· Development of best practice guidance on how supply difficulties should be dealt with by doctors, pharmacists, manufacturers and wholesalers.

The targeted inspections mean that manufacturers and wholesalers will risk losing their licences and face prosecution if they breach legal duties on supply of medicines. Pharmacists and doctors risk being called to account by their professional bodies for breaching their ethical obligation to put patients first.

Ministers met with a number of pharmaceutical supply chain stakeholders from across the UK - including the Association of the British Pharmaceutical Industry, the British Association of Pharmaceutical Wholesalers, the National Pharmacy Association, the Pharmaceutical Services Negotiating Committee and the Medicines and Healthcare products Regulatory Agency - to discuss the nature and scale of medicines supply problems and how the issues can be tackled collaboratively.

The issue of medicine shortages was raised publicly last year when some pharmacists and patients found it difficult to get hold of certain drugs, as a result of a number of unscrupulous traders exporting medicines meant for NHS patients to Europe for profit, because of the cheaper pound.

Health Minister Mike O’Brien said:

“We have reached agreement on a way to help NHS patients get the medicines they need. Manufacturers, wholesalers, pharmacy bodies, regulators and Government all agreed to work together to resolve the issue.

“The lower value of Sterling has resulted in some medicines destined for NHS patients being sold abroad for extra profit by a small number of unscrupulous speculators. Some pharmacists have had trouble getting hold of certain drugs because of this. For months, I have been seriously concerned about the potential impact of this on patients. It is unacceptable that some people have already had to wait longer than they should have to get their medication. Patients must come before profits.

“This new package of measures will help to ensure that NHS patients do not suffer and get the care they need when they need it.”

Richard Barker, Director General, Association of British Pharmaceutical Industry, said:

“Getting vital medicines to NHS patients is the job of all of us in the medicines supply chain and so we welcome the collaborative approach being taken by the Forum. We also strongly support the proposal to raise the standards to be applied to the licensing of wholesalers, to reinforce their mission to deliver medicines to meet the needs of UK patients, who should be at the centre of all of our activities.”

Sue Sharpe, CEO of the Pharmaceutical Services Negotiating Committee, said:

"Nothing is more important to community pharmacists than obtaining and dispensing the medicines patients need. A collaborative approach is crucial to addressing this issue, and we are pleased that all parts of the supply chain are committed to working collectively and constructively. The robust package of measures that has now been agreed, including supporting all parts of the supply-chain with best practice guidance, will be instrumental in addressing this continuing problem."

Notes to Editors

The full list of actions arising from the summit is as follows. Although there was broad agreement from the organisations represented at the summit, some organisations need to still formally ratify the agreement.

As organisations representing the supply chain, regulators and Government, we will continue to work collaboratively to ensure that patients get the medicines they need.

The MHRA will undertake a proactive, targeted programme of inspection.

Those who are breaching existing duties to supply medicines, will face the consequences. Manufacturers and wholesalers risk losing their licences and prosecution, pharmacists and doctors risk being called to account by their respective professional bodies. The MHRA commits to investigating any suspected breaches of the regulations and the RPSGB or PSNI to any suspected breaches of the Code of Ethics referred to them. Evidence of suspected breaches should be referred to the MHRA or RPSGB or PSNI as appropriate.

The Government will raise the standards required for wholesaler dealers’ licences. This will be taken forward through the current MHRA consultation on strengthening the supply chain that ends later this month.

Through the Supply Chain Group, we will together develop and maintain a list of products in short supply, so that no-one has the excuse that they were not aware of supply difficulties.

Through the Supply Chain Group, we will jointly prioritise the products on that list for further examination, with a view to finding possible means of mitigation and resolution.

We will jointly develop best practice guidance for dispensing doctors, pharmacy, wholesalers and manufacturers to help them better manage the difficulties they face. This will include quota arrangements, ensuring awareness of contingency arrangements and communication with patients.

We will explore with manufacturers and wholesalers how we might place them under a more explicit duty to ensure that sufficient stocks are available to meet the needs of patients.

We agree to explore establishment of buffer stocks to be held by certain wholesalers to give greater flexibility to the supply chain.

We agree to regularly assess and monitor the situation through exchange of information.

The Medicines Supply Summit was held at the Department of Health on Tuesday 2nd March and attended by the following organisations:

Dispensing Doctors’ Association, Pharmaceutical Services Negotiating Committee, National Pharmacy Association, Royal Pharmaceutical Society of Great Britain, Association of the British Pharmaceutical Industry, BMA’s GP Clinical and Prescribing Committee, , Community Pharmacy Scotland, Pharmaceutical Contractors’ Committee – Northern Ireland, Pharmaceutical Society of Northern Ireland, Pharmaceutical Adviser, Welsh Assembly Government, Chief Pharmacists, The Association of the British Pharmaceutical Industry, Cymru, Community Pharmacy, Wales, Ethical Medicines Industry Group, British Association of Pharmaceutical Wholesalers.

Wholesalers and manufacturers have a legal duty to ensure an appropriate and continued supply of medicines and pharmacists and are bound by a code of ethics to put patients ahead of profit. The Government issued new guidance in November 2009, developed with all parts of the medicines supply chain, to make clear these legal and ethical duties as well as the consequences of breaching them. NHS Chief Executive David Nicholson and Chief Pharmaceutical Officer Keith Ridge wrote to NHS hospitals in February 2010 reminding them that they should be not be trading in medicines as it jeopardises patients’ care.

For further information, please contact the Department of Health Press Office on: 020 7210 5221.

Contacts:

Department of Health
Phone: 020 7210 5221
NDS.DH@coi.gsi.gov.uk