Farmindustria, the Italian Pharmaceutical Industry Association, has recently published the 2008 edition of its “Code of Professional Conduct” (hereinafter, the “New Code”). The Code, compliance with which is compulsory for affiliated companies, represents the commitment of the industry not only to abide by specific laws in force but also “to operate on the basis of transparent standards of conduct that regulate the various circumstances in which corporate activities take place”.
The New Code does not substantially amend the previous Code with the exception of provisions concerning “relationships with patient associations” (Section 4.5 of the New Code). A few minor changes are also introduced in relation to “scholarships and scientific consultancy” and “clinical trials and drug-related studies” set out in Sections 4.1 and 4.3 respectively.
As to the industry’s “relationship with patient associations”, Farmindustria implements in Italy, without major changes the “EFPIA Code on relationships between the pharmaceutical industry and patient organisations” (hereinafter, the “EFPIA Code”) of 5 October 2007. In particular, the EFPIA Code, which is due to be implemented by all national pharmaceutical industry associations affiliated to EFPIA, sets out the standards which must apply (in a manner compatible with national laws and regulations and in a way that is no less rigorous than the provisions contained therein) to relationships between EFPIA member companies (and their subsidiaries/contracted third parties) and patient organisations which operate in Europe.
In particular, Section 4.5 provides that any form of economic support, whether direct or indirect, by the pharmaceutical company towards a patient association must comply with the following criteria:
- A specific and preliminary agreement aimed at regulating the amount of financing and the reasons for its disbursement must be reached. For this reason, each pharmaceutical company must develop a standard internal procedure for the approval of such agreements;
- The public utilisation by a pharmaceutical company of the logo or material owned by a patient association must be authorised in advance by the Association. In order to acquire such authorisation, the objectives for and the manner of using such logos and materials must be clearly defined;
- Any form of sponsorship by pharmaceutical companies vis à vis the patient associations must be transparent and without promotional objectives;
- No company can request to be the sole financier of a patient association;
- In all cases in which travel or other forms of hospitality are provided, the provisions set out under Subsection 3 of the Code on conferences and congresses shall apply (i.e. hospitality of modest value); and
- The pharmaceutical companies must include on their own website a list of those patient associations that are supported by them.
According to EFPIA strategy, a review of the Code itself, and subsequently all of its national implementations, will be initiated before the end of 2010.