Joint working and the ABPI Code of Practice for the Pharmaceutical Industry
The ABPI has issued guidance notes on joint working between pharmaceutical companies and the NHS and others for the benefit of patients. The ABPI guidance refers to the Code but extends beyond it. [Link to ABPI guidance]
Joint working between the pharmaceutical industry and the NHS covers situations where, for the benefit of patients, the skills, experience and/or resources of the NHS and one or more pharmaceutical companies are pooled for the joint development and implementation of patient centred projects and a commitment to successful delivery is shared (the Department of Health definition of joint working in its ‘Best practice guidance on joint working between the NHS and the pharmaceutical industry’). In addition the ABPI guidance notes state that each party must make a significant contribution and the outcomes must be measured. Treatments must be in line with nationally accepted clinical guidance where such exists. Joint working between the pharmaceutical industry and the NHS must be conducted in an open and transparent manner. Joint working must be for the benefit of patients but it is expected that the arrangements will also benefit the NHS and the pharmaceutical company or companies involved. Joint working differs from the situation where pharmaceutical companies simply provide funds for a specific event or programme.
One of the concerns about joint working often raised by companies is the impact of the Code, particularly Clause 18 on joint working.
Clause 18.1 states:
‘No gift, benefit in kind or pecuniary advantage shall be offered or given to members of the health professions or to administrative staff as an inducement to prescribe, supply, administer, recommend, buy or sell any medicine’.
Inexpensive promotional aids relevant to the practice of their profession or employment may be given and these are covered by Clause 18.2.
Clause 18.1 deals with inducements given to individuals rather than to institutions such as hospitals or trusts etc.
Clause 18.5 states:
‘The provision of medical and educational goods and services in the form of donations, grants and benefits in kind to institutions, organisations or associations that are comprised of health professionals and/or that provide healthcare or conduct research (that are not otherwise covered by the Code) are only allowed if:
• they comply with Clause 18.4 or are made for the purpose of supporting research
• they are documented and kept on record by the company
• they do not constitute an inducement to prescribe, supply, administer, recommend, buy or sell any medicine.’
The supplementary information to Clause 18.5 states that donations and grants to individual health professionals are not covered by this clause.
Clause 18.5 relates to donations and grants etc and not to activities involving the sale of medicines.
It seems that Clause 18.5 would have no application to arrangements where goods and/or services are provided as part of an agreement between an institution and a company which involves the sale of medicines by the company to the institution.
Clause 18.6 states:
‘Contracts between companies and institutions, organisations or associations of health professionals under which such institutions, organisations or associations provide any type of services on behalf of companies (or any other type of funding by the company not otherwise covered by the Code) are only allowed if such services (or other funding):
• comply with Clause 18.4 or are provided for the purpose of supporting research
• do not constitute an inducement to prescribe, supply, administer, recommend, buy or sell any medicine.’
This clause would appear to have no application to activities involving the sale of medicines to institutions etc.
In conclusion, it seems that neither Clause 18.5 nor Clause 18.6 would impact upon joint working between the pharmaceutical industry and the NHS where this involved the sale of the participating company’s medicines. If the company’s medicines were not sold as part of the joint working, Clause 18.5 might apply.
Clause 18.4 permits the provision of medical and educational goods and services which enhance patient care or benefit the NHS and maintain patient care subject to the provisions of Clause 18.1 of the Code. They must not bear the name of any medicine. The provision of medical and educational goods and services does not meet the definition of joint working.
The supply of medicines
Various other arrangements may be entered into by pharmaceutical companies and it is necessary to distinguish between them when considering the application of the Code.
A straightforward sale is where the medicine is simply sold and there are no accompanying goods or services etc. Prices, margins and discounts which were in regular use by a significant proportion of the pharmaceutical industry on 1 January 1993 are excluded from the application of the Code (Clause 1.2). ‘Prices’, ‘margins’ and ‘discounts’ are primarily financial terms.
A package deal is where the purchaser of a particular medicine receives with it certain associated benefits, such as apparatus for administering the medicine or the services of a nurse to administer it. The transaction as a whole must be fair and reasonable and the associated benefits must be relevant to the medicine involved.
An outcome or risk sharing agreement is where a full or partial refund of the price paid for a medicine, or some other form of recompense, is due if the outcome of the use of the medicine in a patient fails to meet certain criteria. That is to say its therapeutic effect does not meet expectations. Clear criteria as to when a refund or other recompense would be due must be settled in advance and set out in the agreement. Any refund or recompense must always go to a health authority or trust and the like and never to individual health professionals or practices etc.
Section 3 of the ABPI guidance on joint working includes a list of activities/practices that are not within the definition of joint working.
Changes to the Code
The next version of the Code will include changes to take account of the ABPI guidance.
