Turkish Pharmaceuticals and Medical Equipment Institution (the “Institution”) issued a new Regulation on the Promotional Activities of Human Medicinal Products (the “New Regulation”) which has been published in the Official Gazette dated 03.07.2015. The New Regulation abolishes and replaces the Regulation that has been in effect since 26.08.2011 (the “Old Regulation”).
Save for a number of provisions, the effectiveness of which has been postponed to a later date, the New Regulation has entered into force as of 03.07.2015, the date of its publication (the “Effectiveness Date”).
Key aspects of the New Regulation are as follows:
- Scope of the Regulation has been extended
The New Regulation now incorporated enteral nutrition products and medicinal infant formula alongside of human medicinal products.
- Significant Changes Regarding Product Promotion Representatives
With the New Regulation, each product promotion representative must obtain a certificate of competency from the Institution until 01.01.2019. To be eligible for the above certificate, one must be a graduate of university or 2 yearly higher professional schools and successfully pass the exams organized by the Institution. To be effective as from 01.01.2019, product promotion representatives who hold certificates of competency may be employed in licensed companies and registered as such with the electronic registration system kept by the Institution. A “Product Promotion Representative Identity Card”, which is arranged by the Institution, will be given to the registered product promotion representatives by Licensee/Permit Holder. No product promotion representatives can be employed without such Identity Cards.
There is, however, an exception to the above-explained requirements. Those product promotion representatives who had actively worked at the same post for a minimum periof of 2 years within 5 years immediately before the Effectiveness Date, have the right to obtain the relevant certificate even they are not a graduate of the universities or higher professional schools.
- Beneficiaries of promotion activities are limited
Promotion activities in respect of any human medicinal products may be conducted exclusively for the benefit of doctors, dentists and pharmacists. Providing information to any other health officials for promotional purposes is no longer permissible.
- Most of the powers and authorities of the Ministry have been transferred to the Institution
The Institution has now power to issue required licenses and permits, to organize exams for product promotion representatives, to allow for the announcement of Products, to monitor promotional activities and impose sanctions in case of any violations of the rules governing promotion activities.
- Liabilities of license/permit holders are detailed and outsourcing promotion activities are permitted
Provided that license/permit holders meet certain conditions, outsourcing of promotion activities is allowed. However, outsourcing does not reduce or remove their liability.
License/permit holders are required to inform the Institution of their engagement of any service provider for undertaking promotional work on their behalf. They shall submit the written agreements which they had executed with service providers before the Effectiveness Date, to the Institution within 6 months as from such Date.
In addition, licensee/permit holders shall, within minimum i) 15 business days in advance of any meeting to be held locally and ii) 30 business days in advance of any meeting to be held abroad, inform the Institution of the planned scientific meeting or product promotion event they intend to organize or contribute. In this context, they shall also notify the Institution of the subject matter of the planned meeting, expected participants’ list, items of expenditure and planned activities (Article 11/3, 4). Furthermore, within 30 business days after the holding of the subject meeting or event, as appropriate, lists of the actual participants, actual cost incurred and activities undertaken shall be notified to the Institution.
They are also obliged to keep records and samples of free specimens and promotional equipment they use, any data and documents in relation to promotion activities they conduct and product promotion representatives they employ.
- New Rules Regarding Scientific Meetings and Product Promotion Events
With the New Regulation, license/permit holders can now cover registration, travel and accommodation expenses of health professionals participating in local and international scientific events subject to certain conditions. University students and students of two yearly higher professional schools can also attend to scientific meetings that are sponsored by license/permit holders.
Scientific meetings to be held abroad can be organized or supported by license/permit holders, provided that such meetings have international qualities/aspects or the majority of participants are health professionals who work in foreign countries. To be effective as from 01.01.2016, presentations or educational videos that are prepared by the Institution shall be presented at the meetings organized or supported by licensee/permit holder for the purpose of increasing awareness about pharmacovigilance.No scientific meeting or event can be organized or supported at seaside holiday destinations and at ski resorts between the dates of 1st December and 1st March. Similarly, such meetings or events shall not be organized or supported at seaside holiday destinations between the dates of 1st June and 1st September for the years of 2015 and 2016; and between the dates of 15th June and 15th September for the year of 2017 and after.
Scientific meetings organized or supported by the Ministry are excluded from the above-explained restrictions.
- New Sanctions are introduced for breach of rules
Same with the Old Regulation, in case the rules governing promotional activities are breached by license/permit holders on a repeated basis, violators are banned from conducting promotional activities. The New Regulation regulates that in order for an increased sanction to be imposed, the repeating violation should have been made within 1 year following the imposition of the applicable sanctions for the first violation. Concurrently, with the New regulation, repeating a violation after the lapse of one-year will not result in increased sanctions. In addition, new sanctions are introduced for violating rules governing the scientific and promotional meetings.
- New Rules on Sponsorship
With the New Regulation, license/permit holders are allowed to sponsor not only public health organizations and institutions, but also non-profit healthcare organizations subject to certain conditions.
Same with the Old Regulation, no prior permission of the Institution is required in this respect. Nonetheless, under the Old Regulation licensee/permit holders were required to ask themselves for prior permission from management of the recipient organizations. This requirement is now removed by the New Regulation. Instead, recipient public health organizations/institutions shall internally ask for prior permission from the higher authority they report to i.e., Ministry of Health in case of state hospitals, and relevant university administration in case of university hospitals, before accepting any sponsorship or donation.
On a different, but related subject, health professionals who receive any kind of support from license/permit holders shall declare such support, i) at the end of each scientific articles they write and ii) at the beginning of each presentations they make.
Apart from the foregoing, the New Regulation introduced the concept of value transfers which may be made by license/permit holders besides extending sponsorships or donations. However, it is unclear what is meant by value transfers, and in particular what differences they have as compared to donations. This issue is yet to be clarified.