Disclosure

Zambon Produtos Farmacêuticos, Lda. Methodology for Disclosure of Financial relations

Zambon - Produtos Farmacêuticos Lda. is the Portuguese based subsidiary of Zambon S.p.A. Headquartered in Italy. Zambon SpA is an Italian pharmaceutical company, associated with Farmindustria, the Italian pharmaceutical industry association Member of EFPIA (European Federation of Pharmaceutical Industries and Associations) .

Zambon Produtos Farmacêuticos Lda. is member of APIFARMA ( the Portuguese Pharmaceutical Industry Association).

Ethical issues should be, and have been, throughout the years a real concern for the Portuguese Pharmaceutical Industry. Since 1987 APIFARMA is governed by Codes of Ethics which, as time goes by, have undergone changes as a result of the changes of national and community legislation and the ongoing need to clarify concepts and practices.

Apart from the national and community legislation the various versions of Code of Ethics were also influenced by the Code of Ethics of IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) and EFPIA (European Federation of Pharmaceutical Industries and Associations) of which APIFARMA is a member, as well as the experience of the APIFARMA’s Council of Ethics.

The main goal of the Code of Ethics is to stand up for objective scientific information enabling a rational use of medicinal products marketed by the Pharmaceutical Industry companies associated with APIFARMA, creating an environment where the general public may be sure that the choices regarding their medicinal products are made based on the characteristics and benefits of each of them and the patients’ clinical needs.

This code also addresses a group of transparency rules aiming at disclosing the sponsorships and supports granted by the Pharmaceutical Industry companies to health care professionals and associations representing health care professionals and Patients, respectively.

The last version of the“Code of Ethics” (named “Code of ethics for promotion practices of the pharmaceutical industry and interaction with health care professionals and institutions, organizations or associations comprising health care professionals“) has been approved on 09/12/2013 and merges in a single body the previous version of the Code and the EFPIA Codes: “Code of Ethics on the Promotion of Prescription-only Medicines to, and Interactions with, Healthcare Professionals” and “Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations” approved in July 2013, integrating also the aspects regarding advertising of medicinal products according to Decree-Law no. 176/2006, of 30 August, as revised by Decree-Law no. 128/2013 of 5th September.

On the other hand, the relations of Pharmaceutical Industry with Patients Associations are governed by the “Code of Conduct for the relations between Pharmaceutical Industry and Patients Associations”, with similar goals

TRANSPARENCY AND DISCLOSURE

The national legislation (DL 176/2006, from 30th August 2006), the Code of Ethics and “Code of Conduct for the relations between Pharmaceutical Industry and Patients Associations” have special references, on Tranparency charpters, on disclosure of the information concerning transfer of values from Pharmaceutical companies to Heathcare Professionals, Health Care Organizations and Patient associations.

The most restrict of these documents is the national legislation (article 159º), where Pharmaceutical Industry companies marketing medicinal products have to document and disclosure to the general public any information on any directly or indirectly granted subsidies, gifts, supports, sponsorships or any other sum, asset or right with cash value, over € 60, to a health care professional or an institution, organization or association.

The disclosure of the information should be made individually, identifying the respective recipient on an electronic platform of public access maintained by the Healthcare Authorities, within 30 days after the transaction.

The public may consult the transparency register through the internet on https://placotrans.infarmed.pt/Publico/ListagemPublica.aspx

The data are searchable by the name of the recipient, i.e. the name of the healthcare professional, partnership or institution, by the pharmaceutical company name or by the activity. Entering the name will produce a list of the related reported financial relationships.

The register is searchable by year includes the following information:

  1. The name of the pharmaceutical company concerned;
  2. The name of the supported event/ action/kind
  3. The name of the healthcare professional, partnership or institution concerned;
  4. The amount;

The same legislation includes the obligation to healthcare professionals or institutions to report (in identical way) any directly or indirectly granted subsidies, gifts, supports, sponsorships or any other sum, asset or right with cash value, over € 60, received from pharmaceutical companies. This information is also available in the same interned site: https://placotrans.infarmed.pt/Publico/ListagemPublica.aspx

This public access is accepted by EFPIA in order to comply with the required disclosure information stated in “Code of Ethics on the Promotion of Prescription-only Medicines to, and Interactions with, Healthcare Professionals” and “Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations”, avoiding the need to add additional disclosure information.