The UK’s Wessex Pharmaceutical Group has launched a new document aimed at reinforcing good practice on the sometimes slippery ground of relationships between the healthcare industry and patient associations.

The WPG, representing six companies in the south west of England that supply medicines and healthcare products to the National Health Service, also wants to address concerns raised in some quarters about the nature and purpose of working arrangements between industry and patient groups.

The document, Guiding Principles for Joint Working – Health Industry and Patient Groups, comes at a time when these links continue to attract hostile attention from the media. Moreover, in some cases they appear to be buckling under the strain of clarifying intentions through revisions to the UK industry’s code of practice.

Launched last week at the House of Commons, with cross-part MPs and representatives of the Wessex group companies (Astellas, Bayer, Genus, Nutricia, Shire and Valeant) and patient associations in attendance, the Guiding Principles draw on the experience of WPG member companies in developing good-practice policies for working with patient groups. They are designed to help both parties collaborate “in a manner which achieves the agreed objectives without compromising independence, patient choice, clinical judgment or probity."

The principles start from the assumption that joint working arrangements must be for the benefit of patients and carers, yet ultimately must meet the needs of both patient associations and industry. Within this framework, the document addresses a number of potentially sensitive issues, such as the need for transparency and compliance with professional or industry codes of ethics/practice and the relevant legislation; ensuring that joint working is not seen as an endorsement of any particular product or service; and clarifying the amount and nature of any support provided, whether financial or non-financial.

As an appendix to this document, the WPG has developed notes on practical considerations that companies and patient groups may want to raise and discuss when drawing up the certificated written agreements on joint working arrangements required under the ABPI’s updated Code of Practice. These deal with issues such as general terms and conditions, timelines for the proposed activity, governance and monitoring arrangements, and communications.

Patient associations becoming marketing tools?

The main spur to the WPG’s initiative was the sceptical view of relationships between industry and patient associations expressed in last year’s report on the influence of the pharmaceutical industry by the House of Commons Health Committee. The report cited evidence that “some groups receive substantial sums from industry and campaign to increase the availability of medicines for their members in the absence of strong supporting evidence”, as well as fears that pharmaceutical companies were using patient associations as surrogate marketing tools.

The health committee concluded that restricting or legislating against industry support for patient groups would disadvantage “both the charities that rely on industry funding and the industry itself, by cutting off a source of valuable feedback from the eventual consumers of its products”. But it did call for measures to limit the influence of industry on patient associations, such as obliging groups to declare all significant funding and gifts in kind.

The Association of the British Pharmaceutical Industry has tackled these concerns in the revised Code of Practice it implemented at the beginning of this year. A new clause (20.3) sets out a number of provisions for industry/patient group relationships, such as the need for a written agreement spelling out precisely the terms of the relationship and the amount of funding for every significant joint activity or ongoing relationship. All industry involvement must be declared and transparent. Companies have to publish, either in their annual report or on their website, a list of all patient groups to which they provide financial support.

Despite these efforts, and the pre-existing conditions or guidelines developed by the Charity Commission or groups such as the Long Term Medical Conditions Alliance, a residue of unease has clung to joint working arrangements. The obligation to make these relationships more transparent has not stemmed the bad press attaching to recent initiatives such as the Roche-funded Cancer United, a campaign pushing for equal access to cancer care across the EU.

Mixed feelings voiced over ABPI requirements

At the same time, both pharmaceutical companies and patient groups have voiced mixed feelings about the usefulness of the new ABPI requirements for joint working arrangements, particularly where these are seen to duplicate or overlap with existing provisions.

It is clear that Clause 20.3 – along with other facets of the revised Code – has demanded significant investment of time and resources from industry and its affiliates, to the extent that there are now worries about companies abandoning these relationships. Meanwhile, patient groups say the devolution of decision-making and budgets to local level under the NHS reforms has scotched any hope of government funding.

Ironically, one of the loudest complaints is about lack of clarity. While some patient representatives report an increase in offers of support from pharmaceutical companies since the updated Code came into effect, others regard its new provisions as heavy-handed and unnecessary.

Moreover, they claim these requirements are miring companies in legal interpretations and making them nervous about giving money to patient associations. One group says that, after 10 years of productive dealings with pharmaceutical companies, promises of support for next year have withered away because hiring lawyers to assure compliance with the Code is seen as too much trouble.

By Peter Mansell