Return on Investments or Return on Trust?

Late last year, through a notification dated 10th December, 2009, Lt. Col. (Retd.) Dr. A.R.N. Setalvad, Secretary, Medical Council of India, vide memorandum no.MCI-211(1)/2009(Ethics)/55667, issued regulations to amend the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.

The Code of conduct relates to doctors and professional association of doctors and pertains to their relationship with pharmaceutical and allied health sector industry. It asks doctors and their associations (read spouses, assistants, hospital departments where the said doctor calls the shots, pseudo-organizations/NGOs/”citizen groups” and the likes of those) to say a firm NO to financial support offered by pharmaceutical companies. These include gifts and/or grants (cash and kind), sponsorships that include travel, hospitality, conference participation etc.

It also asks medical professionals to make sure that they “maintain professional autonomy” and “affiliation” when dealing with the industry. This means that doctors must not become company spokespersons and also not endorse pharma companies or their brands when advising, consulting or addressing colleagues in formal settings even while merely discussing disease and related treatment trends. Doctors are also asked to ensure that all industry supported research work be approached in a transparent manner such as declaring financial interests, getting their work approved through the relevant ethics committee. This research work must then be made public through appropriate scientific bodies or published in appropriate scientific journals in a “proper way”.

What made the MCI issue this notification?

Trust Deficit
Recent developments such as Pfizer and Eli Lilly being fined billions of dollars, for promoting brands in indications that were off-label, created a stir amongst the lay public and caused BigPharma’s trust to dangerously erode. Like any other, the pharma industry cannot operate without public trust. But the key question is whether the solution is to bring in more regulation? As I had written earlier, in the financial industry, we have regulators who look after consumers’ interests. In short, it is because we do not trust the financial industry, and the fiasco of the last year is a case in point. Given the negative reputation this industry has, we all understand why they are tightly regulated, and most would welcome an increase in the amount of regulation they face. However, why do we need to have the pharma industry so tightly regulated? And perhaps more alarming, the level of regulation in pharma has increased in recent years. Is it time to reverse the trend with regulation in the industry? Perhaps, but maybe we need to get our house in order first.

The pharmaceutical industry is a R&D-based scientific one, identifying, developing and manufacturing products that improve the quality of life for people. On this basis, governments should do everything they can to accelerate the industry’s ability to bring, nay rush, innovations to market. However, it has demonstrated on numerous occasions that its drive for profits might be exerting a greater influence on decisions than the desire to save lives. Therefore, it is fair to assume that heavily regulating the industry is aimed at protecting the vulnerable public from profit-chasing companies. Unfortunately, despite the lives the industry saves and improves, it is amongst the least trusted industries.

Conspiracy Theory
Apart from the more important issue of trust, this move by the Medical Council of India is likely to have been prompted by a number of issues both global and local. I am likely to wager that developments such as the ones listed below had an influence on the MCI notification.
(i) Penalization of BigPharma in the US and EU — Pfizer and Eli Lilly were fined billions of dollars for promoting their brands in indications that were off-label
(ii) BigPharma’s “emerging markets” strategy – large pharma MNCs have begun to focus on fast-growing countries such as Eastern Europe, China, India, Indonesia and Taiwan to offset sluggish growth in developed countries such as the US, EU and Japan.
(iii) Potential alliances with Indian branded generic companies – the decreasing number of new and better medicines, loss of patent protection on drugs accruing sales of billions of dollars.

It is also likely that the US Healthcare Reforms encouraging reduction in costs of healthcare are driving such alliances with the world’s best manufacturers of low-cost, high-quality generic medicines. After all, the highest number of US-FDA approved manufacturing sites outside the US are in India!

Conspiracy theories aside, we cannot brush away the issue that started it all — trust of the lay public (and hence the state). The pharmaceutical industry has lost the one thing that is more important than anything else: trust. It could be so different! It is not too late to rebuild and regain trust. Pharma executives need to learn to do what very few others remember: tell the truth, and act in the interests of the public that it serves, not just shareholders. The public understands investment; it happens in every industry. Investing in as transparent a manner as possible can help companies return public (and state) trust along with cash on those investments.

To regain trust, companies — or the industry at large — need to go beyond what they state – and they are best placed to do this. They should be honest about the results of their research, seek innovation in areas where it is needed, and be more conservative about safety than the authorities and the public. It is time to swing the pendulum in the other direction. The public are increasingly finding it difficult to deal with an overly commercial pharmaceutical sector. The MCI notification has sent strong signals through its notification — for those that care to take note.

3 thoughts on “Return on Investments or Return on Trust?

  1. Mr.Salil, I hope U must be remember that few years back means around 1980-1990 when any pharma representative went to meet doctors at that time used to give a respect him due to his knowledge of product. You are thinking that why I am quoting this now because now a day our market spoils by our gifting, sponsorship etc…. We are not giving benefits of our product or we are not trying to improve our product coz by giving money our customer is ready to compromise on quality of product. But it’s only for short time and that time has gone . I would like give one example that now Indian pharma company are making alliances with MNC for quality of product like vildagliptin in diabetes market for this NOVARTIS partner with two companies like USV Ltd and NICHOLAS for marketing of innovative product . Also ROCHE has partner with USV for anti obesity product XENICAL. Now for this qtr strategy no. of companies are changing their weapon after MCI guideline

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  2. Salil,
    In the light of the recent sacking of the MCI chief and reconstitution of the body,it is appears that t the MCI guidelines were not based on the ” lack of trust factor” , but was no doubt a weapon to probably be used selectively against a few pharma companies or entities with non altruistic motives in mind…
    The govt. did well in moving fast to restore faith in the body…

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  3. Ethical Marketing Practices involve the dissemination of unbiased scientific information that enables clinicians to make decisions that deliver better patient care.

    The impact of MCI guidelines will take time, much as the law enforcing banning of smoking in public place did. The public by and large are unaware of the impact of unethical promotions on their treatment cost and quality. It will take a long term campaign that involves all stakeholders to come to together and agree on what is acceptable and what is not.

    There are unethical promotions in all industries — but the unethical practices in healthcare involving healthcare professionals — doctors;pharma;medical devices;chemist;myriads of other players affects the lives of people directly and hence needs to be monitored carefully.

    Alternatives should be planned after a new set of guidelines is issued; right now there is lot of confusion.

    Plus the man who started it all Ketan Desai is behind bars and MCI itself dissolved and a new committee has been named.

    Meanwhile discussions like this should help in clarifying issues surrounding MCI guidelines.

    Over the years gifts and other goodies also meant that the quality of pharma field sales professionals declined greatly as these were reduced to mere couriers/carriers of gifts. This has to change — the quality of pharma field sales professionals, the people who ultimately CONVERSE with the doctors everyday has to undergo a qualitative change and the doctors need to be re-engaged on a new paradigm that will involve progress to the patient and his relatives, professional satisfaction to the doctor and of course profits to the service providers like pharma and others.

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