Dr Milind Antani, Legal and Tax Counseling Worldwide & Anay Shukla, Member, Pharma and Life Science team, Nishith Desai Associates opine that a statutory code is required to shift the focus from a ‘HCP-prescription’ driven industry to a ‘patient-impact’ driven industry
In the pharmaceutical and medical device business, no one can overemphasise the importance of promoting drugs and medical devices before healthcare practitioners (HCPs). The whitepaper called ‘prescription’ with Rx is revered like no God is. All pharma and medical device companies hope that their product appears on as many prescription papers as possible by HCP because it works like a ‘purchase order’ in pure business sense. Once a product is prescribed by a HCP, its sale is a mere formality. So it won’t come as surprise to anybody that pharma and medical device companies would leave no stone unturned to promote their products before HCPs.
Pharmacy in India does not have a comprehensive code that governs interactions of the pharma and medical device industry with HCPs like many developed jurisdictions have. It has, however, a code that seeks to regulate the promotion of drugs and medical devices before HCPs. The code is called Uniform Code of Pharmaceutical Marketing Practices (UCPMP) and has been published by the Department of Pharmaceuticals (DOP). Because of the origin of the code, it is sometimes informally referred to as DOP Code as well.
The UCPMP has been published for voluntary adoption and compliance so far. However, a closer look at its provisions make it clear that its voluntary nature is a hogwash. It is as mandatory as any other guideline which does not have a statutory backing would be. Unfortunately, as mandatory as it may be, it is just teeth that possibly cannot bite. It does not have any penal provision which would act as a deterrent to a company. Not to forget, the UCPMP is based on the principle of self-regulation. The penalties prescribed under it, while insignificant, are supposed to be imposed by the industry association. Nothing speaks more of the success of self-regulation than the fact that since the publication of UCPMP, not even a single pharma or medical device company has been officially reprimanded by an industry association for violation of UCPMP.
The UCPMP prohibits sponsorship of hospitality and travel of HCPs for attendance of conferences and workshops in capacity of delegates. However, since UCPMP does not have a statutory backing, it is openly flouted. The UCPMP also prohibits pharma and medical device companies from providing gifts to HCPs. However, HCPs do accept gift under various disguise. The short point is that the UCPMP has not succeeded well as not all companies have complied with. There are many companies who strictly abide by UCPMP and have developed policies around that.
It is expected that the government will sooner or later introduce a statutory code that mandates the same things as are mandated by the UCPMP, but with a penal consequence attached to it. So, is that good or bad for the pharma and medical device industry?
We believe that it will be very good for the industry for the following reasons. The pharma industry and medical device industry will move from a ‘HCP-prescription’ industry to ‘patient-impact’ driven industry. When there will be little scope of influencing the judgment of HCP, the industry will focus on bringing better quality and affordable drugs to the market. The playing field will level and all serious players will stand to benefit. Not to forget the easing off on burden on the pocket of the common Indian who today is ignorantly paying for the promotional activities of pharma and medical companies.
Like any medical pill, the UCPMP has its side-effects as well. Genuine training efforts of companies, especially those in medical devices sector, are being hindered because of the restriction on sponsorship of travel and hospitality. Keeping HCPs abreast with developing science and technology is in the interest of public at large. However, very few HCPs are willing to spend money from their own pocket to attend training sessions in India and abroad. Consequently, advanced medical device companies are unable to sell their products in India. This happens to be the single biggest grouse of the medical devices companies with UCPMP but they are helpless. When UCPMP because statutory, medical device companies will be able to approach the court of law to strike down such a restriction on the ground of excessive restriction on their right to carry out business. It is likely that the court may take a sympathetic view on the grounds of public interest.
A statutory code will also ensure transparency and accountability in the administration code. The decisions given will be bound by principles of natural justice and fair trial. All decisions will be published. The aggrieved party will have an avenue to approach the court of law if due process is not followed. By relying on precedents, the industry will be able to see future path very clearly.
Today, under the current form of UCPMP, there seems to be no future path. All roads lead to the shady past which weighs heavily on at least the new generation of pharma and medical devices companies who are global, or aspire to be global, and who would rather invest in quality of their product than over a HCP.
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