The Uniform Code of Pharmaceutical Marketing Practices (UCPMP), launched by the Department of Pharmaceuticals (DoP) has not roused much interest among pharma firms. If it becomes mandatory after DoP’s review post June, will UCPMP’s future implementation remain more on paper than practice? By Sachin Jagdale
The pharmaceutical industry has always found itself in the docks with respect to ethical marketing practices. Though never accepted by industry, many companies have frequently been caught offering gifts to doctors to increase prescription and thus sales. This ‘influential treatment’ of doctors by pharma companies has kept them on the radar of government watchdogs as well. The Department of Pharmaceuticals’s (DoP) Uniform Code of Pharmaceutical Marketing Practices (UCPMP), which came into effect from January 1 this year, is aimed at detecting and stopping such malpractices.
So far, not so good
Most pharma companies promised to adhere to the UCPM. But if industry observers are to be believed, the response to the Code is perhaps out of compulsion, not commitment and so far, it is not so good. According to them, the government is doing what it is supposed to do and pharma companies are doing what they need to do to keep business afloat.
“The response from the pharma industry indicates a cautious outlook towards specific points. For example, there has been a drastic drop in sponsoring Health Care Practitioners (HCPs) to attend Indian and international conferences which has been specifically mentioned in the UCPMP guidelines. While Indian companies are relooking at the way they have been engaging with the doctors, MNCs are also re-looking at their HCP engagement policies to comply with the new guidelines laid by UCPMP,” opines Dr Somnath Datta, Business Unit Head – Critical Care Sales and Marketing, Mylan Pharmaceuticals. Initially voluntary for a period of six months, it will be up for review this June. Unsatisfactory compliance with the UCPMP (the Code) could force DoP to make it mandatory. However, will the transition from voluntary to mandatory make any difference?
Amit Karkhanis, Partner KayLegal and Associates LLP, says, “I personally feel anything that is voluntary does not work in India except for a few pharma companies who have been in business with international companies in the US. They follow the US FDA norms and may adopt this as most of the provisions are based on the US norms. However, small and medium size pharma companies who are part of the large unorganised sector, may not voluntarily follow the code. Hence, I feel that the code should be made mandatory.”
The DoP had come up with the voluntary code of conduct for the industry in 2011 as well, which could not be implemented due to non co-operation by pharma companies. This apprehensive behavior by the pharma companies was an indicator of the fact that offering gifts has been an integral business policy within the pharma industry. It does not seem much has changed since 2011 and so, once again the success of the Code cannot be assured as pharma companies feel that it will erode their business.
Datta says, “In the short term, UCPMP will affect the business of pharma companies. If strictly implemented, this will entail a palpable change in the way marketing of prescription medicines happen throughout India. The HCPs will take time to understand this new way and certain companies with a highly “transactional” model of sales will find it difficult to sustain the sales revenues in the short term. Those companies who have not relied on scientific promotion as a base for ethical promotion will have to revamp their sales training and recruitment policies to hire sales representatives with better communication and convincing skills.”
Will the Code be effective?
Even if DoP makes the Code mandatory, considered the most possible scenario once the voluntary period gets over, its success is doubtful. The strictest of laws will not be effective if pharma companies decide to find new ways of favouring doctors.
Datta says, “After the tobacco industry, the next most hated industry is pharma. I am certain that various countries are slowly realising the problem of conflict of interest brought in by the benefits pharma companies offer to HCPs. Innovative medicines would still need change in prescription behaviour which would mean advertising the benefits of the new therapy. However, unnecessary advertisement of generic medicines just to increase prescriptions should be curtailed. It is possible if government mandates all advertising and promotions to be approved by a central body before being implemented. Just as UK laws are making it difficult for individuals to find cigarettes in the newspaper stalls, companies will also get discouraged if they are mandated to take approvals from government every time.”
Doctors share as much responsibility for making the Code successful. Lack of takers will obviously reduce the scope for givers. However, over the years, a large chunk of the doctor community has supported this ‘gift culture’. Commenting on the ‘cordial’ relations between doctors and pharma companies, a senior official from one of the largest organisations that represents doctors across India, on the condition of anonymity, sarcastically says, “It is not possible to stop pharma companies from offering gifts and doctors are also not going to stop accepting them. No diktat, either from the government or from organisations like ours, will work in this case.”
Global scenario
“In foreign countries, pharma companies have to adopt strict disclosure norms. The parameters laid down by US FDA are very stringent and they govern not just the marketing aspect of pharma companies but manufacturing aspects as well. The US FDA carries out regular inspection of factories of the pharma companies which operate in US and also factories located overseas. We have seen recently in the case of Ranbaxy as to how the US FDA has penalised Ranbaxy for maintaining units in India. Such stringent norms help build a transparent pharma sector which ultimately results through disclosing norms and the consumer benefits from the same,” informs Karkhanis.
Comparing the UCPMP with its US and EU counterparts, Datta says that it is stringent enough but it lacks clarity in many important aspects. As he explains, “Both US and EU codes are already in place. The UCPMP code in its current format, is as stringent (if not more) as the US codes. However, it does differ in certain places. For example, the place of jurisdiction has not been mentioned in the UCPMP. This means, if an Indian company is caught flouting the UCPMP code in a foreign country, will the Indian Ministry take any action? Also, the penalties are not mentioned in the code. Without providing details of the penalty, I am sure the punishment for flouting the Code is left to interpretation and negotiation.”
Making it officially legal?
If compliance with the Code is difficult for the industry, should the government consider legalising the practice of offering gifts? Datta doesn’t think so. He asserts, “Offering gifts should not be legalised.”
However, Karkhanis points out that some clauses in the Code are unjustifiably stringent and will do more harm than good. For example, updation of knowledge is a continuous process for doctors and if pharma companies sponsor them for conferences, seminars or training sessions, it should not be termed suspicious. This updation of knowledge also benefits patients.
Karkhanis opines, “I feel that totally banning gifts and benefits to doctors from pharma companies may not achieve the desired purpose. A complete ban may result in a cash economy which will be totally unregulated and beyond any control. Instead of encouraging (such a) cash economy, it is advisable to set a limit for pharma companies for giving gifts and benefits to doctors. A benefit of sponsoring doctors for conferences and seminars is worth considering as it is important for them to be in touch with latest technologies, knowledge and development s in science and medicine. Presently, the Medical Council of India’s (MCI) code of ethics prevents pharma companies from sponsoring doctors to attend these seminars and conferences which according to me is stringent and harsh and needs to be reconsidered as doctors need to understand the latest technology which shall help them compete globally.”
Datta and Karkhanis both want some key changes in the Code. While Datta asserts that it should have differential treatment for innovative and generic medicines and the penalties for breach of code, Karkhanis feels that Section seven pertaining to relationships with HCPs is too harsh and needs to be diluted. A corresponding dilution in the MCI Code of Ethics is also required.
The Code’s voluntary period will expire in June, after which DoP will have to take a call on whether to turn it into statutory code. However, before taking any final decision, DoP will have to answer a plethora of queries from the pharma industry.
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