The latest code of ethics for the Portuguese association of the pharmaceutical industry (APIFARMA) came into force in January 2014. The Code (which to give it its full title is also known as the Code of Ethics for Promotion Practices of the Pharmaceutical Industry and Interaction with Health Care Professionals and Institutions, Organizations and Associations Comprising Health Care Professionals) emphasises that “Ethical issues should be, and have been, throughout the years, a real concern for the Portuguese Pharmaceutical Industry.”
Currently, APIFARMA represents more than 120 companies across Portugal who are responsible for the production and marketing of medicinal products for human and veterinary use, vaccines, and in vitro diagnostics. APIFARMA’s main stakeholders come from public administration, parliamentary committees, national and international agencies, patient associations and institutions representing workers. The goal of the Association is to work with stakeholders to develop the social and economic side of the pharmaceutical industry and to improve health in Portugal through greater patient access to new therapies.
Since 1987, APIFARMA had been governed by its Code of Ethics, which has, over the years, incorporated changes at the national and EU level: for example, with influence from both the International Federation of Pharmaceutical Manufacturers (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) regulations. The goal of the Code, according to APIFARMA, is to provide the best medical services to the public by ensuring that medicinal products and in vitro diagnostics are chosen because of their merits and their ability to address patients’ clinical needs.
The Code therefore addresses transparency in the pharmaceutical industry, which is recognised to have an impact on ensuring that medicines and treatments are selected objectively according to their benefits to the patient. For example, there are strict rules governing sponsorships and grants to healthcare professionals and also the provision of gifts or other benefits. No gifts, prizes, bonuses, cash benefits or benefits in kind can be given, offered or promised to healthcare professionals, except for over the counter medical products and in vitro diagnostics, which can be given in low cash value (under €25) and must be relevant for the practice of medicine and/or a benefit to the patient.
According to the Code, pharmaceutical companies may supply educational materials to healthcare professionals, provided that they are of low cash value, relevant for the practice of their professional activity and bring direct benefits to the patient. However, gifts for healthcare professionals of a personal nature, such as tickets for entertainment events should not be given. Hospitality provided for promotional, scientific or education events should be linked to travel, meals, accommodation and registration costs and this should be at a reasonable level of remuneration, as detailed in the Code.
Disclosure is covered in detail in chapter 5 of the Code, where it states that the pharmaceutical industry must document and reveal to the general public any information on gifts, sponsorship or any other forms of direct or indirect payment to a healthcare professional, a healthcare institute or organisation. The disclosure of information should be made individually, identifying each recipient, which makes the Code fall into line with recent changes at the European level to the EFPIA code.
The Code also states that disclosure for all payments should be made annually and the information should be disseminated through an electronic platform for public access, a practice already carried out in several other European countries.