The importance of "ethics and compliance" in the healthcare industries, and particularly in the pharmaceutical and vaccine industry, as well as the importance of gaining the trust of the public and regulatory authorities, has once again been recognized by all stakeholders in the last three years.
Under the umbrella of the Association of Research-Based Pharmaceutical Companies, there are three main structures working in the field of ethics and compliance:
1. Ethics and Compliance Strategic Management Committee (E&C SMC) reporting to the AIFD Board of Directors
2. Ethics and Compliance Good Practices Committee (E&C GPP), which brings new topics and suggestions to the Ethics and Compliance Strategic Management Committee, discusses new perspectives and solutions to the compliance problems faced by companies by referring to the Promotion Regulation, AIFD Promotion Principles, Promotion Supervisory Board (CPP) decisions, and has three representatives from each member company as permanent members
3. the Code of Promotional Practice Review Panel (CPP), where conduct and activities alleged to be in breach of the AIFD Code are dealt with upon application or ex officio.
All three structures are supported by AIFD Legal Advisor and AIFD Ethics Advisor. E&C SMC proposals are also reviewed by the Legal Group of the Board of Directors when deemed necessary by the AIFD Secretary General.
- In 2022, the E&C GPP met four times, the E&C SMC met eleven times, and the E&C SMC management team and consultants also held an online meeting with TITCK on December 21, 2022.
-TITCK published the Guideline for the Application for Scientific Meetings and Product Promotion Meetings under the Regulation on the Promotional Activities of Medicinal Products for Human Use, applicable as per 11 August 2022 and although this new Guideline includes electronic meetings, it was not announced that the Guidelines for the Application of Electronic Scientific Meetings and Electronic Product Promotion Meetings published on March 14, 2021 was repealed as this guide remains valid to be applied to meetings held electronically only.
- The International Congresses approval mechanism, called Congress Vetting System (CVS) which is carried out jointly by EFPIA and MedTech Europe, entered into force as a pilot in 2021 and as binding from the beginning of 2022. If international face-to-face and hybrid health congresses with 500 or more participants, attended by healthcare professionals from at least 5 countries, are not approved by the EFPIA/MedTechEurope Congress Evaluation System, AIFD member companies should not support these meetings.
- In order to overcome the difficulties in organizing and supporting Disease Information Events, direct or indirect discussions were held with the TITCK Rational Use of Drugs (RUD) Department several times during the year. In 2023, a Guideline on this subject is expected to be prepared.
- In the meetings held between the E&C SMC management under the chairmanship of Dr. Ümit Dereli, Secretary General of AIFD, and the TITCK RUD department, the attitude of the Agency regarding the strict adherence of Product Introduction Meetings to the SmPC text was discussed. We are still waiting for an approach that will allow Phase 4 studies carried out after the publication of SmPC to be shared with physicians.
-E&C SMC conducted besides its monthly meetings, the first quarterly
E&C GPP meeting in March 2022 where all members companies were invited.
The highlight of the March 2022 E&C GPP meeting was the an automation
algorithm presented by one AIFD member company, to speed up data entry to
the TITCK database where names of supported HCP participants need to be
entered. The automation program was reported to reduce data entry and data
correction period by at least 75%. The program was very welcomed.
-A High Court decision about the acceptance as tax-deductible company
expense of payments made on behalf of sponsored HCPs was shared with all
members as a reference for similar tax cases in the industry.
- A guide titled Service Procurement from Physicians under Revolving Fund was drafted. It is planned that this guide will be finalized in 2023 and announced to the members.
-An online meeting was held on December 21th, 2022 with the participation
of the AIFD Ethics & Compliance SMC Chair and the Department of
Rational Drug Use of TITCK where we exchanged the AIFD-IEIS aligned views
(with minor exception) on the need for a local guidance for Disease
Awareness Programs funded by the pharmaceutical companies. We reviewed and
discussed the proposed framework details as the AIFD&IEIS joint
recommendation in line with respective EFPIA guidance that we had already
presented in the previous meeting. The head of Department of Rational Drug
Use of TITCK shared her positive feedbacks and stated that they will be
considering the proposed framework further in detail.
-As a second topic, the complications that both parties have been facing in
the meeting application system that result in serious delays in the process
was discussed and it was decided to hold a training to be organized by
TITCK for the pharma companies on the “meeting application system of
TITCK”. With this training, it is aimed to develop a common understanding
between pharma companies regarding meeting applications to eliminate the
delays. The training to be held in Istanbul, is targeted for February 2023.
-Finally we presented the Q&A Document in the same meeting that we
prepared as AIFD Ethics & Compliance SMC for the “Guidance on
Applications for Scientific Meetings and Product Promotion Meetings”
published on August 12, 2022 and discussed some of the items that need some
further clarification in the Guidance. The Q&A Document on “Guidance on
Applications for Scientific Meetings and Product Promotion Meetings” is
shared with all the AIFD member companies by Ethics & Compliance SMC.
