By Sorin Strătulă
A number of important regulations of significance to pharmaceutical companies operating in Romania took effect in the first quarter of 2015. These refer, in particular, to cost-volume contracts to be signed with drug manufacturers and the evaluation and approval of the advertising of medicinal products for human use1.
Government Ordinance No. 11/2015 amending and supplementing Law No. 95/2006 on healthcare reform
In accordance with Art. 1 of the ordinance, which amends Art. 175 of Law No. 95/2006 on healthcare reform, sanitary authorisation is issued under the terms laid down by the rules approved by the Health Minister and entitles the hospital to function. After obtaining the sanitary authorisation, the hospital, upon request, begins the accreditation procedure. This procedure cannot be extended for more than five years.
Failure to obtain accreditation within five years of the issuance of the operating licence makes it impossible to conclude an agreement with the National Health Insurance House (CNAS) for the provision of reimbursed medical services.
The sanction which takes effect in the case of failure to obtain accreditation within five years has been changed. The initial form of the article provided that, in such a case, the hospital would be closed.
Accreditation of health units is granted by the National Authority for Quality Management in Healthcare, instead of the National Commission for Hospital Accreditation.
In addition, the documents proving that a given person is insured within the national health insurance system have been replaced by national health cards, or an insurance certificate valid for three months, for people who explicitly refuse the receipt of the national health card for religious or conscientious reasons.
Health Minister Order No. 03/01/2015 on a contract model, negotiation methodology and the conclusion and monitoring of the implementation of cost-volume/cost-volume-outcome contracts
Health Minister Order No. 03/01/2015, pertaining to the negotiating and conclusion of cost-volume contracts to be signed with drug manufacturers, was published in the Official Gazette of Romania, Part I, No. 29 of 14.01.2015.
In accordance with the earlier Government Emergency Ordinance (GEO) No. 77/2011, Art. 12 para. (2), regarding the establishment of contributions for the funding of some health system expenses, cost-volume/cost-volume-outcome contracts represent mechanisms designed to ensure financial sustainability and the predictability of costs in the health system, and they oblige authorisation holders of medicinal products who are Romanian legal persons and legal representatives of marketing authorisation holders (MAHs) of medicinal products which are not Romanian legal entities, to undertake to supply medicinal products on the international non-proprietary name list of drugs (the INN List), with the amount determined in accordance with this emergency ordinance, for a given category of patients and for a specific time period. (…). The contract model and the negotiation methodology, conclusion and monitoring of the implementation and cost of the cost-volume/cost-volume-outcome contracts is determined by Order of the Minister of Health and President of the CNAS.
In order to initiate the negotiation process, the MAHs/legal representatives described in Art. 1 para. (1) of the Order, must, within 30 working days of the date of the issuing of the decision on conditional addition to the INN List or of the date of the settlement of the complaints made by them against this decision, submit an application to the CNAS which expresses their availability to start the negotiating process.
The application will be accompanied by a decision issued by the National Agency for Medicines and Medical Devices which establishes the conditional addition of the drug to the INN List, and the proposal put forward by the MAHs/legal representatives described in Art. 1 para. (1) on matters referred to in Art. 12 para. (5) GEO No. 77/2011, as amended and supplemented, essential to the negotiation and conclusion of the cost-volume/ cost-volume-outcome contracts.
Health Minister Order No. 194/2015 on the authorisation of the Rules governing the evaluation and approval of the advertising of medicinal products for human use
These rules include all methods of promotion, namely those described in Art. 4 pt. 21, including the handing out of promotional materials by medical representatives, advertising in magazines, journals and scientific publications, direct mail advertising and other means of electronic communication (sites, websites, blogs, forums), along with the use of audio-visual products such as films, video and data storage services.
These rules apply not only to pharmaceutical companies themselves, and to subsidiaries and representatives, but also to any other partners with whom there is a contractual relationship intended to carry out medicinal product advertising of any kind.
Pharmaceutical companies and their representatives are responsible for compliance with the obligations established by these rules, even in cases of the transfer to third parties of promotional activities, advertising or implementation.
In accordance with these rules, the advertising of medicinal products:
– must be accurate, balanced, fair, objective and complete to enable those to whom it is addressed to form their own opinions on the therapeutic value of the medicinal product,
– must be based on an updated assessment of all relevant evidence and reflect that evidence clearly,
– must encourage the rational use of the drug by presenting it objectively, without exaggerating its properties,
– should not encourage self-medication and the irrational use of medicine,
– should not be misleading or subliminal, or mislead by distortion, exaggeration, undue emphasis, omission or in any other way,
– should not suggest that a drug or active ingredient has any merit, quality or property if this cannot be scientifically documented,
– should not prejudice respect for human dignity,
– should not include discrimination based on race, sex, language, origin, social origin, ethnic identity or nationality,
– must not prejudice the image, honour, dignity and privacy of individuals.
Advertising to the general public is forbidden for medicines which:
– do not have a valid marketing authorisation in Romania,
– are available only on prescription,
– contain substances defined as narcotics or psychotropic in accordance with the legal provisions in force,
– are prescribed and dispensed in the health insurance system, with the exception of vaccination campaigns carried out by the pharmaceutical industry and approved by the Health Ministry.
 Article published in PMR Pharma & Healthcare Insight: Central Europe, Issue No. 10 (147), on 13.05.2015.