The issue of medicines shortages in the UK has been thrust firmly back into the spotlight with the publication of a ministerial report calling for urgent action to curtail the export of medicines for profit.
A six-month inquiry by the All Party Pharmacy Group into medicines shortages in the country has concluded that patients are still being put at risk by the excessive sale of medicines abroad by parallel exporters cashing in on the weak pound and the UK’s low drug prices.
Back in 2010 it was estimated that around £40-million worth of medicines – including some for potentially life-threatening conditions – destined for the National Health Service were being diverted abroad every month, despite a package of measures designed to curb such activity, which has been affecting the UK for four years.
This exporting is conducted by speculators and is legal under EU and UK law, and ministers say they have no problem with the principle of parallel exports as long as patients are not being harmed.
“However, throughout this inquiry we have seen evidence that patients are suffering and that pharmacists’ time and resources is being diverted away from patient care as a result of medicines being in short supply,” the APPG notes.
While the Department of Health has sought to address the problem, with measures such as setting and updating obligations under which supply chain participants must act and clarification of legal requirements, for example, “none of these steps has proved effective in mitigating the problem”, and 30-40 different medicines are still on the endangered list.
The APPG is calling for “a renewed sense of urgency” and tougher action to address the situation. European law allows the free movement of goods across its borders, but there is scope to exempt certain goods if public health is threatened, it says, stressing that the government “needs to consider the use of this exemption in the best interests of UK patients”.
In addition, the Medicines and Healthcare products Regulatory Agency must get better at enforcing obligations to protect patients on those with licenses to conduct wholesale activities, and must “consider carefully whether it is in the best interests of patients to see further growth in the number of wholesale dealer licenses”, it said.
The Royal Pharmaceutical Society (RPS) has backed the APPG’s calls for changes to EU law that “will put public protection before profit in medicines supply”.
New laws are now needed in the UK to ensure patients come first, said RPS England Board Chair and spokesperson Lindsey Gilpin, adding that Society will press the government “to introduce an exemption to European Law that means medicines are no longer freely traded across Europe when this threatens the health of patients”.
Martin Sawer, chief executive of the British Association of Pharmaceutical Wholesalers, stressed that the government must respond to the APPG’s recommendations “to ensure that patients have constant access to these life-saving medicines”.
“These recommendations can only be effective if enforced, and so we are calling on the Department of Health and the MHRA to show greater leadership to improve this unacceptable situation, which has gone on for too long,” he added.
Elsewhere, Sue Sharpe, Chief Executive of Pharmaceutical Services Negotiating Committee, said the DH must now look to solving the problem “through measures such as greater flexibility on quota arrangements, standardisation of emergency supply arrangements and locally managed buffer stocks, which will help to better translate the principles outlined in the joint best practice guidance”.
The ABPI said it was pleased “the need for action has been recognised”, but says the APPG’s recommendations don’t go far enough.
“Without the legal separation of pharmacy wholesaling and dispensing activities, industry is unable to prioritise pharmacists whose primary concern is UK patients, over those who are selling medicines abroad for a profit and causing the problems in the supply chain,” said chief executive Stephen Whitehead.