Proposed requirement for disclosure of marketing agreements causes surprise among intl pharma community – Sanofi
The Ministry of Health proposed requirement for full disclosure of the content of marketing agreements with pharmacies causes surprise among the international pharmaceutical community, Sanofi's public relations manager in Ukraine Natalia Baranovska said.
"Such a point of the new procedure [proposed by the Ministry of Health], as full disclosure of marketing agreements, caused considerable surprise among the international pharmaceutical community. We specifically analyzed the compliance of the proposed norms with European practice, in particular, in France, and did not find similar requirements for the mandatory disclosure of detailed commercial information, including for manufacturers of OTC medicines," she told Interfax-Ukraine, commenting on the Ministry of Health proposals for regulating marketing in the pharmaceutical market.
Baranovska said that "in fact, the market's pharmaceutical operators are obliged to submit detailed information about each concluded marketing agreement and promotion services to the State Health Service with its subsequent publication to the general public."
"Such a practice is not typical for EU countries, and the information itself has signs of commercial sensitivity that is not subject to open disclosure," she said.
The expert said that as of June 5, the final text of the proposed rules for marketing medicines by the Ministry of Health has not been published, however, "there have been repeated discussions."
She also said Sanofi operates in the prescription segment, in which "the issue of limiting marketing payments in percentage terms is generally not relevant."
"We do not order any marketing activities and services for the promotion of medicines, other services related to the sale of medicines to the end consumer in places of retail trade in medicines, that is, in pharmacies," she said.
In addition, Baranovska said that a complete ban on marketing in the retail pharmaceutical market has been in effect since March.
"We have had three months of complete lack of marketing activity in pharmacies. Therefore, before implementing new approaches, it is advisable to analyze the cause-and-effect relationships and economic consequences of the restrictions already in place," she said, commenting on the impact of marketing restrictions on medicine prices.
For his part, Head of the legal department of Sanofi in Ukraine Oleksandr Yanev said "the application of the category of 'promotional services' to the relationship between manufacturers and pharmacies is conceptually incorrect and the introduction of new regulations regarding the obligations of business entities in the field of the sale of medicines, in particular, the definition of the terms 'promotional services' and 'contracts, the subject of which is the provision of promotional services,' which are terminologically uncertain and legally inconsistent, 'causes justified concern in the professional community."
"The formulations enshrined in the law [on medicines] contradict the basic principles of industry regulation. In particular, in the current practice of carrying out promotional activities, concluding contracts with pharmacies is not necessary or legally stipulated. The promotion of medicines is, in essence, a systematic activity of medical representatives of pharmaceutical companies to inform a professional audience, and not to provide services that could be formalized in the economic and contractual field between pharmacies and manufacturers," he said.
Yanev said "the European regulatory tradition clearly distinguishes between promotion and marketing."
At the same time, in good practice, promotion involves professional interaction exclusively with doctors and pharmaceutical workers, while the patient as the recipient of information is excluded, and advertising does not belong to this activity. The issue of promotional activities is already regulated in Law On Medicines No. 2469-IX of July 28, 2022, which, although not yet put into effect, is more thoughtful in terms of definitions and principles of interaction. In addition, the Ministry of Health is working on guidelines on good promotion practice, which is harmonized with European approaches.
"Not only does it not correspond to established professional practice, but it also creates new risks – both legal and compliance risks. In the long term, such regulation will require correction or harmonization with already adopted but not yet effective regulatory acts," he said.