PRE-ASSESSMENT OF EVENTS WITH REGARD TO THE CODE OF ETHICS OF THE RESEARCH-BASED PHARMACEUTICAL INDUSTRY IN BULGARIA – ARTICLE 10 CODE PROVISIONS

ARPharM and its members are conscious of the importance of providing accurate, fair and objective information about medicinal products so that rational decisions can be made as to their use. The Code of Ethics of the Research-based Pharmaceutical Industry in Bulgaria fits into the general framework established by the EU Directive 2001/83/EC (Title VIII & Title VIIIa – p. 49 to 54), the Bulgarian Law on Medicinal Products and the EFPIA Code on the Promotion of prescription-only medicines to, and interactions with, Healthcare Professionals  which all lay down provisions on the information and advertising of medicines. The Code of Ethics of ARPharM seeks to ensure that pharmaceutical companies conduct such promotion and interactions with prescribers in a truthful manner, avoiding deceptive practices and potential conflicts of interest with healthcare professionals, and in compliance with applicable laws and regulations.

HCP (Healthcare professional) includes any member of the medical, dental, pharmacy or nursing professions or any other person who in the course of his/her professional activities may prescribe, purchase, supply or administer a medicinal product.

Any practice that might create confusion about the real scientific and educational purpose of scientific events sponsored by industry or to which industry sponsors HCPs should not be tolerated.

Article 10 of the Code of Ethics of ARPharM.

Through e4ethics ARPharM supports monitoring of third-party organised (a non-member company or organisation, which has not undertaken to comply with the Code), national events in Bulgaria, by pre-assessing events with regard to the ARPharM Code of Ethics. Companies belonging to the ARPharM membership are encouraged to consult e4ethics and should be mindful of the rules and provisions applying when deciding sponsoring, participating or collaborating in an event.

ARPharM will initially focus on major national events taking place in Bulgaria – i.e. events which are expected to attract more than 50 participants. Each event will be assessed with regard of common standards applicable, in particular with respect to provisions included in the ARPharM Code of Ethics Article 10.

THE PRE-ASSESSMENT WILL BE BASED ON THE FOLLOWING ASPECTS:

• Scientific Programme Schedule/Structure – the programme should show that the event has a genuine scientific purpose; the programme of the event posted on the Internet or provided through ARPharM membership  will be used for reference.
• Location and Venue – the venue must be conductive to the main purpose of the event (scientific / professional), avoiding venues that are renowned for their entertainment facilities or are extravagant as 5-star hotels in resort destinations.
• Hospitality Provided (Directly or Indirectly) to Healthcare Professionals – hospitality extended in connection with events shall be limited to travel, accommodation, genuine registration fees and meals, but cannot be extended beyond the official duration of the event; hospitality offered shall be reasonable in level and strictly limited to the main purpose of the event – as a general rule, the hospitality provided must not exceed what healthcare professional recipients would normally be prepared to pay for themselves.
• Other Activities – hospitality shall not include sponsoring or organising entertainment (e.g. sporting or leisure) events.
• Accompanying Persons – hospitality must not be extended beyond persons who qualify as participants in their own right.

The pre-assessment process involves an assessor’ team appointed by ARPharM’s Board. For further information please consult the observations index.

Conclusions of the pre-assessment posted on e4ethics, with the following colour-code for of each of the 5 areas (in contrast to a single composite assessment) covered by the ARPharM Article 10 Code of Ethics provisions:

• GREEN: based on information provided through one of the ways described above (on the date indicated), arrangements would not raise concern with regard to provisions of the ARPharM Article 9 Code of Ethics provisions. However, ARPharM members are invited to check application of laws, regulations and codes that may apply in Bulgaria.
• ORANGE: based on information provided through one of the ways described above (on the date indicated), arrangements may raise concern with regard to provisions of the ARPharM Article 9 Code of Ethics provisions. ARPharM members are asked to also check application of laws, regulations and codes that may apply in Bulgaria.
• BLUE: ARPharM’s pre-assessment process is ongoing. Meanwhile, please consult the observations index.

The pre-assessment of events provided on arpharm- e4ethics cannot, under any circumstance, be interpreted as a judgement on the quality or content of the scientific programme, or on the quality of the speakers.

It is the company’s individual decision to decide to sponsor / participate in the event. Companies belonging to the ARPharM membership should be mindful of the rules and provisions that apply when deciding to sponsor, participate or collaborate in an event.

EVENTS PRE-ASSESSED FOLLOWING THE ARPHARM PROCEDURE

For each event, general information (retrieved from public sources, in particular the events’ websites, other sources on the Internet or through ARPharM membership) includes:

• Name/title of the event
• Name of the organisers
• City/Place
• Starting date of the event
• Ending date of the event
• A link to the event’s website (when available)

To help locate information on a particular event, the database can be searched by the following classifications:

• by names of the events (alphabetically ordered)
• by names / acronym of the organiser of the events
• by medical speciality / (healthcare) area
• by dates of the events (from the nearest in time to the most distant)
• 15 last days (referring to events being updated in the last 15 days)

ARPharM can update the information included in arpharm-e4ethics at any moment. It is therefore recommended to consult the website regularly.

Any question, suggestion, commentary or clarification can be shared by e-mail at: info@arpharm-e4ethics.org

It is the company’s individual decision to decide to sponsor / participate in the event. Companies belonging to the ARPharM membership should be mindful of the rules and provisions that apply when deciding to sponsor, participate or collaborate in an event.