Year : 2010 | Volume
: 1 | Issue : 2 | Page : 49--50
Balancing profession and perceptions
Director - Medical & Regulatory Affairs, Pfizer Ltd
Director - Medical & Regulatory Affairs, Pfizer Ltd
|How to cite this article:|
Potkar C. Balancing profession and perceptions.Perspect Clin Res 2010;1:49-50
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Potkar C. Balancing profession and perceptions. Perspect Clin Res [serial online] 2010 [cited 2020 Feb 26 ];1:49-50
Available from: http://www.picronline.org/text.asp?2010/1/2/49/71849
Medical Council of India (MCI) notified an amendment to its prior Code of Ethics in the Gazette on the 14 th of December 2009. The amendment with legal jurisdiction on healthcare professionals is expected to control gifts, travel/ entertainment, hospitality, cash and monetary grants, research and physician endorsements. With this amendment, MCI is said to have taken a definitive step towards restoring the balance in interaction between healthcare professionals (HCPs) and pharmaceutical/healthcare industry and improve the image of the Medical community in this country. This amendment also propels India to the leadership position in regulating the interface between pharmaceutical/healthcare industry and medical profession.
Will MCI be successful in achieving its intention?
Before we address this question, let us look at key recommendations of this amendment:
Gifts - Amendment institutes complete ban on giftsTravel - No travel support from pharmaceutical/healthcare industry permitted except for speakers, consultants, advisors and investigatorsHospitality - No individual hospitality permissible for self/ family membersCash & monetary grants - No individual cash/monetary grants allowed except through approved institutions in a transparent manner with appropriate disclosureMedical research - Research can be conducted only after applicable regulatory, legal and other approvals. A medical practitioner's freedom to publish data emphasized.Endorsements - No public endorsements of drug permitted.
These amendments with significant restrictive mandate, suggests MCI views punitive measures are necessary for controlling prevalent noncompliance. MCI's intention of creating a healthy balance in interactions between the industry and HCPs is laudable. Both industries as well as HCPs overlap in their common objective of improving patient care. This makes it necessary that this intention be translated in practice.
These amendments raise following questions that need resolution to ensure intention is translated in practice.
1.Professional development of HCPs
Implementation of amendments without an operational continuing medical education (CME) system in place, may impact continuing education of practicing physicians. Healthcare/Pharmaceutical industry is the major sponsor of medical education in this country. While the intention to free medical education from healthcare/pharmaceutical industry (a stakeholder with conflict of interest) is welcome, a framework for continuing medical education must be implemented at the earliest.
2. Differential provisions for delegates versus affiliates
Amendment allows for travel and hospitality for Speakers/ Advisors/Consultants/Investigators, while this is prohibited for delegates. This discrimination is believed to be intentional for recognizing the contribution of services by affiliates. This discrimination is unlikely to contribute much to restoring the balance in industry-HCP interactions.
3. Medical research only in approved institutions
This clause in the amendment has generated a lot of discussion around what is an approved institution. With schedule y permitting clinical research at independent investigators, the debate around approved institution must be addressed. This also raises questions around real world research done by physicians/practitioners not affiliated to any institution. Importance and impact of real world research on clinical practice cannot be emphasized enough. Physicians/ practitioners involved in real world research with appropriate ethics approvals and disclosures through patient informed consent can only improve practice of medicine. Assuming restricting real world research at non affiliated physicians/ practitioners is not the intention of this amendment, a clarification of expectations will help implementation.
4. Emphasis on publication from each participating investigator
ICH and Indian GCP guidelines have stated publication as a requirement. International research practice requires a joint publication in case of a multi-centric trial before individual investigators can publish their own data. This requirement for a joint publication is only to ensure appropriate representation of results from a well designed scientific experiment. This does not imply giving up rights by an individual investigator. Emphasizing this may create avoidable confusion amongst stakeholders including ethics committees.
Reliance on whistle blowers/complaints for identifying noncompliance has been the mainstay of enforcement in Indian Medical Council Regulations of 2002. With these amendments, one of widely discussed concerns across media and other stakeholders has been around its enforcement. Strengthening enforcement may need to be given serious consideration for consistent implementation of these guidelines across India by all stakeholders. Inconsistent implementation can create an imbalance in level-playing-field for different stakeholders.
Pharmaceutical/healthcare industry and HCPs are part of the healthcare ecosystem with different roles. They share the overlapping ultimate objective of improving patients' health. Health policy should therefore be aimed at fostering a healthy relationship between these two key stakeholders in healthcare value chain. Interactions between pharmaceutical/healthcare industry and HCPs are centered around three major areas - research, practice and education. Symbiotic, transparent relationships across these three areas are necessary and a win-win for all healthcare stakeholders.
Relationship between these important stakeholders has been under scrutiny of late. In the context of this, MCI amendment can play a vital role to initiate the discussion around this sensitive topic. Some may question the need for any legislative attempts to restore the balance. A careful consideration should be given to other avenues including strengthening existing self regulation of the industry as well as medical profession, institutionalizing transparency and disclosures and implementing a framework of CMEs for HCPs. Balancing the medical profession as well as perceptions around medical practice is an arduous task. MCI has taken the first step. Building trust through open communication and focus on common objectives will be important for the intention to become a reality.
|1||ICH Topic E 6 (R1) Guideline for Good Clinical Practice. Downloaded from http://www.ema.europa.eu/pdfs/ human/ich/013595en.pdf on 3/17/2010|
|2||Good Clinical Practices For Clinical Research In India. Downloaded from http://cdsco.nic.in/html/GCP1.html on 3/17/2010|
|3||Code of ethics regulations 2002. Downloaded from http://www.mciindia.org/know/rules/ethics.htm on 3/17/2010|