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In India can there be transparency around the financial relationships of manufacturers (pharma products and devices), physicians, and hospitals? Are the Indian physicians willing to disclose payments they receive from pharma and device manufacturers? Industry answers these tough questions By M Neelam Kachhap

From the time Open Payment database went online in the US, debates on the financial relationships among doctors and industry have erupted everywhere. In India, The Indian Medical Council (professional conduct, etiquette and ethics) regulations, 2002 guides the relationships of manufacturers (pharma & device), physicians and hospitals. Despite the blanket ban on accepting gifts, travel facilities and hospitality from pharma companies in lieu of promoting their products perpetrators find ways to flout the norms.

What is an Open Payment Database?

The Open Payments database is an implementation of the Physician Payment Sunshine Act (PPSA), passed as part of the Affordable Care Act in 2010, requires manufacturers of drugs, devices, biologics, and medical supplies to track and report “all transfers of value” to physicians or teaching hospitals.

MCI Guideline on Payments

The amendment to the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation 2002” has brought out the code of conduct for doctors and professional association of doctors in their relationship with pharma and allied health sector industry which prohibit them from accepting any gifts, travel facility or hospitality, from any pharma company or the healthcare industry.

While the interaction among pharma and device manufacturers and medical practitioners have always been opaque in India, the industry is clearly rooting for greater transparency in its financial relationships. We asked the industry if there can be transparency around the financial relationships of manufacturers, physicians, and hospitals and almost everyone replied in an affirmative. But how can it be achieved and should it be made public is an idea the industry is grappling with.

Experts believe that greater transparency might influence patients’ trust in their doctors. It may also influence the patients’ perceptions of their doctor’s expertise and patient decision-making with regard to selection of a hospital might be affected. Like the issue of black money in India, the issue of transparency in financial dealings in the healthcare industry should be considered serious and dealt with an iron hand. The industry experts share their views.

201411ehm08Yes, there should be and there can be transparency around the financial relationships of manufacturers (pharma & device), physicians, and hospitals. All markups, which are required and pricing of devices as charged by the hospitals must be clearly displayed and informed to the patients in advance. All payments as per MCI and international norms (e.g. honorarium, consultancy with manufacturers, company) should be revealed at appropriate places there is scope for law like the US Physician Payment Sunshine Act (PPSA) in India. Indeed, a law like this is essential for India to curb unsavoury practices. Honorarium, travel payment, payment for conferences, any expensive gifts or favours should all be listed in an open payment database.

Anoop Misra, Chairman, Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology; Chairman, National Diabetes, Obesity and Cholesterol Foundation (N-DOC); Director, Diabetes and Metabolic Diseases, Diabetes Foundation (India) (DFI)

201411ehm21In India, we already have strong guidelines by MCI. Indian Medical Council (professional conduct, etiquette and ethics) Regulations, 2002, was amended in 2009 and later in 2010 where MCI has suggested various degrees of punishments for doctors who accept gifts worth Rs 1,000 from any pharma or allied healthcare company instead of a total ban including one on research projects. The punishments range from censure (for accepting gifts valued between Rs1,000 and Rs 5,000) to removal from the Indian or State Medical Registry for more than one year (for accepting gifts worth more than Rs 1,00,000).

The only issue is its strict implementation. We in India are not allowed to accept any gift travel etc. from pharma companies, even sponsorship for conference is not permissible. So the only way pharma companies oblige physicians is by enrolling them as researcher/consultant for providing post usage inputs. We already have strong MCI guidelines but as in every country people find ways to manage the law.

Dr Himanshu Bansal, Scientist Spinal Cord Neurodegenerative Disorders & Stem Cell research Mothercell-StemCell Research & Solution, Uttrakhand

201411ehm22Yes, of course there can and there should be transparency around the financial relationships of manufacturers (pharma & device), physicians, and hospitals. After all, this was the norm until a generation ago. This secrecy was introduced in order to hide underhand dealings and has gone completely out of hand. It has spread like a cancer. Sadly, it has become the norm, and distorts the care patients get today. The healthcare system has become sick because of these distorted incentives, and we need to heal the system.

Manufacturers use medical representatives to try to influence doctors to prescribe their products. Sadly, because so many of the products are “me-too” products, they are forced to resort to bribes in order to persuade the doctor to prescribe their brand. Rather than spending money on innovation, the companies find it much easier and more lucrative to bribe doctors for prescriptions. Targets are set for medical representatives, who believe that the only way they can succeed is by giving the doctor whatever he demands.

Companies are extremely smart and they are very clever at disguising these bribes as “educational grants” or “payment for travelling abroad to attend medical conferences.” They manipulate doctors and these payments lead to unethical behaviour on the part of medical professionals.

The ones who are ashamed of the money they receive will refuse to disclose these payments. They know that they are guilty and their conscience pinches them, but they are smart and are able to rationalise their behaviour. A common justification is – “After all, if the senior doctors do it, why shouldn’t I ? I’d be a fool to refuse this easy money.”

Yes, there is scope for a law like the US Physician Payment Sunshine Act (PPSA) in India and because medical corruption is so much more prevalent in India, we should implement a similar measure to encourage honesty. Good doctors will appreciate a law like this.

If a database of payments were created in India what would show that often it’s the most respected doctors – the “KOLs or knowledge opinion leaders” – who are the ones who take the most money from pharma. After all, they have the most clout, which is why pharma wants to pander to them. This list would literally be a “ Who’s Who” of Indian doctors – and would feature many who are extremely influential, and are considered to be the leading lights of the medical profession.

The Indian healthcare system has become sick and openness and transparency can be powerful healing measures. Indian patients deserve a better deal!

Dr Aniruddha Malpani, Medical Director, HELP – Health Education Library for People

201411ehm23We must strive for transparency around the financial relationships of manufacturers (pharma and device), physicians, and hospitals. This alone can bring significant cost reduction to the payers

It is highly unlikely that Indian physicians will be willing to disclose payments they receive from pharmaceutical and device manufacturers? Yes there must be scope for a law like the us physician payment sunshine act (PPSA) in India. Significant transactions of monumental size across India would be revealed if a database of payments were created in India

Dr Alok Roy, Chairman, Medica Group

201411ehm24Yes, I strongly think there can be transparency around any relationship the industry has with the physicians and the hospitals and I would strongly advocate for the same. This would bring the trust of the patients back into the system as other than a few stray cases here and there which bring a lot disrepute to the whole healthcare industry, the primary aim of all the constituents of the industry is the well-being of the patients. Any step that can make it more transparent and fix accountabilities is always welcome and would help in further providing a growth impetus to the industry by giving it the much needed credibility which is getting affected due to a few outliers in the industry.

Samar Khan, Managing Director, Brainlab India

201411ehm25India certainly can work towards implementing transparency protocols around the financial relationships of manufacturers (pharma and device), physicians, and hospitals.

However, currently the cut-practice is so rampant that the protocols can be implemented only through laws, constant monitoring and penalties. It will be a long drawn process.

To begin with, Association of Healthcare Providers (India) is working on a code of ethics which will be promoted as self-regulating code, which will require them to desist from taking any cuts or commission. The practice is so deep rooted that physicians’ willingness or acceptance could be implemented only through law. AHPI is making members conscious of the growing perception among society that the healthcare sector is prone to unethical practices and is urging the industry to take proactive measures against it. There is certainly scope for a law like the US Physician Payment Sunshine Act (PPSA) in India. It is probably the only means to clean up the system.

Dr Girdhar Gyani, Founder Director General Association of Healthcare Providers (India)

201411ehm26Yes, in India there can be transparency around the financial relationships of manufacturers (pharma and device), physicians, and hospitals. This is expected and should be there. However, it all depends on how strictly you enforce the law. The law should not lacks teeth and should not have loopholes and should be legally binding on companies.

There seems to be good paper work with Western organisation since they follow their global policies and try to enforce the same in India. I am not really aware of the practices followed by local manufacturers. But again, since there is a ambiguity in law. It may be hard to measure the effectiveness.

I don’t think there is any system where public can see payments doctors’ receive from manufacturers. There is hardly any transparency. But for an Indian patient to decide on the treatment or doctor based on their ethical behaviour may be a little futuristic at the moment.

Yes. There is scope for a law like the US Physician Payment Sunshine Act (PPSA) in India. If a database of payments were created in India it would reveal payer, receiver and amount and what is the reason for payment at a minimum. There is further need to frame new rules to deal with other corrupt unethical practices like cuts/ commissions to doctors for referring cases.

Kuldeep Tyagi, Global Head of Medical Practice, Cyient

201411ehm27There needs to be transparency around the financial relationships of manufacturers (Pharma & Device), physicians, and hospitals; this can be the only way of ensuring sanctity to the delivery of health. Appropriate direction from regulating bodies can achieve this. Mandated disclosure is the only way to achieve this.

Sponsorship by pharma industry towards achieving improvement in skills, and knowledge of physicians can only help improve patient care, however malpractice can be garbed and misuse of such financing is and will be rampant. Therefore disclosure to regulatory authorities, authorities at work and patients is the best solution.

Stringent measures to ensure that disclosures are complete and unrestricted; powerful punitive action for failed disclosures are obviously a corollary.

Some percentage of Indian physicians would be willing to disclose payments they receive from pharma and device manufacturers, the rest would be unwilling. But that should not be a deciding factor; mandating such disclosures is the need of the hour.

Absolutely, there is a scope for a law like the US Physician Payment Sunshine Act (PPSA) in India. There is a huge opportunity to clean up the system by introducing such laws with due modifications for the Indian context.

If a database of payments were created in India it would differentiate ‘clean’ from ‘unclean’. I can assure you there is a sect of providers and doctors who are clean, however there is equally a group that is not. Exposing the latter is necessary and will only do good to all concerned.

Dr Nandakumar Jairam, Chairman and Group Medical Director, Columbia Asia Hospitals, India

201411ehm28I think that transparency is a credible means to create accountability in healthcare delivery. It has a clear bearing on both prescribing and purchasing habits which in turn impact patient care and safety.

Can we do this in India? Yes. There is nothing that can stop this. Ethical business rules find their place in every ecosystem – provided there is political will for the same. Will they get enforced in the true form is the real question.

Pros: Will make it difficult to break the rules – will not stop until a more holistic multi-pronged approach is adopted.

Cons: It may add to the cost of doing business in India and may lead to more cost being passed on to the customer.

Supplier-provider/ physician interactions follow a similar pattern across the world. But like the traffic on the road, more developed the healthcare ecosystem, it has more rules that make it more organised with lesser tolerance for breaking the rules. Scope for breaking the rules is higher in emerging markets due to possibilities of breaches in accountability in the overall business environment – black money (cash dealings) being a key area to state in this case in India. This is aided by the unorganised channel of small dealers to go to market, who bridge the compliance requirements of the foreign parent (FCPA or the like) and the local realities to serve the needs of customer relationships. Currently, compared to Indian regulators, there is more enforcement in India due to compliance requirements like FCPA (or similar) of the MNCs doing business in India.

Hence, to start, absolute enforcement may be challenging in the Indian context – as a large part of this will either escape reporting or be masked under alternate expense heads. But either ways, it will be a welcoming step. Counter controls can be set-up by strengthening the healthcare supply chain to correlate patronage of drugs and devices with possible financial relationships between suppliers and providers.

Vineet Kapoor, MD, Inhx Indian Healthcare Exchange

201411ehm29Financial transparency would definitely be a good option for India and would help in ethical and compliant functioning and relations between manufacturers (pharma and device), physicians, and hospitals. However, we do not see such mature relationship amongst the stakeholders in the current scenario and as with most other industries it may not happen in the very near future.

The pharma and device manufacturers are in a very competitive sector and are sales/ revenue driven organisations. In their quests to ensure top/bottom lines, many a times due to pressure the companies or employees acting independently may have turned to gift distribution/ cheque distribution to put it very mildly. On the other hand poor pay/ income and no proper standardisation of the healthcare practitioners/ sector in the country may have driven the physicians to accept/ demand such relationships. Minimal or no regulations regarding such relationships may be another contributing factor.

I am not sure if Indian physicians will come out clean to disclose all payments received directly or indirectly.

Proper regulations and standardisation will be required before implementation of such laws (like the US Physician Payment Sunshine Act) in the Indian setting. Also proper implementation and ensuring control to prevent misuse of the law need to be in place.

If a database of payments were created in India it would it reveal a Pandora’s box and better left at that. For creation of such a database we need to ensure proper legislation and ensure bringing physicians, physician associations, pharma/ device industry, hospitals and healthcare institutions, insurers/ TPAs/ Payors under one department/ ministry. Currently each of them function under different structures which gives rise to ambiguity of regulations which may be one of many loopholes to the functioning of physician-industry interactions.

Current tightening of certain regulations/ guidances – e.g. clinical trial participation, video recording of consent, MCI guidance on accepting gifts, foreign travel by physicians, OPPI guidance etc., may have been deterrents but these need to be consolidated.

Dr Karen Marlyn Syiem, Principal Consultant, Integra Ventures, Guwahati

201411ehm30Yes there can be transparency around the financial relationships of manufacturers (Pharma & Device), physicians, and hospitals in India. Typically pharma and device manufacturers interact with physicians through sponsorship of educational activities and CME programmes.

I can’t really speak for all physicians. Presumably if there was a law requiring discloser of payments then Indian physicians would be willing to disclose payments they receive from pharmaceutical and device manufacturers.

There is always a scope for regulation, however what ultimately matters is how the regulation is enforced.

Dr Arjun Kalyanpur, CEO, Teleradiology Solutions

201411ehm31In India can there be transparency around the financial relationships of manufacturers (Pharma and Device), physicians, and hospitals? My answer is a big ‘Yes”, as every human being like the quality of being honest, and keep good qualities of having good integrity and character. Like corruption, it is a social evil and doctors are no exception and perhaps there are more temptation or opportunity for those have an extra need or greed. Good civic sense and education and social obligation will make any citizen to follow ethical practices and surely a majority of Indian physicians can follow the same. Presently, I do agree lot of trade practices are happening in India which are considered as normal but ethically wrong and can fall within the definition of corrupt practices. It is not just the responsibility of pharma companies or medical device manufactures to correct and clean the system. If everyone work towards ethical and non corrupt practices it is achievable just like removing corruption from politics. Today the way of interaction involves lot of trade fares, marketing visits, free samples, incentives, travel facilities, sponsorships etc. which are considered part of promotional activates and many times no one defines it as unethical.

I am sure only a small section of people accept unethical norms and they can be brought back to the main stream and government can make strict guidelines for ethical trade practices and value based medical business.

I think eventually we need to make a law very similar to what US is doing and it will slowly but surely pick up momentum. Common man wants a system corrupt free and ethical dealings and any civil society will eventually accept it as the best form to have an equal justice honest system.

If a database of payments were created in India. It can be the same effect like Income Tax Department reveals the names or deals which requires explanation or legal action but revealing such information do not generalise a system or point out everyone is part of such unethical system.

Som Panicker, VP, MRI Division, Sanrad Medical Systems

201411ehm32Can there be transparency around the financial relationships of manufacturers (pharma & device), physicians, and hospitals? Why not, provided there is a strict law in this regard that is enforced as well. Recently MCI has tried to bring in regulations that restrict such financial transactions between vendors and HCPs, but then they don’t have the mechanism to check and enforce the same unless they receive specific complaints with adequate proofs.

It is difficult to generalise how pharma and device manufacturers interact with physicians, as many companies follow stringent ethical norms while there are others who compromise and offer incentives to the HCPs as quid pro quo for favourable recommendations/ purchase decisions.

Very much doubt that Indian physicians would be willing to disclose, but if there is strict regulations then suppliers can be mandated to disclose. Problem is most of these transactions happen in cash, hence difficult to trace.

There is not only scope for a law like the US Physician Payment Sunshine Act (PPSA) in India, but dire need to have one if we have to weed out corruption from the healthcare space. It should however not be limited to interactions between vendors and HCPs but also extended to interactions between say HCPs and diagnostic centres or clinics/ nursing homes/ hospitals etc. There is lot of internal referral that goes on within the HCP community which also hikes patient charges.

It is impossible to create a database given mostly these are cash payments or benefits passed on in terms of free international trips etc. But one thing is sure, if this malpractice is curtailed it can bring down the price of drugs, medical devices and patient diagnostics and treatment costs.

Ashok K Kakkar, Senior MD, Varian Medical Systems International India

201411ehm33There can be transpare ncy around the financial relationship of manufactures of pharma and devices, physicians and hospitals. The pharma and the device manufactures interact with the physician through their representatives directly. The physicians in India should be willing to disclose payments they receive from pharma and device manufactures as per the ethics. There is scope for a law like the US physician payment sunshine act in India suitable to Indian condition. The database of payments will reveal the nature and extent of financial relationship among all the three stake holders (manufactures of pharma and devices, physicians and hospitals), waste full healthcare spending and inappropriate influence on research, education and clinical decision making. There should be an appropriate frame work to include all the payments made directly to physicians and teaching hospitals, also the payments made indirectly to the physicians and teaching hospitals and payments made to third party by designated physicians or teaching hospitals. This will provide financial probity, transparency and all round growth of the health sector and will make the healthcare affordable and serve healthcare needs of the suffering mankind.

Dr Purshotam Lal, Chairman and Director, Interventional Cardiology, Metro Group of Hospitals

201411ehm34Yes there can be transparency around the financial relationships of manufacturers (pharma & device), physicians, and hospitals but very difficult under these circumstances. There is no legislation in our country and hence no transparency.

If the Government has the will, there is scope for a law like the US Physician Payment Sunshine Act (PPSA) in India. If a database of payments were created in India, firstly there needs to be a statute that the disclosure is compulsory like IT return. Then it would be very effective. But till then it’s wishful thinking.

Dr Sujit Chatterjee, CEO, Dr L H Hiranandani Hospital

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