Clairvoyance 2013… a vision within and beyond

The two-day annual health event of the School of Health Systems Studies (SHSS) at TISS last week, renewed its commitment towards health care in India. With a theme of Re-imagining health and health care in India, the event brought together the who’s who of the field under one roof. Although the event was an amalgamation of both the private and public health aspects, as a public health professional I will present some of the public health issues that were highlighted in the weekend.

Clairvoyance was inaugurated by the country coordinator of UNAIDS, Mr. Ousamma Tawil. His inaugural speech addressed the audience with a question: was HIV (Human Immunodeficiency Virus) a problem in India? Yes. Was it being addressed? Yes, too. Were all people living with HIV being reached? Was money spent well? Umm… As he mildly put in the known fact that India may soon be the country with the largest population in the world, he emphasized that number (of HIV patients) was big. With 2.1 million people living with HIV, India has an annual incidence of 130,000. The key population is 8 percent trans-genders and 7 percent intravenous drug users among others. The way forward in primary health had to be based on AIDS prevention. So what seems to be an obstacle for India? With Men Seeking Men and Female Sex Workers being criminalized prevention in the key population and then in the general population is restricted. As though his address was some sort of prediction, last week’s High Court judgment on the criminalization of gay sex pins down the cultural behavior of the society of India towards this section. This attitude, Mr. Tawil said, will prevent the bridges that are required to bring people out of the dark and into the functionalities of social programs. Plans of inclusion and scaling up must be made.

With the number of people treated for HIV as 700,000 in 1700 centers across the country focusing on HIV treatment, India is the second largest nation after South Africa in the treatment of HIV/AIDS. Another milestone for India is its position as the generic pharmaceutical capital where it produces more than eighty percent of the anti-retro virals (ARVs) supplied to the world. With a reduction in external funding, the National Aids Control Organization (NACO) continues to support the momentum required to sustain the activities and has shown a drop of 57 percent in the incidence of HIV infection in the country. So why do issues like discrimination, stock outs and protests regarding these have to be in the way?

In continuum with a focus on the role of social determinants of health, Dr. Anurag Bhargav, Associate Professor at Himalayan Institute of Medical Sciences, brought to light a rather neglected aspect in the management of Tuberculosis (TB). Taking us back into the past when India was still ‘virgin’ soil for TB, Dr. Bhargav showed us the pathway in which TB soon had not only invaded the country but had become one of the top reasons of morbidity and mortality. The British who then occupied India and also suffered from TB, soon recovered while Indians continued to succumb to the disease and the only difference in management was pointed out to be Nutrition – the British were well nourished. He reminded us that it was Rene J. Dubos who in the early twentieth century had stated that, “TB is a social disease” (The White Plague). This condition of under-nutrition is still ignored and the Anti-tubercular pills, whether for six or twenty-four months, will be of little use if not supplemented with nutritious food for all patients who struggle to fight the disease. The only vaccine, Dr. Bhargav remarked, to fight TB is FOOD.

In the session on innovations in public health, various kinds of innovations especially those involving the community were presented. These included training and community health clinics where the community themselves were involved in the services provided, community auto rickshaws being used as emergency transport to health care and means of social marketing of condoms. Dr. Sapna Surendran, a Research Associate from Models Districts Health Project, Columbia Global Centers, gave the audience an idea of what it takes for an innovation to be expected on national level. Initial steps range from baseline studies and analysis of existing national surveys to triangulating this information with government officials and local stakeholders. Designed interventions are implemented and soon presented to the state and central level government that then considers whether this innovation can be applied at the local level. While all is not rosy during the process of approval, the implementation of the approved innovations at large scale also poses challenges.

As thought provoking topics were discussed extensively and ideas challenged, Ms. Leena Menghaney, India Coordinator, Campaign for Access to Essential Medicines, Medecins sans Frontieres (MSF) introduced to the audience the need for advocating for cheaper drugs. With extensive efforts MSF has been able to bring down the market price of a HIV drug from US$ 10,000 per patient per year (ppy) to just under US$100 ppy. The crunch of the issue lies in the fact that if pharmaceutical companies continue to have their way, applying for patency in every incremental change in the drug molecule, causing a monopolization in the market with the ever-greening of the drug. In that scenario, even large organisations like MSF will not be able to afford drugs for all those who require it in their projects around the world. This simply stands in no comparison then to the plight of the individual who will have no choice but to give up. While we may say HIV will not affect me, this concept is true for drugs used for management of cancers, hepatitis and many other common diseases that challenge public health today.

From an appeal of change in behavior towards those marginalized in HIV, to a call to simply feed those with TB. From the need of bringing creativity into community health programs to advocating for affordable drugs worldwide. Such were the issues that stirred up the group of budding health professionals at TISS last weekend.

By- Dr. Carolyn Kavita Tauro

MPH-Social Epidemiology

2012-2014 Batch

TISS, Mumbai

A Critical Insight into India’s New Drug Pricing Policy

Healthcare costs in India are escalating every day becoming unaffordable for the common man. It was found that drugs contribute to 70% of the out of pocket expenditure for healthcare in India. Several factors contribute to the escalating costs of the drugs absence of proper price regulation in the country being the greatest of all. This leads to inaccessibility of medicine by the common man. Though some states like Tamil Nadu, Kerala and Rajasthan have a proper drug procurement system in place to provide low cost medicines to people, majority still rely on the private pharmacies where the prices are not affordable. Hence, there is an urgent need to control the drug prices in the market to enhance accessibility.

Previous pricing policy – Cost Based Pricing

According to cost based pricing policy (CBP) the ceiling price of a drug was fixed based on the cost of production i.e. cost of raw materials plus cost of conversion plus the maximum allowable post manufacturing expenses (MAPE) of 100% which also includes the profit of manufacturer and various distribution costs. There were some difficulties faced under CBP which could have been avoided by prompt revision of the ceiling prices of bulk drugs.

Present pricing policy – Market Based Pricing

After several hurdles, government of India notified  the new National Pharmaceutical Pricing policy (NPPP) 2012 which is based on the concept of market based pricing. The main objective of the policy as stated in the gazette released is “….to put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines – “essential medicines” – at reasonable prices even while providing sufficient opportunity for innovation and competition to support the growth of industry, there by meeting the goals of employment and shred economic well-being for all.”

According to this, ceiling price of a drug would be determined by adopting the simple average price of all the brands having market share (on the basis of moving annual turnover) more than and equal to 1% of the total market of that medicine. Now the manufacturers would be free to fix any price below or equal to the ceiling price. This claims to reduce the prices of drugs and make the medicines available and affordable which may not be true in the practical sense.

First of all this policy could not give a proper justification for abandoning cost based pricing when retail prices of consumer goods and services are fixed on the cost of production. Policy justifies itself by saying it is very tedious process to collect data from the manufacturers and to calculate ceiling price every year on the basis of CBP. A simple and transparent mechanism can be put in place for collecting prices of bulk drug/Active Pharmaceutical Ingredient (API) from the excise department where manufacturers file their excise duty returns without resulting in any manipulations from the manufacturers.

The policy forgets to take into consideration other factors influencing the price of drugs. The unethical and illegal promotional/marketing activities are resulting in the bulging costs of the most of the drugs. The amount spent by the company on these marketing practices is borne by the consumer purchasing the medicine and making it unaffordable. Hence, there should be a proper mechanism in place to curb these unethical practices to control the cost of the drugs.

Reliability on the data collected to calculate ceiling price

In the paragraph 4 (ix) of the policy document it is said that “The ceiling price of the drug listed in the National list of essential medicines (NLEM) would be the simple average of prices as calculated on the basis of IMS data…”. To calculate ceiling price, data on the market share by brand, volume and price of the brand is required which is generated by IMS Health (a provider of information related to pharma industry) a private company which cannot be reliable. Policy also does not have any measures to check the robustness and reliability of the data generated by a private information provider. Moreover the data is not accessible in the public domain. So, how a public policy can be made by the data which is neither reliable nor accessible in the public domain. WHO also warned India over the method of obtaining drug pricing data from IMS Health. Previously, ORG-MARG (merged into IMS Health) study on “Trends in the price index of pharmaceutical formulations” was also questioned. It was also said that IMS pricing data is not reliable as it does not take account of discounts and rebates.

Moreover, in India drugs with the biggest volume of sales are often the highest priced ones. In such a situation calculating ceiling price on MBP will only result in increase in the price of the drugs and increase the profits of manufacturers making essential medicines unaffordable.

Inclusion of the drugs

There are more than 800 molecules that are being used in India. But, the policy takes into consideration 348 drugs that are listed in NLEM and leaves the rest of the medicines outside the list. Doctors influenced by the incentives given by drug manufactures also prescribe medicines which are not in the NLEM and not under price control. As there are no regulation on prescribing pattern there need to be a study done on the prescribing pattern and include those drugs which are highly prescribed. For example, salbutamol used in the treatment of bronchial asthma falls into the category. But, there are many other drugs of the same therapeutic category which are being prescribed to treat asthma are not brought into the price control.

In case of non-price controlled drugs, policy states to fix the price of such drugs in case if they increase by more than 10% in a year. Hence, it is evident that it allows the increase of price up to 10% annually. Policy also failed to provide a mechanism by which it will control the price of non-price controlled drugs.

Price control of Fixed Dose Combinations

Now-a-days one can find most of the drugs available in the market are fixed dose combination (FDCs). A doctor’s prescription also reveals the extent of usage of the FDCs by the consumer. Though very few FDCs like iron and folic acid, vitamin D and calcium are brought under price control most of the FDCs are left to the free market. There are also many irrational FDCs available in the market and which are being prescribed.

In paragraph 4 (xvii) of the policy document it is said that “…… If a manufacturer of a NLEM drug with dosages and strengths as specific in NLEM, launches a new drug by combining the NLEM drug or non NLEM drug or by changing the strength and dosages of the same NLEM drug, such manufacturers shall be required to seek price approval from the government before launching the new drug.” But, we do not know how the government is going to ensure the control and under what mechanism it will control the price of such FDCs coming into the market. Hence, there should be a strict regulation on allowing FDCs into the market to control irrational combinations and a proper mechanism should be in place to fix the price of new FDCs.

To conclude a better policy can be framed considering the loop holes of the present policy which is a market based one. When implementing a policy of huge public concern data should be collected from reliable sources. Prescription patterns should be understood to include various other formulations which are not currently under price control. There should be a mechanism in place to curb unethical marketing practices and allowing irrational FDCs to enter the market which increase the cost of medicine making it unaffordable. Hence, in a country like India where most of the healthcare expenditure is out of pocket 70% of which accounts for medicines, there should be a proper mechanism to control the price of drugs to make health care affordable.

By- Pavan Kumar Allani

MHA-Health Administration

2012-2014 Batch

TISS, Mumbai

Mental Health Act, 2013: a mockery of Human Rights

Legislations are formulated to protect and promote the interest of the individual and society. But sometimes these laws turn against the human beings and breach their fundamental rights. Such laws are based on utilitarian principle i.e. they focus on the interest of a large population at the expense of minors. So it is not necessary that if something is legal, it is also ethical. Mental Health act of our country is the illustration of such an unethical law.

                     People suffering from mental illness bears double burden of their illness and stigma associated with their illness. The pervasive impact of their illness echoes in every facet of their life whether it social, professional or economic. They are even abandoned by their family members. They face isolation and helplessness in their everyday life. The society remains ignorant to their needs. Their life is not less than virtual hell in the community. Their abysmal condition requires a legal framework to safeguard their interest. Ironically these mental health acts are violating the human rights of such people rather than protecting them. A predicament exists when we consider the mental health act in light of human rights. Traditionally, the purpose of any such law is to isolate the individual from the rest of society as they are considered as troublesome and dangerous for society.     

                           In India the first mental health act was formulated in 1858 through Indian lunacy act. Under this act, mental asylums were set up and mentally ill people were called as idiots, insane or lunatics. This Act was amended in 1912 and civil surgeons were put in charge of the mental hospitals instead of the Inspector General of Prisons. In 1987, mental health act was passed by Indian Parliament. This act has been criticized due to its main emphasis on promoting the institutionalization of mental health care and it also fails at its implementation level. Its implementation problem revealed after a fire accident in an asylum in Tamil Nadu in 2001.In this accident 28 people with mental illnesses were died because they were unable to run as their legs were tied to stone pillars. In 2007, India became signatory to the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD). India under compulsion has to bring its existing laws into congruence with the basic principles of the UNCRPD.

                      As a result, India initiated the process of amending the mental health act, 1987. These amendments could have been a hope for people living with mental illness but unfortunately the new proposed mental health care bill, 2013 continues to approach a mentally ill person through his illness and not through his rights.

Now I will look critically at the proposed amendments in the mental health act from an ethical perspective.

1. The whole process of amendments was non-participatory and unfair. Neither the people suffering from mental illness have been informed nor has their voice been included in drafting a law that will determine their lives. Even the Nodal Ministry for the affairs of disabled persons and the Ministry of Social Justice and Empowerment were not consulted before formulating amendments.

2. The proposed definition of mental illness excludes the mental retardation. It puts an open ban on the treatment of all mentally retarded persons in psychiatric hospitals. Mentally retarded individuals require need care in total care institutions where a mental health care professional expertise is available.

3. The amendments overlook the individual’s right of autonomy. Any person who is 18 years of age or above and is competent can appoint a person known as “nominated representative (NR)”. The representative should be above 18 years of age. He/she helps the patient to interact with the mental health system and also acts as a legal guardian for the patient. A conflict with the autonomy of the patient will arise if the nominated representative does not act according to the patient’s wishes and most important is the issue of assessing the competence of a patient in appointing a nominated representative. There is no objectivity in assessing the competence of a patient rather it depends upon the decision of mental health professional.

4. One of the new amendments is the inclusion of the provision of “advance directives”. Every person, irrespective of their mental health status has a right to make a written statement known as an ‘advance directive’. The ‘advance directive’ is a legal document which provides the individual with the autonomy to decide the manner in which he/she wishes to be cared for during a future period of illness. There is a necessity to certify the competence of the individual in writing an advance directive. Again there is a lack of objectivity in assessing the competence of the individual in writing an advance directive. The provision of advance directive could come in conflict with “best interest principle”. A situation may arise in which choice of treatment is contrary to the treatment mentioned by individual in advance directive. This gives rise to a dilemma for mental health professional between right to autonomy of individual and principle of beneficence.

5. In proposed amendment, no legal process is required for admission and treatment of an individual in an asylum against his/her will. Anybody who is labeled as mentally ill by a mental health care professional can be admitted against his/her will. There are no empirical methods for establishing the validity of mental illness. The petition regarding involuntary detention would be heard only after 7 days .Even the criminals are produced before magistrate within 24 hours of their arrest.

6. These amendments are likely to cost human lives. It gives the authority to an individual who has not been trained to be a physician (psychiatrist nurse and social worker) to carry out role of independent examination, diagnosis and admission of patients in mental health facilities. Shortage of mental health professionals is given as an excuse for such unethical amendment.

7. According to the new mental health care bill, 2013 children with mental illness will come under this law instead of being treated as children in need of care and protection under the Juvenile Justice Act. This law gives the authority to a mental health professional to acclaim that a parent is not capable to be guardian of a child suffering from mental illness.

9. One of the proposed amendments is on the prohibition of certain treatment of mental illness. This amendment is based on principle of non-malfeasance. It poses a ban on electro-convulsive therapy (unmodified ECT) without the use of muscle relaxants and anesthesia. The conflict between principles of non-malfeasance and beneficence arises when a patient needs immediate electro-convulsive therapy in a life threatening situation. Moreover, modified ECT is not feasible in our country because of cost and infrastructure. Also serious adverse effects are very rare with unmodified ECT. Given this, a complete prohibition on unmodified ECT is unethical as it can be dangerous to the life of a patient.

10. No attention has been given to women suffering from mental illness. Mentally challenged women are often been marginalized when it comes to government strategies and rehabilitation plans. There is an increase in the number of parents opting for sterilization of their mentally challenged daughters.

11. The mental health care bill, 2011 don’t lay emphasis on universal capacity. None of the amendments talk about the capacity building of individuals suffering from mental illness so as to enable them to make informed choices regarding their life. Instead the law provides for proxy decision making by nominated representative.

12. These proposed amendments continue to lay emphasis on the institutionalization instead of the provision of community health care. Anyone can start a mental health institute. The penalty  for such institutes set up without permission are not deterrent enough, as there is only a fine of Rs 50,000 proposed on the first offense.

A dilemma exists between ethics and laws when it comes to mental illness. There are no easy answers to these ethical dilemmas. These amendments are anti-patient and can lead to abuse of a patient. There is a need to formulate these laws from humanistic and ethical perspective.

By- Dr. Sanjida Arora

MPH-SE (Social Epidemiology)

2012-14 Batch

TISS, Mumbai

The Companies Law 2013 and the healthcare sector

Introduction:-

With the president Pranab Mukherjee giving his assent to the new companies’ bill, making it into a law, it provides for many changes in the way our companies will operate and be regulated. The new law reckons much needed changes to the 1956 legislation enacted for the same purpose as it reflects the need of the hour in terms of the changing face of the Indian industry. The next stage in the process after the parliamentary approval and the presidential assent is the process of making the rules of the new legislation, the draft of which the corporate affairs ministry is expected to roll out in a couple of weeks.
Though broadly speaking the impact of the new companies bill on sectors like manufacturing, retail, the services sector in general are usually discussed, the ramifications of this law on the healthcare and hospital sector in particular also would be worthy to take look at.

First and foremost, the question of its impact on the hospital sector becomes interesting because of the slow shift that we have been seeing in the nature of ownership of the hospitals. When the hospitals of the yesteryears were mostly charitable in nature and were not strictly under the purview of the companies’ law, but with the corporatization of the healthcare sector many of these institutions would now come under the ambit of this law. Having said this it now becomes pertinent for the healthcare managers to be aware of the new law. Let us look at some of the new features of this law.

Spending on Corporate Social Responsibility:-

This has been the most talked about topic in the new law. According to the law all corporate entities are supposed to spend 2% of its average net profits during the three preceding on CSR activities. The nature of these activities may be but not restricted to activities that help the immediate neighborhood. The CSR spending has been included to encourage the companies to create a positive impact on the immediate social fabric through their existence in the society; it would be interesting to note how the corporates view it. Though the views of some of the people in this regard seem to range from looking at this as a mere additional tax or even if in a lighter vein, it can be said that if a large industrial house is running a hospital that in itself become a CSR activity, however the essence of this new law is in the point of inclusive growth in the society in which we are serving and whose resources we are utilizing to survive. Whatever might be the different ways in which we look at it, we need to understand that, especially in case of a hospital that even when run on a purely business model it should be able to serve the community in which it is located irrespective of various financial and social barriers that limit the people from seeking treatment. With the advent of this new law let us hope that it becomes an opportunity for the healthcare providers to do this better than taking it to be a statutory burden.

Women Directors:-
The new companies’ law also stipulate that there must be at least one woman on the board of directors. The healthcare industry in India is also no exception to the “glass ceiling” phenomenon that is seen in other sectors. This is evident from the fact that tough there are a sizeable number of women in the both junior executive positions and clinical roles; the number becomes a handful when it comes to the CXO and directorial positions. At least till a point where this virtual ceiling is broken a statutory requirement would ensure that budding woman mangers wouldn't be demotivated by the inbuilt incongruities of the system.

Tighter statutory Control:-

The bitter experiences of the Satyam episode and the way in which the various investment banks in the west went belly up almost bringing the global economy to a meltdown, seems to have played its part in the formulation of the companies law as it tries to rope in many of those grey areas which let many such serious financial frauds to be overlooked, at least initially. One important thing that has been envisioned is the statutory recognition for the Serious Fraud Investigating Office (SFIO). This recognition would give more teeth to this authority to subdue erring originations right from the beginning rather than deal with them when things go awfully wrong.

Another among the reforms included the responsibilities of the auditor has been increased and this is done to take the process of audit beyond the levels of "reasonable assurance”. For this some measures like appointment of a single auditor for a period of 5 years has been included. It also stipulates that one auditor can audit a maximum of 20 companies and the inclusion of a clause for imprisonment up to one year for misleading statements etc. are all expected to bring in more accountable audit process. Other important feature has been the inclusion of the class action suites which enables even the small investors in the company to question the various policies and stopping their interests being hijacked just because of their minority value of stockholding. To top it all a separate national company law tribunal has been setup, which would now mean a more focused judicial process will follow the legislation.
The most direct impact of the above is going to be to the insurance sector. Insurance sector in India has been very keen to tap into a very large market primarily through their participations in the government schemes like the RSBY. In a way insurance is poised today is akin to the IT sector in India and the financial services growth in the USA and the pattern of development is indicative of a Damocles sword hanging, some of the evidence of which can be seen in the recent allegations against a major insurance company of having the government to cough up crores as premium for ghost beneficiaries. It is the right time to bring in such regulations to nip some of these nefarious tendencies in the bud.

For Entrepreneurs:-
One of the new features of this law that would be of interest for the upcoming entrepreneurs is that it allows for a one person company. This is a welcome move for the fact that healthcare has become one of the hotbeds for spurt in entrepreneurial activities using various IT platforms and solutions which essentially opens up the possibilities of one person companies to a greater extent than ever before.

Another feature of the new law, though a one which would be one of the worst nightmares for any entrepreneur to encounter is that the employer is supposed to pay all employees 2 years of salary in advance on winding up of operations.

Conclusion:-
Though the complete ramification of the new law can only be fully understood after the rules are framed and it is executed, but in a nutshell we can surely say that the new companies bill is a right step in fortifying the functioning of the corporates and making them more grounded into the society in which they are. But as with all the laws in India, the execution is where it falters, let us hope that this new law provides a framework for improvement of our corporate ecosystem and it gets adapted in both letter and spirit.

By - Vivin George

MHA-Hospital Administration
2012-2014 Batch
TISS, Mumbai