The concept of Beneficiary Entities for purposes of the legal framework applicable to the advertising of drugs and medical devices

On February 5 of this year, Decree-Law No. 5/2017, of January 6, entered into force, which approved the general principles of advertising of medicines and medical devices, and in this framework amended Decree- Law no. 176/2006 of August 30, which establishes the legal framework for medicinal products for human use, as well as Decree-Law no. 145/2009, of June 17, which establishes the legal framework of medical devices and accessories.

This law introduced new rules aimed at safeguarding transparency in the advertising of medicinal products and medical devices or in connection with their promotion, and in this way, to stimulate or revive the debate on the matter.

In terms of transparency and advertising, the legal frameworks approved by Decree-Law no. 176/2006 and Decree-Law no. 145/2009 contain almost identical rules, respectively in article 159 and in article 52, setting obligations, on the one hand, to entities covered by this Decree-Law (entities that investigate, market, manufacture or place on the market medicinal products for human use and medical devices), and on the other hand, to entities which obtain any benefits from the previous – the Beneficiary Entities. One of the most recurring doubts on this topic has been exactly which entities are considered beneficiaries for this purpose. Let’s see.

Under paragraph 5 of either Decree-Law no. 176/2006 or Decree-Law no. 145/2009, “Any entity covered by this Decree-Law , that directly or through an individual or collective person, grants or delivers any benefit to any entity, individual or a group, of any kind, nature or form, including health professionals or any other employee of the National Health Service or of bodies and services of the Ministry of Health [Decree-Law no. 145/2009 adds, “in cases legally admissible”], association, representative or otherwise, of patients, or a company, association or medical society of scientific nature or Of clinical studies, as well as establishments and services of the National Health Service, regardless of their legal nature and services and bodies of the Ministry of Health [Decree-Law No. 176/2006 adds “in cases admissible by law “], is subject to communicate it within 30 days from the date of the grant of benefit, in the appropriate place of the web page of INFARMED, I. P. “. Being the appropriate place the Communications Platform – Transparency and Publicity of INFARMED, I.P ..

Decree-Law no. 5/2017 ended the duplication of communications previously necessary, requiring only from the Beneficiary Entities the validation of the communication previously made by the medicines and medical devices companies or the communication of the reason for its non-validation to INFARMED, IP, as well as a reference to the fact in all the documents intended for public disclosure, that it issues in the scope of its activity. Beneficiary Entities are also required to register the granted benefits in the same Platform if they are directly or indirectly granted to health professionals (see article 11 of Decree-Law no. 176/2006 and article 10 of Decree-Law no. 145/2009).

In a first glance at the diploma, it seems to consider as a Beneficiary Entity:

  1. Any entity, a natural or legal person, of any type, nature or form, including:
    1. Health professional or any other worker of the NHS or of bodies and services of the Ministry of Health;
    2. Association, representative or otherwise, of patients;
  • Company, association or medical society of a scientific nature or of clinical studies;
  1. Establishments and services of the National Health Service, regardless of their legal nature;
  2. Services and bodies of the Ministry of Health.
  1. Which receives a benefit, which, within the meaning of paragraph 11 of those provisions, means “any advantage, value, good or right to be evaluated in cash, irrespective of the form in which it is awarded, whether as a prize, sponsorship, subsidy, fees, grant or other “.

Notwithstanding the apparent reach of a literal interpretation of those provisions, their scope should be restricted in view of the scope of the framework under consideration. Thus, it is not any and all entities that receive assets from a company of medicines for human use and medical devices, which must be included in the Transparency Platform of INFARMED, IP. If this were the case, any supplier of goods or service provider of one of those entities would be covered, which doesn’t seem appropriate in view of the purposes of the legislation in question. It doesn’t seem reasonable, for example, that the company providing cleaning services at the headquarters of a pharmaceutical company, or a law firm that advises or a distributor of x-ray equipment, is included here. The concept of benefit must be understood as an asset allocation made without an effective and equivalent compensation, that is, without a consideration of equal value.

The concept of the beneficiary must still be established through a systematic interpretation. The scope of these rules should be linked to the legal framework applicable to the advertising of medicinal products for human use and medical devices. As stated above, the purpose of Article 159 Decree-Law no. 176/2006 and Article 52 of Decree-Law no. 145/2009 is to ensure greater transparency in the advertising activities of Medicinal products and medical devices or related to their promotion, from which it follows that a benefit of a company covered by those diplomas only deserves public scrutiny when it is not awarded as a direct and effective consideration for the supply of a good or a service or if that good or service is included in an activity of advertising or promotion of medicines or medical devices, within the meaning of article 150 Decree-Law no. 176/2006 and article 43 of Decree-Law no. 145/2009, that is, information, prospecting or incentive that has as its object or effect the promotion of its prescription, dispensation, sale, purchase or consumption. Thus, payment for cleaning services at the head office of a pharmaceutical company or legal advice to a retailer of x-ray equipment is not subject to the obligation to communicate, in so far as it is paid in return for the services provided, which are not related to advertising or promotion activity.

In summary, the obligation to communicate to the Communications Platform – Publicity and Transparency of INFARMED, IP, and corresponding validation, only occurs when there is a grant of a benefit to any entity by a company of medicinal products for human use or medical devices, without any effective or equivalent consideration or, if existing, is included in an advertisement or promotional activity for a medicinal product for human use or medical device.

More in Communication