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MCI has been dissolved but the guidelines to doctors must remain, carefully sanitizing the ambiguities within the process

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The recent developments within the MCI are indeed very disturbing and were definitely avoidable, if appropriate checks and balances were in place within the system. Even after the immediate ‘damage control measures’ by the Government, I reckon, the stigma on the credibility of MCI, may continue to haunt the institution, for a reasonably long time. The steps taken by the government, so far, are definitely necessary.

The new board appointed by the Ministry of Health, we expect, will work out an appropriate policy framework not only to restore the credibility of MCI, but also to put in place enough measures to prevent repetition of blatant misuse of power by the vested interests, in future.

The other side of it:

In today’s India, blatant commercialization of the noble healthcare services has reached its nadir, as it were, sacrificing the ethics and etiquettes both in medical and pharmaceutical marketing practices at the altar of unlimited greed. As a result of fast degradation of ethical standards and most of the noble values supposed to be deeply rooted in the healthcare space, the patients in general are losing faith and trust both on the medical profession and the pharmaceutical industry, by and large. Health related multifaceted compulsions do not allow them, either to avoid such a situation or even raise a strong voice of protest.

Growing discontentment – a stark reality:

Growing discontentment of the patients in the critical area of both private and public healthcare in the country, is being regularly and very rightly highlighted by the media to encourage or rather pressurize all concerned to arrest this moral and ethical decay and reverse the evil trend, without further delay, with some tangible regulatory measures.

It was a laudable move by the MCI, the current fiasco not withstanding:

In such a prevailing situation, recent steps taken by the ‘Medical Council of India (MCI)’ deserves kudos from all corners. It is now up to the medical profession to properly abide by the new regulations on their professional conduct, etiquette and ethics. The pharmaceutical industry of India should also be a party towards conformance of such regulations, may be albeit indirectly.

No room for ambiguity:

The amended MCI regulations, no doubt, are aimed at improving the ethical standards in the medical profession and are expected to achieve the desired objectives. However, in many places the guidelines lack absolute clarity.

Ambiguity, if any, in the MCI regulations, should be addressed through appropriate amendments, in case such action is considered necessary by the experts group and the Ministry of Health. Till then all concerned must ensure its strict compliance… for patients’ sake. The amended MCI regulations are only for the doctors and their professional bodies. Thus it is up to the practicing doctors to religiously follow these regulations without forgetting the ‘Hippocrates oath’ that they had taken while accepting their professional degree to serve the ailing patients.

If these regulations are implemented properly, the medical profession, I reckon, could win back their past glory and the trust of the patients, as their will be much lesser possibility for the patients to get financially squeezed by some unscrupulous elements in this predominantly noble profession.

A concern:

Although the new MCI regulations are steps in the right direction, the pharmaceutical industry, by and large, does have an apprehension that very important and informative ‘continuing medical education (CME)’, which in turn could help the patients immensely, may get adversely impacted with this new regulation; so are the areas involving medical/clinical research and trials.

What is happening in the global pharmaceutical industry?

Just like in India, a public debate has started since quite some time in the US, as well, on allegedly huge sum of money being paid by the pharmaceutical companies to the physicians on various items including free drug samples, professional advice, speaking in seminars, reimbursement of their traveling and entertainment expenses etc. All these, many believe, are done to adversely influence their rational prescription decisions for the patients.

USA:

In the USA ‘The Pharmaceutical Research and Manufacturers of America (PhRMA)’ has recently revised their code of marketing practices as follows:

• “Prohibits distribution of non-educational items (such as pens, mugs and other “reminder” objects typically adorned with a company or product logo) to healthcare providers and their staff. The Code acknowledges that such items, even though of minimal value, “may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues.”

• Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits to healthcare professionals.

• Includes new provisions that require companies to ensure that their representatives are sufficiently trained about applicable laws, regulations and industry codes of practice – including this Code – that govern interactions with healthcare professionals. Companies are also asked to assess their representatives periodically and to take appropriate action if they fail to comply with relevant standards of conduct.

• Provides that each company will state its intentions to abide by the Code and that company CEOs and Compliance Officers will certify each year that they have processes in place to comply, a process patterned after the concept of Sarbanes-Oxley compliance mechanisms. Companies also are encouraged to get external verification periodically that they have processes in place to foster compliance with the Code. PhRMA will post on its Web site a list of all companies that announce their pledge to follow the Code, contact information for company compliance officers, and information about the companies’ annual certifications of compliance.

• Other additions to the Code include more detailed standards regarding the independence of continuing medical education (CME); principles on the responsible use of non-patient identified prescriber data; and additional guidance for speaking and consulting arrangements with healthcare professionals, including disclosure requirements for healthcare providers who are members of committees that set formularies or develop clinical practice guidelines and who also serve as speakers or consultants for a pharmaceutical company.

• Other changes to the Code include, PhRMA’s recent acceptance of the revised Physician Payments Sunshine Act in the Senate.”

Raging ongoing debate on the financial relationship between industry and the medical profession:

As the financial relationship between the pharmaceutical companies and the physicians are getting increasingly dragged into the public debate, it appears that there is a good possibility of making disclosure of all such payments made to the physicians by the pharmaceutical companies’, like the proposed Physician Payments Sunshine Act in the USA, mandatory in many other countries, probably even in India.

Exemplary voluntary measures taken by large global pharmaceutical majors:

Eli Lilly, the first pharmaceutical company to announce such disclosure voluntarily around September 2008, has already uploaded its physician payment details on its website. US pharmaceutical major Merck has also followed suit and so are Pfizer and GSK. However, the effective date of their first disclosure details is not yet known.

Meanwhile, Cleveland Clinic and the medical school of the University of Pennsylvania, US are also in the process of disclosing details of payments made by the Pharmaceutical companies to their research personnel and the physicians. Similarly in the U.K the Royal College of Physicians has been recently reported to have called for a ban on gifts to the physicians and support to medical training, by the pharmaceutical companies. Very recently the states like Minnesota, New York and New Jersey in the US disclosed their intent to bring in somewhat MCI like regulations for the practicing physicians of those states.

Transparency is the key for drug industry relationships – Australia sets another example:

The Australian Competition and Consumer Commission (ACCC) has decided to grant authorization for five years to Medicines Australia’s 16th edition of its Code of Conduct. The Code sets standards for the marketing and promotion of prescription pharmaceutical products in Australia.

The Code provides, among other things, a standard to address potential conflicts of interest from unrestricted relationships between pharmaceutical companies and healthcare professionals, which may harm consumers, for example through inappropriate prescribing by healthcare professionals.

The Code prohibits pharmaceutical companies from providing entertainment and extravagant hospitality to healthcare professionals, with the requirement that all benefits provided by companies successfully withstand public and professional scrutiny.

“The requirement for public disclosure was imposed by the ACCC as a condition of authorization of the previous version of Medicines Australia’s Code and was confirmed on appeal by the Australian Competition Tribunal.” Edition 16 of the Code fully incorporates the public reporting requirements.

Conclusion:

Currently in the US, both in Senate and the House of Congress two draft bills on ‘The Physician Payment Sunshine Act’ are pending. It appears quite likely that Obama Administration, with the help of this new law, will make the disclosure of payments to physicians by the pharmaceutical companies mandatory.

If President Obama’s administration takes such regulatory steps, will India prefer to remain much behind? The new amended MCI regulations together with such disclosure by the pharmaceutical companies, if and when it comes, could make the financial transactional relationship between the physicians and the pharmaceutical industry squeaky clean and totally transparent.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Increasing socio-economic inequality within the healthcare delivery systems of India

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Increasing inequality between the wide diversity of population of ‘haves’ and ‘have-nots’ in the socio-economic and cultural set up of India, clearly gets reflected in the healthcare delivery system of the country. Many research studies on this subject have established a clear relationship between healthcare services and socio-economic inequality. Several lakh of Indians still perish in the country because of this reason.
Economic growth needs to be inclusive – better said than done:
Initiation of financial reform measures since 1990 and the process of globalization during this period have spurred the economic growth of the country, the rate of which comes just next to China in the global scale of comparison for the same. However, many people strongly believe that this reform process has not been as inclusive as it should have been. Otherwise why will the country continue to witness worrisome instances of abject poverty within a large section of the society with an abnormally high rate of mortality?

Healthcare sector in India – huge socio-economic inequality:

According to the Investment Commission of India, the healthcare sector of the country has experienced rapid growth of around 12% since last 4 years and is expected to be of U.S. $ 280 billion industry by 2022.

However, due to socio-economic inequality, this growth has not been evenly distributed. As a result, 65% of the population of India still do not have access to modern medicines and a vast majority of the population experience poor healthcare facilities. Around 10 lakh women and children die in India either due to poor access to healthcare services or they cannot afford the healthcare expenses.

Centers of excellence – but not for all:

In the healthcare sector, despite having many centers of excellence of global standards, which are also attracting ‘medical tourists‘ from across the world, healthcare needs of a large number of population of the country are not being addressed adequately. About 700 million of population have no access to specialists’ care even today. The Government of India alone will not be able to address this problem of gigantic proportion without workable and time-bound Public Private Partnership (PPP) initiatives with an investment of over U.S $ 20 billion at least for next five years. For example, in terms of availability of hospital beds per 1000 population, India stands at 0.7 against 3.96 of world average.

“Fortune at the bottom of the pyramid” – anybody follows in India?

Professor C. K. Prahalad’s famous dictum, “Fortune at the bottom of the pyramid” has not been realised yet by many within the global healthcare industry, perhaps with the solitary exception of Andrew Witty, the young CEO of GlaxoSmithKline.

As per data available from the Government publications, the bottom of the pyramid where a large proportion of the Indian population is located, reflects a huge socio-economic inequality even in the healthcare sector as follows:

• Overall spending on healthcare in India is around 6% of GDP (Public and Private sectors put together). However the public expenditure is only 0.9% of the total spending.

• In rural areas per capita expenditure on healthcare is seven times lower than urban areas.

• In rural areas the ratio of hospital beds to population is fifteen times lower than the urban areas.

• In rural areas the ratio of doctors to population is almost six times lower than the urban areas.

• The rate of Infant Mortality in the 20% of the poorest population is 2.5 times higher than the richest 20% of the population in rural areas.

• Despite more health issues an individual from the poorest quintile of the population is six times less likely to access hospitalization than a person from the richest quintile in rural areas.

• From the poorest quintile of the population, the child delivery of a mother is over six times less likely to be attended by a medically trained person than during child delivery of a mother from the richest quintile of the population in rural areas.

• On an average 78% healthcare expenditure in India comes as ‘out of pocket payments’ by the people, whereas only 18% of the same is borne by the state followed by 4% by medical insurance.

• Towards public healthcare spending, only five other countries in the world (Pakistan, Burundi, Myanmar, Cambodia and Sudan) are worse off than India.

• Only 38% of all Public Health Centres (PHCs) have essential manpower and only 31% have the essential supplies with only 3% of PHCs having 80% of all critical inputs.

As a result of inadequate and unequal spending on the healthcare infrastructure, healthcare systems, healthcare financing and healthcare delivery, both by the public and private sectors in the rural areas, such inequalities towards access and affordability of the healthcare services,especially in rural India where over 70% of the country’s population reside, have now assumed an alarming proportion .

Access to healthcare is fundamental in many countries of the world:

Most of the developed countries of the world extend comprehensive healthcare access to its citizens. Even our close neighbour Thailand and Fidel Castro’s land, Cuba along with many other developing countries of the world extend basic healthcare facilities to all their citizens.

Urban poor also face the harsh reality of healthcare affordability issue:

Survey results indicate the following facts so far as urban poor are concerned:

• Healthcare facilities though skewed towards urban India, the healthcare cost, lack of culturally appropriate services; social prejudices etc prevent access to healthcare even to the urban poor.

• Infant and under-five mortality rates in the urban slums for the poorest 40% are as high as is prevalent in the rural areas.

• Because of mainly poverty, poor hygienic and almost non-existent sanitation conditions, urban slums have now become the breeding ground for diseases like cholera, malaria, hepatitis, tuberculosis, HIV – AIDS and a large variety of infectious disease.

All these conditions coupled with almost total lack of health education in slums further aggravate the healthcare situation.

Has the National Health Policy delivered?

It is widely believed that Infant and Maternal Mortality rates of a country are the most important indicators of the health of any society. For the year 2000 The National Health Policy of India had set a target to bring down the Maternal Mortality Rate to below 200 per 1 lakh live births. However, even today around 407 mothers die every year due to pregnancy related complications. So far as infant mortality is concerned the figure remain as high as 22 lakh every year.

A very sad state of public healthcare delivery system gets reflected through these very basic numbers, despite various government initiatives and mushrooming private and corporate investments towards healthcare. The privileged class of the society, as a result, is getting better and better private healthcare services and the under-privileged class is denied of, in many cases, even the very basic healthcare facilities. All these bring out to the open the social and economic inequality in our civil society even for the very basic healthcare needs of its citizens.

Growth of Private Healthcare initiatives is welcome, but are they maintaining an urban-rural balance?

Urban centric private healthcare sector in India is growing at a faster pace. However, overwhelming dominance of this sector in absence of robust PPPs will further increase the urban bias with focus on higher profit margin being more important than offering primary and secondary healthcare services to a large number of the deprived population with lesser profit margin. Following published facts may help understand the prevailing situation:

• The increasing cost of healthcare paid predominantly through ‘out of pocket’ is making healthcare unaffordable to a large number of the population.

• The number of people who are unable to seek healthcare services due to affordability issue is growing, despite rapid economic growth of the country.

• The number of people who cannot afford to basic healthcare services has doubled compared to just a decade ago.

• One in three people who need hospitalization and paying ‘out of pocket’ are forced to borrow money or sell assets to cover healthcare expenses.

• Because of ‘out of pocket’ spending on healthcare, over 20 million Indians are pushed below the poverty line every year.

• A World Bank report acknowledges the facts that doctors recommend unnecessary investigations and over-prescribe drugs in private healthcare sector.

• The same report acknowledges the relationship between the quality and cost of healthcare services in the private healthcare system with high priced services being excellent but unaffordable to many.

Conclusion:

All these facts will further establish the prevalent socio-economic inequality within the healthcare delivery systems of India. Rapidly growing urban centric private healthcare initiatives are welcome but these are now just catering to the privileged few, keeping the pressing healthcare issues of India unanswered. Only well planned time-bound PPP initiatives, in my view, are capable to address the humongous healthcare issues of India.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Key business strategies of global pharmaceutical industry are undergoing a radical change, while in India we are still thinking within the box. Who cares about the global clue?

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One of the leading consulting companies, PricewaterhouseCoopers (PwC) in its report of June 2007 titled “Pharma 2020: The vision –Which path will you take?” postulated that the business model followed by the global pharmaceutical companies is, “economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments demanded by global markets”.
R&D is failing to deliver:Datamonitor highlighted that drugs worth U.S$ 140 billion will go off patent by 2016. Thus the value turnover that will be lost because of number of drugs going off-patent will be almost impossible to replace by this time. Many analysts have been expressing concerns about gradual but steady decline in pharmaceutical R&D productivity since quite some time. During this period, most of the research based companies could afford only a small increase in their R&D budget, while marketing and other overhead expenditures registered a significant increase.

Single global process of Drug Regulatory approval…is possible…but is it probable?

PwC in the same report touched upon another interesting possibility within the R&D space of the global pharmaceutical industry. It indicated that the research based pharmaceutical companies will gradually switch over from, “Classic model of drug development that ends in regulatory approval to ‘live licenses’ that allow for narrow product launches followed by gradually expanding approvals as drugs are continuously tested.”

Most interestingly, the report also forecasted that by 2020, the drug regulators across the world will work together under a collaborative framework to arrive at uniform and single global process of drug regulatory approval. If it materializes, the process will indeed be path breaking in every sense.

Global pharmaceutical market will register significant growth:

Following this trend, the report highlighted, that the global pharmaceutical sales will touch U.S$ 1.3 trillion by 2020, almost double of what it is today. High growth of emerging markets and the aging global population are expected to be the key growth drivers.

During this period E7 countries like, Brazil, Russia, India, China, Mexico, Turkey and Indonesia are expected to contribute around 20% of Global Pharmaceutical turnover. Keeping pace with the economic progress, the disease pattern of these countries are also changing, from infectious diseases to non-infectious chronic illnesses, like diabetes, hypertension, just as we now observe in the developed world.

Together with this change, many predict that ‘greenhouse effect’ arising out of global warming process will have significant impact on health of the global population, resulting in large scale re-emergence of diseases like malaria and cholera together with various types of respiratory disorders.

Radical change is envisaged in pharmaceuticals marketing:

In April 2009, PwC came out with another interesting report titled, “Pharma 2020: Challenging business models, which path will you take?” on the future of the global pharmaceutical industry.

As the time progresses global pharmaceutical companies will need to understand the shift in ‘perceived value’ that is taking place within patients, medical profession and the community as a whole towards healthcare delivery. Just an innovative medicine will no longer be able to satisfy their ‘value expectations’. Pharmaceutical companies will have to offer a ‘bundle of benefits’, combining the innovative products with related health services, for which the market will not hesitate to pay a reasonable premium.

Thus in future, global pharmaceutical companies will need to collaborate with disease management specialists for a “holistic offering” to address an ailment rather than just treatment of the disease with medicines. Such “value added and innovative” marketing strategies will differentiate business success from failure, in 2020.

In the recent report PwC advocates that to be successful, in future, global pharmaceutical companies will need to change their ball game almost radically. The future strategy will focus on collaborative arrangements between various allied healthcare establishments and the pharmaceutical companies to offer a “holistic solution” to the patients in all disease areas.

That means, global manufacturer of an anti-diabetic drug will need to offer along with the innovative drug, counseling on diet regimen, suggesting exercise programs and their follow-up, reminders for regular and timely intake of medicines and many more. Who knows?

“Better late than never”:

In any case, to excel in business at a time when the global pharmaceutical business model is undergoing a fundamental shift; there is a need to keep on investing more towards R&D, which will continue to remain the ultimate growth engine of pharmaceutical business, the world over. At the same time, there will be a dire need to prune expenditure in innovative ways and that opens the door for global outsourcing of various business processes from most cost efficient countries having world class facilities.

Domestic pharmaceutical players, if start mustering all resources to avail these global opportunities, India can soon become a global hub for pharmaceuticals outsourcing, outracing China which is currently placed ahead of India, in this field. As the good old saying goes, I shall always wish, “better late than never”.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.