Over the past decade, Spain has been one of the leading countries in Europe to develop and improve the self-regulation and surveillance of its pharmaceutical companies.  Farmaindustria, the Spanish Association for the pharmaceutical industry in Spain, of which the great majority of pharmaceutical companies based in Spain are members, is responsible for overseeing the industry’s self-regulation system.

Farmaindustria: a history of surveillance

In 1991, Farmaindustria adopted the European Code of Good Practice for the Promotion of Medication, established by EFPIA, the European Federation for the Pharmaceutical Industry. The code was formulated to build confidence in the pharmaceutical industry and laid out a series of rules for good governance of the pharmaceutical industry, including rules for holding industry events and monitoring the relationship between such events and the doctors who prescribed pharmaceuticals that are discussed at the meetings.

The aims of the Association are linked to the fact that the State not only pays a large percentage of the cost of medicines dispensed in Spain, but also decides what medicines should be sold, how they should be made and dispensed and how much they should cost.

Ligne2The aims of Farmaindustria are:
•    To collaborate with Public Administration in establishing a regulated and economic framework that will favour a balanced market growth, an increase in R&D activities and to further the development of the pharmaceutical industry.
•    To strengthen public perception of the pharmaceutical industry and its medicines. To get the message across to citizens, opinion leaders and to persons who hold responsible posts the true value of medicines and their contribution to our social progress and to our quality of living.
•    To provide services to the member companies in areas of information, assessment and business collaboration.
•    To represent the pharmaceutical industry established in Spain, at both a national and international level.

The Unit for Supervising Ethical Practices and the Code of Practice

By 2004, as the Code became fully established in Spain, Farmaindustria then created its ‘Unit for Supervising Ethical Practices’, which is responsible for investigating and dealing with alleged acts of non-compliance and ethical violations by pharmaceutical companies. Today, the basis of the self-regulation system of the pharmaceutical industry in Spain is the 2010 ‘Code of Practice’, which has recently been updated to incorporate changes at the European level about disclosure of payments to healthcare professionals and organisations.

Article 10 of the Code limits the value of gifts that can be given to healthcare professionals making gifts over 10 Euros unacceptable except “ if they are medical items or technological materials, provided they are delivered to the health institution and not to the healthcare professional. These must be items for professional use in the practice of medicine or pharmacy that can be used for management of the physician’s clinical practice or his/her training within the institution, including material on digital support. All materials provided must be to benefit the patient and to improve the practice of medicine.

Article 11 deals with ‘Hospitality and Meetings’ and states that “Pharmaceutical companies may organize or collaborate in events of a purely scientific-professional nature. It is not permitted to organize or collaborate in events containing elements or activities of an entertainment or recreational nature…Hospitality at professional and scientific events should be reasonable at all times, and its cost cannot exceed what recipients would normally be prepared to pay for themselves in the same circumstances. Hospitality must always be secondary to the main purpose of the meeting. The scientific goals must represent the main focus in the organization of such meetings.

For hospitality and events, mandatory communication by the pharmaceutical company to Farmaindustria must occur 10 days in advance when the three following conditions concur: the event is organized – directly or indirectly – wholly or mainly, by the notifying company; it includes at least an overnight stay; and it involves the participation of at least 20 HCP´s having their activity in Spain.

An update to the Code last month means that as of 2016, all payments and interactions with healthcare professionals and organisations will need to be recorded and published on a public website: this includes all registration fees, transportation, hospitality, contracts (speakers, consultancy), grants, donations and contribution to events organised by third parties. Great news therefore, as, under the watchful eye of the Code of Practice Surveillance Unit, transparency in the Spanish pharmaceutical industry will continue to increase in the future in line with changes at the European level.

Ruth Knowles.