Principles of good practice in Primary Care Rebate Schemes published for CCGs and GPs
In response to a wave of queries about Primary Care Rebate Schemes (PCRS), NHS LPP has published a series of principles designed to help GPs and CCGs to maximise benefits and avoid potential pitfalls.
Jas Khambh, Pharmacy & Medicines Use and Procurement Lead for Primary Care at NHS LPP, explains that these schemes are contractual arrangements initiated by pharmaceutical companies, or third party companies, which offer financial rebates on particular branded medicines. “It was unclear to the London Primary Care Medicines Use and Procurement QIPP group (which NHS LPP hosts) if such schemes are permitted under current regulations and legislation. We were also concerned that a PCRS should offer genuine benefits to the NHS and patients, and not become an administrative burden.
“To help to manage these very real concerns, NHS LPP obtained legal advice. We are now satisfied that the schemes are not unlawful per se. However, they need to meet certain requirements to avoid falling foul not only of the Drug Tariff and the controls on pricing under the NHS Act 2006, but of a raft of other UK legislation including the Medicines Act, Human Medicines Regulations, the Bribery Act and EU laws.
“What is also clear is that a prescriber’s first responsibility is to act in a patient’s best interests. Financial considerations come second. Our advice is that participation in any PCRS should be agreed at a statutory organisational level, not agreed at GP practice level.
“Once agreed, a rebate scheme becomes a contractual agreement between the manufacturer and an NHS legal entity. We have produced good practice guidance for CCGs and PCTs on how to robustly scrutinise and implement any proposed scheme.”
The overarching principles align with those identified in Strategies to achieve cost-effective prescribing (DH, October 2010). These include ensuring that decisions to initiate treatment or change a patient’s treatment regime should be based on up-to-date best clinical evidence or guidance, and that health professionals should base their prescribing decisions on individual assessments of their patient’s clinical circumstances.
Practical considerations highlighted in the NHS LPP guidance include avoiding schemes which encourage the exclusive use of a particular drug, only accepting volume-based schemes if clinically appropriate, and ensuring that a formal written contract is in place including an exit strategy to allow flexibility to respond to significant new clinical evidence or changes in market conditions.
The principles are freely downloadable from the NHS LPP website. The full legal advice is available, on request, only to NHS organisations and is provided on the understanding that it is applicable to NHS LPP – individual CCGs and PCTs considering a scheme and requiring clarification of particular issues should seek their own legal advice.