas.

Statements are also available from the British Pharmacopoeia and the National Institute for Biological Standards and Controls (NIBSC)

On 4 July the UK Government gave a clear, public statement of its desire to retain a close working partnership in respect of medicines regulation after the UK leaves the EU, in the interests of public health and safety. The statement, published in the Financial Times, by the Secretary of State for Health and Secretary of State for Business, Energy and Industrial Strategy laid out the three principles which will underpin the development of a post-Brexit regulatory system for medicines and devices: patients should not be disadvantaged; innovators should be able to access the UK market as quickly and simply as possible; and we will continue to play a leading role in both Europe and the world in promoting public health.

These principles and the government’s position were developed further in a speech by the Parliamentary Under Secretary of State at the Department of Health, Lord O’Shaughnessy, at the BIA/MHRA conference in London on 14 July.

We are aware of the recent notices to Marketing Authorisation Holders issued by the EMA/EU-27 and CMDh advising of preparations MA holders may want to consider ahead of the UK’s exit from the EU.

Until the exit negotiations are concluded, the UK remains a full member of the EU and all the rights and obligations of EU membership remain in force. We therefore continue to play a full role in the network and to undertake our work as a Reference Member State (RMS) in the decentralised procedure, and as (co-) rapporteur in the centralised procedure. If, however you do want to consider preparation for any potential changes to marketing authorisation or RMS, please see the information provided by the EMA and the HMA.

Whatever the outcome of the negotiation we will continue to collaborate with all involved to deliver the current speed of authorisations, access to new and innovative medicines and devices and to continue to ensure the quality, safety and efficacy of all medicines and devices, to safeguard an uninterrupted level of public health protection.

HDA UK MEDIA AND POLITICAL BULLETIN – 14 August 2017

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

Apply to become a Member

Membership of the HDA guarantees your organisation:

  • Access to leading policy and industry forums of debate and discussion
  • Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
  • Representation on HDA working parties, including the Members’ Liaison Group
  • A daily Political and Media Bulletin and HDA Newsletters
  • Access to HDA policy documents and all sections of the HDA website
  • Branding and marketing opportunities
Apply Now

Already a Member?