Cost-volume contract regulations take effect in Romania in Q1 2015

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In addition, the documents proving that a given person is insured within the national health insurance system have been replaced by national health cards, or an insurance certifi­cate valid for three months, for people who ex­plicitly refuse the receipt of the national health card for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.

[1] Article published in PMR Pharma & Healthcare Insight: Central Europe, Issue No. 10 (147), on 13.05.2015.