Washington D.C.-headquartered Advanced Medical Technology Association (AdvaMed) launched a Code of Ethics on interactions with health care professionals in India. It provides medical technology and diagnostics makers with compliance principles and guidance that address key legal risk areas governing business relationships and activities.
This Code is intended to help companies make reasonable and appropriate decisions that align with the Code’s cornerstone values of Innovation, Education, Integrity, Respect, Responsibility and Transparency.
While India’s Department of Pharmaceuticals has prepared the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP), a code that guides relationships and interactions with health care professionals for the medical device companies was missing.
The AdvaMed India Code aims to drive cognizance on the unique requirements of the medical device sector with respect to training and clinical research. The AdvaMed Code has considered provisions of the UCPMP, Medical Council of India guidelines, local anticorruption laws in India, U.K., and the U.S., along with the specific requirements of medical device companies.
Broadly, the Code lays out seven elements of an effective compliance program:
- Effective lines of communication (including an anonymous reporting hotline)
- Effective training, education, and communication
- Appropriate oversight and management of the compliance program
- Standards enforced through disciplinary action
- Prompt response to detected problems and corrective action undertaken
- Written policies & procedures that incorporate and foster compliance with the Code
- Internal risk assessments, monitoring, and auditing
It also recommends that programs should be appropriately tailored for each company.
