Apifarma

Code of Conduct governing the relations between pharmaceutical industry and patients' organizations

APIFARMA – Associação Portuguesa da Indústria Farmacêutica keeps a partnership with Portuguese Patients’ Organizations since the year 1999. At the same time it has been developing its work with European Patients’ Organizations in a close relation with EFPIA – European Federation of Pharmaceutical Industries and Associations.

Pharmaceutical Industry recognizes it has common objectives with Patients’ Organizations, which represent and/or provide support to the patients’ needs and/or the health care providers.

With a view to ensure the relations between the pharmaceutical industry and patients’ organizations are developed in an ethical and transparent manner, EFPIA approved, in October 2007, a Code of Conduct on the Relations between Pharmaceutical Industry and Patients’ Organizations.

This Code is based on the following principles, which have been updated by EFPIA and pan-European patients’ organizations, the last time in September 2006:

1. The independence of Patients’ Organizations regarding their political decisions, their policies themselves and their activities must be guaranteed.

2. All partnerships between Patients’ Organizations and the Pharmaceutical Industry should be based on mutual respect, each partner’s point of view being valued the same way.

3. Pharmaceutical industry should not request the promotion of prescription only medicinal products and Patients’ Organizations should not be engaged in those activities.

4. The objectives and scope of the partnerships should be transparent. The financial and non financial support provided by the Pharmaceutical Industry should be disclosed.

5. Diversified financing of Patients’ Organizations by multiple entities is welcome by Pharmaceutical Industry.

APIFARMA transfers this Code of Conduct to Portugal as to bind the relations between its member companies and any patients’ organization, irrespective of having or not having been incorporated as an organization.

The rules sanctioned here were freely discussed and voluntarily accepted, and are binding for all the member companies of APIFARMA.

1. This Code of Conduct aims at establishing a set of standards to govern the relations between the companies of Pharmaceutical Industry members of APIFARMA and Patients’ Organizations and/or Associations

2. The provisions of this Code are binding for all the member companies of APIFARMA.

b) “Patients’ Organizations” – the non-profit organizations comprising patients and/or health care providers, representing and/or providing support to the patients and health care providers’ needs and develop their activity in Portugal.

c) “relations between companies of Pharmaceutical Industry and Patients’ Organizations ” – any interaction among these entities, including the granting of funds by a company to a Patients’ Organization.

Under this Code, European and national legislation and regulations and the Code of Ethics of APIFARMA are applicable to Promotional Practices of Pharmaceutical Industry, namely as far as the prohibition of promotion of prescription only medicinal products among the general public is concerned.

1. Companies which want to provide direct or indirect financial support and significant non financial support to Patients’ Organizations should put it in writing, by means of an agreement signed by both parties, according to the form included in Appendix of this Code.

2. The agreement mentioned in the previous number should mention the express amount of the financing, as well as its purpose or a description of the significant non financial support as the case may be.

3. Each company should establish internal proceedings of formal approval of the agreements mentioned in the previous numbers.

1. The public use by a Company, in the scope of the agreements mentioned in the previous article, of a logo and/or materials subject to copyright belonging to a Patients’ Organization is subject to a written authorization given by the latter.

2. The authorization request mentioned in the previous number should clearly indicate the specific objective and the way the logo and/or materials subject to copyright are to be used by the company.

1. Companies should not try to influence the contents of materials produced by Patients’ Organizations they sponsor, so as to favour their commercial interests.

2. The obligation provided for in the previous number does not prevent companies to correct evidence-based and/or scientific inaccuracies existing in produced materials.

1. The list of Patients’ Organizations sponsored by each company in the scope of the agreements mentioned in article 3 should be disclosed, each year, with a short description of the nature of the provided support.[1]

2. Companies should make sure that the information on the sponsorship of Patients’ Organizations is disclosed in a clear and transparent manner.

No company can impose itself as to being the exclusive sponsor of a Patients’ Organization or of its main programs.

1. Any event organized or sponsored by a Company, or on its behalf, in the scope of the agreements provided for in article 3, should be carried out in a suitable venue according to the main purpose of the event.

2. Hospitality provided by Companies to Patients’ Organizations and their members should be of a reasonable level and be restricted to the main objective of the event, irrespective of being organized by the Patients’ Organization or the Company.

3. Provided hospitality should be restricted to travels, meals, accommodation and registration fees.

4. No Company should organize or sponsor an event outside its home country unless:

a) the majority of the guests/participants are foreigners and, taking into account the home countries of most of the guests it is more reasonable, in logistic terms, to carry out the event in another country; or

b) taking into account the location of the resources or relevant knowledge which are the object or topic of the event, it is more reasonable, in logistic terms, to carry out the event in another country.

1. 1. The implementation of the provisions of this Code should be supervised by the Council of Ethics of APIFARMA.

2. In the case a violation of the provisions of this Code is detected, the claim shall be sent to the Council of Ethics, following the steps in the proceedings provided for in the Regulation of the Council of Ethics.

3. The violation of the provisions of this Code by a company is considered as a disciplinary offence, and the applicable sanctions are provided for in APIFARMA Articles of Association.

4. The sanction applied, as well as the nature of the offence shall be published by APIFARMA.

Model of the written agreement between the Pharmaceutical Industry and Patients’ Organizations

This model comprises the essential aspects to include in a written agreement, under the provisions of Article 3.

· Names of organizations (pharmaceutical company, patients’ organizations and third parties called to cooperate, when applicable, as agreed between the pharmaceutical company and the patients’ organization);

· Type of activity (if the agreement has to do with subsidies non subject to conditions, meetings or specific publications, etc.);

· The role agreed to be played by the pharmaceutical company and the patients’ organization;

· Description of the indirect or significant non financial support (for instance, donation of time by public relations agencies, free training programs).

[1] This information should be disclosed for the first time by company members of EFPIA until the end of the first quarter of 2009 (including the activities which started or were in progress on 1 January 2008).

Code of Conduct in pdf