Medicament makers are forbidden from giving gifts to prescribers or sellers of drugs. The latter are forbidden from accepting the gifts.
Last weekend, twenty or so Estonian apothecaries attended a Vitabalans Pharma organised trip to London. State Agency for Medicines (SAM) is checking the legality of the event.
«Selling rights holder (manufacturer of medicinal products) is forbidden from granting to prescribers of medicines, dispensing chemists and pharmacists gifts or services, the value of which exceeds €6.40, except in the cases of support for participation at pharmacy related or medical science events organised by research institutions or a professional association,» explained Kaili Lellep, legal adviser to SAM.
Ms Lellep added that it didn’t make any difference if, in the drug maker’s opinion, the gift was not aimed at increasing the sales of a medicine. «Pursuant to Medicinal Products Act, holders of marketing authorisations are forbidden from giving gifts to prescribers of medicines, dispensing chemists and pharmacists, and the latter are forbidden from accepting such,» underlined Ms Lellep.
SAM is, at the moment, involved in providing explanations in misdemeanour procedure related to the facts and circumstances of the trip organised by Vitabalans Pharma OÜ, and cannot give its assessment as yet.
According to Ms Lellep, harmonised requirements apply to medicament advertisements all across the European Union, including such as relate to affecting sales of medicaments.
Pursuant to law, medicaments producers may support participation of pharmacists and doctors at pharmacy related or medical science events organised by research institutions or a professional associations, partially compensating participation fees of the scientific parts of the events, plus accommodation and transport costs up to a reasonable degree.
«Support granted may not relate to a specific medicament or the sales or prescription of a definite medicament; and it must be done based on a contract,» stressed the legal adviser. Of such benefits, SAM shall be informed by February 1st, regarding previous calendar year.
Last year, 27 precepts were issued by SAM regarding violations of medicament advertisement rules. 17 cases of these concerned failures to file the benefits information. In one instance, SAM ruled misdemeanour had occurred by affecting prescription and sales of a medicament by means of gifts.
Ship trip to Sweden and back
The ruling stated that a medicament sales right holder organised a 3-day Tallinn-Stockholm-Tallinn cruise for 352 dispensing chemists and pharmacists, including a one day tour in Stockholm. The voyage featured a 2-hour conference where the sales rights holder’s representatives made presentations and, among other things, published an advertisement of the medicament. The sales rights holder compensated the participants’ Tallinn-Stockholm-Tallinn cruise, catering on board and tours.
In 2011, SAM issued 47 precepts regarding violations of medicament advertisement rules, 25 of those for failure to file the report required.
One misdemeanour judgement was based on violation of drug ad rules and attempts to affect prescription and sales of a medicament by gifts.
The information published at a scientific event by the sales rights holder, regarding a medicament, violated medicament advertisement rules; the entertainment part of the event substantially exceeded its scientific section.
SAM, citing misdemeanour, ruled that organiser of the event pay a €25,000 fine. By court judgement, this was reduced to €15,000.