Introduction of draft ‘Uniform Code for Medical Devices Marketing Practices'
The Uniform Code for Pharmaceutical Marketing Practices (UCPMP) was notified by the Department of Pharmaceuticals (DoP) in 2014 as a voluntary code to be adhered by pharmaceutical companies in relation to marketing practices. By way of a clarification, the applicability of the UCPMP was extended to the medical devices industry.
On March 16, 2022, the DoP issued a draft Uniform Code for Medical Devices Marketing Practices (UCMDMP). Like UCPMP, this draft is also proposed to be a voluntary code but in relation to marketing of medical devices specifically. The draft has been released for feedbacks, inputs and suggestions by stakeholders.
Some of the important propositions contained in the draft are explained below:
- Definition of Health Care Professional (HCP)
The UCPMP did not define HCP, however, the UCMDMP provides for a very wide definition of HCP. HCPs have been defined to mean any person or entity authorised or licensed to provide health care services, or who is involved in the decision to purchase, prescribe, order, use and recommend a medical device in India. The definition extends to include individual clinicians such as physicians, nurses, technicians, pharmacists, pathologists, lab technicians, etc. and provider entities such as hospitals, pathology labs, blood banks, etc. It also covers within its ambit administrative personnel such as hospital purchasing agents.
- Elaborative and Explanatory
The UCMDMP is elaborate and explains the framework of legitimate dealings between medical device industry and HCPs with specific scenarios and illustrations. This was not the case with UCPMP, which was very concise. Some of these scenarios are briefly set out below:
Companies may occasionally provide modest and appropriate educational items to HCPs that benefit patients or serve a genuine educational function for HCPs. Educational items can include but are not limited to product manuals and anatomical models.
- Training and Educational Programs
The draft UCMDMP contemplates that HCPs may participate in training and educational programs and events as a faculty, trainer, proctor, delegate or a trainee. The categories and description of such programs and events has been outlined in the UCMDMP. The participation of HCPs is however subject to adherence to conditions prescribed with respect to expenditure by medical device companies on meals, travel, accommodation and honorarium for lectures.
- Cash or Monetary Grants
The educational grants may be provided to training institutes and third-party entities for legitimate scientific, educational and training programs.
For a fair market value, HCPs may be engaged by companies to provide consultancy services for educational purposes and under a contract. Transparency is required to be maintained in such contracts and the company is also required to maintain adequate records for any expenses incurred or fee paid under such contracts.
- Third party events
A strict compliance mechanism is provided to be followed by companies in relation to third party events, which has been defined to mean an independent health care-related educational, scientific, business, and/or policymaking conference, meeting, or event put on by a third party other than the medical device company. This term includes programs that are accredited to provide continuing education credits and programs that are not accredited.
The draft UCMDMP does not permit direct sponsorship of an HCP for such events by medical device companies. HCPs may only be engaged under a professional services agreement for a satellite symposium conducted by the company and HCPs are to be compensated at a fair market value.
- Documentation and Record
The draft UCMDMP requires documentation and record for each of the permitted dealings between medical device companies and HCPs to be well maintained.
In view of recent judicial interventions in relation to dealings between pharmaceutical companies and doctors, much development is expected on this front. A public interest litigation was recently filed in the Supreme Court of India by the Federation of Medical and Sales Representatives Association of India seeking court's intervention to lay down guidelines to control and regulate unethical marketing practices by pharmaceutical companies or in the alternative make Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) binding with reasonable modifications and additions as required. The Supreme Court by way of its order of March 11, 2022 has called the government to respond within 6 weeks.
Further, the recent amendment in the Income Tax law and the decision of Supreme Court Apex Laboratories results in the increase in cost of doing business. The interpretational challenges around availability of input tax credit of GST paid on procurements made for such expenses incurred by pharmaceutical manufacturers further adds up to the cost of marketing.
We can also expect some quick moves on the part of the government to give statutory force to the abovementioned codes and to align the codes for pharmaceutical and medical device.
The above discussed developments will call upon the pharmaceutical and medical device companies to re-visit and align their marketing practices being followed till now.
Having extensively advised clients on this front, we will be closely monitoring all related developments and further advising on all such aspects.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.