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How new initiative of APRaD will contribute to transparency of Ukrainian pharmaceutical market
Association of Pharmaceutical Research and Development (APRaD),
Kyiv, Ukraine, Tue, May 17, 2016
The Association "APRaD", uniting the largest world leading pharmaceutical companies active in the research and development of new medicines that improve health and quality of life, with a presence in Ukraine, will disclose the information on transfers of value to healthcare professionals and organizations.
The intention of pharmaceutical industry to be more transparent to a wider audience is not a new idea and currently managed by the relevant Disclosure Code, which was developed and accepted by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in 2013. Also, other examples of such high principles of cooperation between pharmaceutical companies and healthcare professionals fixed at the legislation level have been known in the world practice (Sunshine Act, USA).
APRaD, being an affiliate member of EFPIA, actively promotes and encourages ethical business principles and practices among its members and the pharmaceutical industry in general in Ukraine. In 2014, APRaD updated its Code of Pharmaceutical Marketing Practices (hereinafter – the Code) by adding article 14 "On disclosure of transfers of value to healthcare professionals and organizations», which fully corresponds to the international practice.
Hereby, for the purposes of Articles 14 of the Code there was determined a “healthcare organization” as any legal person irrespective of the legal or organizational form or its separate unit, aims at health care of patients and/or provision of medical services to the public based on appropriate licenses and professional activities of medical (pharmaceutical) workers. In addition, healthcare organization includes: medical or scientific associations, learned society (except for patient associations), medical teaching institutions, healthcare foundations and other medical institution whose business address, place of incorporation or primary place of operation is in Europe.
In accordance with the provisions of the Code, healthcare professional is regarded to as any member of the regulatory authorities, medical, dental, pharmacy or nursing professions or any other person who in the course of his or her professional activities may prescribe, recommend, purchase, supply, or administer a pharmaceutical product.
At the same time, “transfers of value” means direct and indirect transfers of value, whether in cash, in kind or otherwise, made, whether for promotional purposes or otherwise, in connection with the development and sale of prescription-only pharmaceutical products exclusively for human use.
The goal of implementation of such an initiative was commented by the EFPIA and APRaD officials and pharmaceutical companies:
Richard Bergström, Director General, EFPIA noted: “Increasing transparency through the individual disclosure of transfers of value is good for everyone, including healthcare professionals because it builds understanding of this important collaboration. When pharmaceutical companies research, develop and introduce new medicines in clinical practice, it requires input from many stakeholders such as health professionals and healthcare organisations. The introduction of the EFPIA Disclosure Code helps to increase understanding of these important relationships.”
“I think that disclosure by itself bring clear communication to patients how pharmaceutical business cooperated with HCPs and HCOs. The essence is in the communicated openness and fairness about pharmaceutical industry marketing practices to the society as a whole.”- stated Oleksandr Boyko, Head of Representative office of Novo Nordisk Ukraine, a Member of APRaD Board of Directors.
“Collaboration between industry and health professionals benefits patients. It is a relationship that has helped deliver numerous innovative medicines and changed the way many diseases impact our lives.” - pointed Andrew Powrie-Smith, Director of Communications, EFPIA.
Therefore, the information on the amount and purpose of payment or grant, or donation towards healthcare professionals and organization will soon become available to the public at the APRaD web-page. The categories of transfers of value, which are also the subject of disclosure, also include contribution to costs related to events - specialized seminars, conferences or symposia on medical topics, covering registration fees, travel and accommodation, and fees for service and consultancy.
First information on transfers of value in 2015 will be published no later than the end of June 2016 using the approved structure for disclosure set forth at the APRaD web-page. Further disclosures have to be announced annually within 6 months and each reporting period shall cover a full calendar year.
Above mentioned information may be disclosed on individual or aggregate basis in accordance with the consent signed by healthcare professionals and organizations. If there is no such consent, the information will be disclosed on a common basis, ie there will be disclosed a total amount of transfers of values given in favor of the recipients and the total number of recipients. Research and development transfers of value shall be disclosed on an aggregate basis only.
By establishing this Code, APRaD strives to provide high ethical principles for the pharmaceutical industry in Ukraine. Disclosure of transfers of value towards healthcare professionals and organizations will allow pharmaceutical companies to comply with the best European standards and provide the additional tool of control on their activity for both - the state and patients.
This is a responsible decision, whereby the patients will receive more objective information about how the pharmaceutical industry works. After all, the decisions taken by healthcare professionals have a direct impact on the patients' lives. Therefore, the maximum openness of such cooperation in Ukraine is one more step to civilized relations between industry and society.
Nevertheless, the main and ultimate goal of the initiative, at which APRAD and pharmaceutical companies aim, is to improve the quality of life and health of Ukrainian citizens.