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JOINT DECLARATION

of the Czech Medical Association of J.E. Purkyně (Česká lékařská společnost Jana Evangelisty Purkyně)
and
the Association of Research-Based Pharmaceutical Industry (Asociace inovativního farmaceutického průmyslu)

 

on cooperation between healthcare professionals
and the research-based pharmaceutical industry

 

Introduction

  1. Healthcare professionals, represented by the Czech Medical Association of J.E. Purkyně (ČLS JEP), and the pharmaceutical industry, represented by the Association of Research-Based Pharmaceutical Industry (AIFP), being aware of their responsibilities towards patients and society, consider it important to unify the rules of their mutual communication and cooperation. The parties hereby agree to exert their joint efforts to ensure and comply with these rules.
  2. Both parties consider their mutual cooperation to be advantageous and necessary in all phases of development of medicines and their use by patients. Ensuring safety and efficiency of their treatment is the common interest of healthcare professionals and the pharmaceutical industry.
  3. The parties intend to base their mutual cooperation on key principles, namely ensuring high ethical standards, while respecting the patients' interests and expectations of society, and primarily respecting independence of both parties in their respective activities.
  4. Both parties are aware that absolute transparency is vital for ensuring independence and credibility of both parties. Therefore, the parties intend to identify situations that could lead to or could be perceived as a conflict of interests.
  5. Both parties acknowledge that the competent governmental authorities have already stipulated numerous aspects of the mutual relations between healthcare professionals and the pharmaceutical industry in national and international legal regulations. The parties have also voluntarily agreed to comply with the ethical principles in their respective codes of conduct. The joint declaration of ČLS JEP and AIFP does not affect any existing legal regulations or codes of conduct. However, beyond the framework of the above, the joint declaration sets the main principles of ethical conduct and behaviour in the mutual relationship between healthcare professionals and the pharmaceutical industry. Both parties consider it desirable to comply with these principles in any mutual cooperation.
  6. The joint declaration stipulates the following main areas of mutual cooperation:
    1. Information on products and promotion of registered medicines
    2. Meetings organized or sponsored by the pharmaceutical industry
    3. Clinical research
    4. Consultancy services and cooperation
 

INFORMATION ON PRODUCTS AND PROMOTION OF REGISTERED MEDICINES

  1. Information provided by the pharmaceutical industry to healthcare professionals is important for providing patients with high-quality pharmacotherapy. It is necessary to guarantee independence in adopting medical decisions. The contents of the information and promotional materials must be true and accurate.
  2. Therefore, both parties agree to comply with the following principles:
    The pharmaceutical industry agrees to:
    1. provide true and updated information on its products, including information on advantages and disadvantages of the products on the basis of the current scientific evidence,
    2. ensure that business agents and other pharmaceutical industry staff providing information are appropriately qualified and trained,
    3. provide physicians, on their request, with clinically relevant scientific data on the products,
    4. monitor scientific and clinical reports on new medicines after introduction thereof to the market and notify physicians without delay of substantial additional findings, if any,
    5. refrain from publishing advertisements for a new medicine prior to its registration.
    6. on the contrary, the pharmaceutical industry may not offer unjustified hospitality; any gifts and benefits should be inexpensive and must be relevant for medical practice.
    The healthcare professionals agree:
    1. not to request the provision of gifts and benefits from the pharmaceutical industry,
    2. not to accept unjustified hospitality; any accepted gifts or benefits should be inexpensive and must be relevant for medical practice,
    3. report undesirable side effects of medicines.
 

MEETINGS ORGANIZED OR SPONSORED BY THE PHARMACEUTICAL INDUSTRY

  1. Pharmaceutical companies may organize or sponsor meetings of physicians. The contents of such events must be clearly educational. Information provided at any meeting must follow from scientifically and medically relevant data.
  2. Educational activities that form part of systematic postgraduate education of physicians should be evaluated and accredited by the competent institutions.
  3. The purpose of a meeting must be clearly indicated in an invitation to or notification of the meeting. If registration or accreditation is required for a meeting, this fact must be indicated.
  4. The place of a meeting should be appropriate to scientific purposes and should not require longer travel than necessary.
  5. The pharmaceutical industry may pay the costs of lectures, study materials and equipment necessary for a meeting. It may also cover travel expenses and accommodation for participants in the meeting, but not for accompanying persons.
  6. Hospitality during a meeting should be generally acceptable, reasonable and strictly limited to the purposes of the meeting. Sponsoring or organizing sports or entertainment events shall be prohibited.
  7. The principles set forth in this Declaration shall also be applicable to activities carried out outside the Member States of the European Union if physicians from the EU Member States participate in the activities.
 

CLINICAL RESEARCH

  1. 16. Both parties consider cooperation between the pharmaceutical industry and healthcare professionals in the performance of clinical evaluation and pharmacoepidemiological and pharmacogenomic studies to be necessary for development of medical products, thorough familiarization therewith and optimum use of the experience and knowledge for the benefit of patients.
  2. Both parties agree to comply with the following principles in each clinical testing:
    1. All persons participating in clinical evaluation must adhere to ethical and professional principles and guidelines such as the Declaration of Helsinki1 and the Good Clinical Practice2.
    2. Each evaluation must have a scientifically and therapeutically relevant aim. No evaluation may be performed purely for promotional purposes. The aim of an evaluation must always consist in improvement of medical treatment, diagnostic methods or medical knowledge with the highest possible benefit for patients.
    3. The aim of an evaluation must be set in advance. Evaluation protocols must be drawn up in such a manner so as to allow achievement of the aim of the evaluation and (verification of?-trans.) validity of the conclusions of a study.
    4. Patients participating in an evaluation must be informed of the sponsor of the evaluation.
    5. Physicians may not receive any payments or other benefits for recommending a patient for participation in clinical evaluation.
    6. However, physicians shall be entitled to remuneration for their work in the evaluation. Any remuneration must be based on the work performed and must be notified to the ethics commission reviewing the clinical study protocol. The remuneration must be independent of the expected results of a study.
    7. All results relating to efficiency and safety of distributed products should be correctly published, irrespective of the achieved conclusions, at least in the form of a list available on the Internet and within one year of registration of the relevant medicine. Other clinically relevant findings should also be published accordingly.
    8. Publications, lectures and other presentations must indicate the sponsor of the clinical evaluation.
    9. Physicians shall be entitled to remuneration for presenting lectures on clinical evaluation and the results thereof.
    10. In presenting the results of evaluation, physicians must indicate their relationship with all companies concerned with the specific pharmaceutical area.
1 The Declaration of Helsinki (World Medical Association)
2 The ICH Good Clinical Practice (International Conference on Harmonization of Regulatory Requirements)
 

CONSULTANCY SERVICES AND COOPERATION

  1. The pharmaceutical industry may ask healthcare professionals to provide it with consultancy services. In this position, healthcare professionals may provide consultancy services or expert opinions to the pharmaceutical industry.
  2. This cooperation must not impair independence and impartiality of healthcare professionals providing consultancy or services; healthcare professionals must always comply with the ethical obligation to make independent medical decisions and fulfill their professional duties for the benefit of patients.
  3. Payments for consultancy services must always relate to the work performed.
  4. If physicians providing consultancy services or participating in clinical evaluation provide third parties with opinions or results that relate to the same medical-pharmacological area as the consultancy or the participation in clinical evaluation, they must declare their interest in this respect in order to ensure transparency vis-a-vis third parties.
 

In Prague, on December 12, 2008

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