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?
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.
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.