New Mdeon Code: what are the main changes?

Mdeon's new code of ethics

Ethical health platform Mdeon published a new code of ethics on 31 August 2018 (the Code). As compared to the previous code of ethics (last reviewed by Mdeon on 01 January 2017), the new Code provides for several new provisions that are likely to impact on pharmaceutical and medical devices’ compliance policies.

Below is some background information on the scope of the Code and our summary of the main changes:

Scope

The Code is mainly divided into two parts:

• Part I outlines Mdeon and the Federal Agency for Medicines and Health Products (FAMHP)’s interpretation of the anti-gift principles applicable to the Life Sciences industry active in Belgium (article 10 of the Medicines Act of 25 March 1964 (the Medicines Act)). It regulates the transfers of value, whether direct or indirect (without distinction between the two), whether financial or in kind, made by Belgian or foreign pharmaceutical companies or medical devices companies, to the beneficiaries identified in article 10, paragraph 1, of the Medicines Act, namely: healthcare professionals having their place of practice in Belgium (HCPs), healthcare organisations with a registered seat in Belgium (HCOs), wholesalers and brokers of medicinal products or medical devices active in Belgium. Its scope remains unchanged.

• Part II implements the provisions of the Sunshine Act. The definitions of beneficiaries and companies caught by the Sunshine Act are broader in scope than under Part I. Please see our analysis of the Belgian transparency regime (August 2017) and our checklist for compliance (April 2018) for further details.

The Code and its new provisions entered into force on 01 September 2018.

Ban on fellowships (of more than three weeks)

In the past, Mdeon was of the opinion that the sponsoring of HCPs for their participation in fellowship programmes (ie uninterrupted trainings of several weeks or months) was outside its jurisdiction. Mdeon considered that fellowships did not qualify as scientific events which can be lawfully sponsored by the Life Sciences industry under Belgian law (for example Mdeon’s annual report of 2007 and 2013). On that basis, Mdeon deemed visa requests for fellowships inadmissible (ie such requests were simply not assessed by the Visa Bureau). However, in the absence of an explicit ban on fellowships in the law or in the previous codes of ethics, the practice of sponsoring HCPs for several months of practical training and/or educational courses - in Belgium or abroad - was well spread.

The new Code now includes a clear interdiction to sponsor HCPs for their attendance at so-called "long-term" scientific events, ie scientific events lasting more than three weeks. The rationale is that training courses should, according to Mdeon, always be combined with the exercise of the HCP’s profession, hence the exercise of such profession (for example, general medicine, surgery, cardiology, pharmacy, dentistry, nursing) should not be interrupted for a long time.

The Code does not make a distinction between the direct sponsoring of HCPs and indirect sponsoring of HCPs through eg educational grants with HCOs. Both options appear to be covered by the ban on fellowships.

Under the Medicines Act, direct and indirect sponsorships of HCPs for their attendance at scientific events are allowed in the conditions laid down in article 10, paragraph 2. The three-week criterion outlined above arises out of Mdeon’s interpretation of the law - in accordance with the statutory powers conferred by Mdeon via royal decree and as enforced by the FAMHP.

Sunshine Act (transparency)

The previous version of the Mdeon code of ethics used to include transparency provisions based on industry codes of ethics (pharma.be / beMedTech / Medaxes (ex-FeBelGen)). Since the entry into force of the Sunshine Act on 01 January 2017, these provisions have become obsolete.

Some of the key points to consider are:

• Belgian, EU and non-EU companies are required to disclose their transfers of value on betransparent.be as soon as their transfer of value with HCPs, HCOs, patient associations or in the context of R&D, have a connection to Belgium (and are caught by the Sunshine Act). Specific requirements apply to non-EU companies.

• Advantages in kind are also caught by the Sunshine Act. Examples of advantages in kind include, for instance, theoretical training or product training organised and offered by a company to an HCP, even if no payment has been made, nor expenses reimbursed. It is essential to evaluate (ie form an idea of the value, in EUR, of) any advantage in kind provided to HCPs or HCOs to disclose such advantages on betransparent.be.

• Belgian law addresses both direct and indirect transfers of value. Payments made to HCOs for the attendance of HCPs at scientific events, or payments to HCOs for scientific services provided by HCPs with a transfer of funds or retribution from the HCO to the HCP, must be disclosed on betransparent.be in the name of the individual HCPs, who will be considered as the final beneficiaries.

• Informing HCPs (natural persons) that their personal data will be processed for the purpose of disclosure on betransparent.be is a legal requirement. The EU GDPR lists the mandatory points that information notices should include. Mandatory information should be provided as soon as the data (eg HCP name, surname, profession, INAMI/RIZIV number) are collected from the data subject; for instance, at the time at contract signing. If not possible, ex-post information can be achieved by sending information notices to HCPs via email or regular mail.

Procedures with the Visa Bureau

The procedure for visa requests remains the same, with limited new additions. The Code clarifies, for example, that (i) "train the trainer" sessions do not qualify, according to Mdeon, as scientific events having a connection with the medical or pharmaceutical sciences (this information can already be found in FAQ 5.1), (ii) for international events, the event venue should be coherent in view of the participants’ countries of origin, and (iii) in case of an extension of stay for personal reasons, companies should not sponsor only the outward or return journey (in that case, the company's contribution should be limited as a pro rata of the time spent to attend the scientific event).

On the other hand, the voluntary notification procedure (procédure de notification / meldprocedure) has been repealed. This procedure used to allow companies to notify Mdeon, on a voluntary basis, of (i) scientific events that do not require a Mdeon visa under the law and (ii) fees paid to HCPs in exchange for scientific services.

However, requests for advice (demandes d’avis/vragen om advies) remain possible without any changes.

Enforcement

Infringements to the principles laid down in article 10 of the Medicines Act can be sanctioned by a criminal fine between €1,600 and €120,000 and/or an imprisonment sentence between one month and one year (for individuals), and a criminal fine between €4,000 and €240,000 (for companies).

In case of a breach of the transparency requirements outlined above, an administrative fine between €1,600 and €120,000 can be applied both in relation to individuals and companies.