Medicines legislation consolidation and review project – Informal consultation on reducing regulatory burdens
Pharmacy leaders have urged the Medicines and Healthcare Products Regulatory Agency (MHRA) not to change the current arrangements regarding pharmacy wholesale dealing, which the Agency says have become “complicated.”
Section 10 of the Medicines Act exempts pharmacists in specific healthcare settings from some manufacturer and wholesale dealing provisions, but the number of amendments introduced over the years means these arrangements have become complicated, says the MHRA, in its recent “informal consultation” on streamlining and reducing regulatory burdens, conducted as part of its project to consolidate and review UK medicines legislation.
“We will generally review Section 10 to ensure that it is compatible with [EU legislation] and reflects current professional practice,” says the Agency in its consultation document.
But pharmacy leaders are urging the regulator to leave the arrangements as they are.
“Far from being complicated, the provisions are straightforward and have allowed community pharmacies to provide a service that benefits patients in the UK,” says a joint response submitted to the MHRA by Pharmacy Voice, the Pharmaceutical Services Negotiating Committee (PSNC) and Community Pharmacy Wales.
“It is in the interests of patients that community pharmacists continue to be permitted to carry out limited amounts of activities that some would describe as wholesale dealing. This includes selling medicines to other community pharmacies in the UK, or to healthcare professionals in the UK who require modest quantities of medicines to meet the needs of their patients,” say the pharmacist leaders.
“Pharmacies are also the source of medicines in limited quantities to those persons or groups of persons identified in the sale or supply exemptions. In practical terms, healthcare providers and those mentioned in the sale or supply exemptions require small quantities, and would not usually be in a position to open wholesaler accounts at reasonable costs to obtain these stocks,” they add.
While emphasizing that they do not support the export of medicines that are in short supply, the pharmacists state that they “do firmly believe that limited ‘wholesaling’ for use in the UK, to support patient care, is a vital role for pharmacies.”
As they stand, the Section 10 exemptions provide the right framework to ensure that patients receive the right medicine, at the right time, from a pharmacy premises that are convenient to access, the groups’ submission concludes.
“The existing provisions are straightforward and have allowed community pharmacies to provide a service that is in the best interests of patients,” said Rob Darracott, chief executive of Pharmacy Voice.
“Changing regulations around wholesale dealing will obstruct pharmacists in getting patients their medicines quickly and safely,” added Sue Sharpe, chief executive of the PSNC. “At a time where pharmacists are experiencing serious supply issues as a result of the indefensible supply problems with many important medicines, responsible professional-to-professional selling can inject much-needed flexibility into the local medicines supply chain,” she said.
The Royal Pharmaceutical Society has also strongly urged the Agency to retain the exception for pharmacists to hold a wholesale dealer’s licence. “The prospect of pharmacies routinely having to pay for and comply with the conditions of a wholesale dealing licence would be disproportionate to its safeguarding benefits, and would effectively increase the regulatory burden to pharmacies at a time when government policy intent is about right-touch regulation,” says the Society, in its response to the consultation.
