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R&D and Protection of IPR related to Pharma sector, are now the responsibilities of the Department of Pharmaceuticals (DoP) – a quick look at the initiatives taken by the department.

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On July 2, 2008, the Cabinet Secretariat of the Government of India notified creation of a new department to be known as the Department of Pharmaceuticals (DoP) under the Ministry of Chemicals and Fertilisers with an objective to have a sharper focus on the Pharmaceuticals Industry of India. In that notification besides other important areas, Research and Development (R&D) and protection of Intellectual Property Rights (IPR) related to the Pharmaceutical sector, were brought under the newly created department.In this discussion let us try to have a look at the progress in both the R&D and IPRareas, separately.After creation of the new department, the Minister of Chemicals and Fertilisers Shri Ram Vilas Paswan, announced a proposed allocation of Rs. 10,000 crores (around US$ 2 billion), together with necessary regulatory reforms, towards annual Pharmaceutical R&D funding by the DoP.

The Government expects that such initiatives will help bringing in transformation of the Indian Pharmaceutical Industry from brilliant and highly successful ‘imitators’ to world class ‘innovators’ of path breaking medicines. Discovery of such medicines in India is also expected to help the Government significantly, to improve access to affordable innovative modern medicines to the common man of the country. All these are no doubt, very laudable initiatives by the DoP, with a very capable, effective and a ‘can do’ leader at its helm.

The DoP plans to bring in significant changes in the clinical trial facilities available within the country. Currently even very basic clinical trials on ‘dogs’ cannot be undertaken because of protests from the activists related to ‘prevention of cruelty on animals’. Such reform measures, I am sure, will be sincerely welcomed by many.

It is interesting to note that the DoP is also planning to extend Regulatory Data Protection (RDP) to innovators. It has been reported that the invaluable data generated by the innovators towards development of the New Molecular Entity (NME) will, in near future, be protected from ‘piracy’ during 20 year patent life of the product. However, the DoP cautions that attempt to ‘evergreen patent’ through data protection, beyond the patent life of a product will not be permitted.

The argument of the innovators on this issue is that Product Patent and Clinical Data are two different types of intellectual properties and should not be considered as one and the same. While patent protection is extended for discovery of the molecule, data protection is for the immense and expensive clinical data that the innovators share with the Government for regulatory approval of the patented molecule, within the country. The argument that such valuable data generated by the innovators is an intellectual property (IP), lies in the premise that if the innovator would not have been required to part with the data with the regulatory authorities, such data would have been regarded as a ‘trade secret’, which is an IP. Therefore, the innovators argue that for sharing this IP with the Government, specific period of data protection to be extended to them, which should be unrelated to the life of the patent.

Thus far, we see that DoP has taken some very important and admirable initiatives to encourage R&D within the country. However, while looking at another important area of its responsibility i.e. protection of IPR within the Pharmaceutical sector, nothing has been announced by the department, as yet.

Encouraging R&D without effective protection of IPR, points towards an incomplete agenda to effectively address pharmaceutical product innovation related issues by the department. I sincerely hope that the DoP will soon announce its policy initiatives towards IPR protection to further encourage the innovators, both within and outside the country.

The DoP has taken some significant steps to address various important issues of the pharmaceutical industry under its terms of reference, within a very short period. I look forward to knowing from the DoP the detail initiatives in each of its nine functions and responsibilities, as announced in the notification of the cabinet secretariat on July 2, 2008.

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.

An integrated approach towards Public Private Partnership (PPP) initiatives to improve access to healthcare in India is the way forward.

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Despite so much of stringent government control, debate and activism on the affordability of modern medicines in India, on the one hand, and the success of the government to make medicines available in the country at a price, which is cheaper than even Pakistan, Bangladesh and Sri Lanka, on the other, the fact still remains, about 65% of Indian population do not have access to affordable modern medicines, compared to 15% in China and 22% in Africa.The moot question therefore is, despite all these stringent price regulation measures by the government and prolonged public debates over nearly four decades or so to ensure better ‘affordability of medicines’, why then the situation on ‘access to modern medicines’has remained so abysmal to a vast majority of the population, in India?This, in my view, is mainly because; no single minister or ministry can now be held accountable by the civil society for such a dismal performance in the access to healthcare, in India.

Poor healthcare infrastructure:

As per the Government’s own estimate, India records:

1. A shortage of 4803 Primary Health Centres (PHC)

2. A shortage of 2653 Community Health Centres (CHC)

3. No large Public Hospitals in rural areas where over 70% of the populations live

4. Density of doctors in India is just 0.6 per 1000 population against 1.4 and 0.8 per 1000 population in China and Pakistan respectively, as reported by WHO.

The Government spending in India towards healthcare is just 1.1% of GDP, against 2% by China and 1.6% by Sri Lanka, as reported by the WHO.

Some good but sporadic public healthcare initiatives:

The government allocation of around US$ 2.3 billion for the National Rural Health Mission (NRHM), is a good initiative to bring about uniformity in quality of preventive and curative healthcare in rural areas across the country.
While hoping for the success of NRHM, inadequacy of the current rural healthcare infrastructure with about 80 percent of doctors, 75 percent dispensaries and 60 percent of hospitals located only in the urban India, may encourage skepticism.

Addressing the issue of improving access to healthcare:

While addressing the issue of improving access of healthcare, following three important ‘Public Private Partnership (PPP)’ initiatives would be most appropriate.

1. PPP to improve affordability:

To address this vexing problem, industry associations had jointly suggested a policy shift towards public-private-partnership (PPP) model to the government in 2006-07, instead of a stringent price control mechanism, which has not worked thus far to improve access of modern medicines, in India. Instead, the associations seemed to have suggested that the pharmaceutical industry will supply to the government the essential medicines at 50% of their Maximum Retail Price (MRP), to cater to the need of below the poverty line (BPL) families.

It is worth mentioning, many OPPI member companies like, Novartis, GSK, Pfizer, Sanofi-Aventis etc. have their own access to medicines programs in India.

Although the government did not respond to this proposal, to make it effective the ministry of health will require to quickly initiate significant ‘capacity building’ exercises, both in the primary and also in the secondary public healthcare facilities in the country. FICCI is reported to have suggested to the Government for an investment of around US$ 80 billion to create over 2 million hospital beds, for such capacity building exercises .

Frugal budget allocation by the government towards healthcare of the country, suggests that Government is gradually shifting its role in this very important area, primarily from healthcare provider to healthcare facilitator for the private sectors to develop it further. If it is so, it is imperative for the government to realize that the lack of even basic primary healthcare infrastructure, leave aside other incentives, impede effective penetration of private sectors into semi-urban and rural areas. Effective PPP model should be worked out to address such issues, without further delay.

2. PPP to leverage the strength of Information Technology (IT) to considerably neutralize the system weaknesses:

Excellence in ‘Information Technology’ (IT) is one of the well recognized strengths that India currently possesses. This strengths needs to be adequately leveraged through PPP to neutralize the above weaknesses. Harnessing IT strengths, especially in the areas of drug procurement and delivery processes, especially in remote places, could hone the healthcare delivery mechanism, immensely.

Another IT enabled technology that India can widely use across the nation to address rural healthcare issues is ‘‘Telemedicine’ for distant diagnosis and treatment of ailments. Required medicines for treatment could be made available to the patients through ‘Jan Aushadhi’ initiative of the Department of Pharmaceuticals (DoP), by utilising the Government controlled distribution outlets like, public distribution system (ration shops) and post offices, which are located even in far flung and remote villages of India.

3. PPP in healthcare financing for all:

Unlike many other countries, even as compared to China, over 72 percent of Indian population pay out of pocket to meet their healthcare expenses.

Out of a population of 1.3 billion in China, 250 million are covered by insurance; another 250 million are partially covered by insurance and balance 800 million are not covered by any insurance. Converse to this scenario, in India total number of population who may have some sort of healthcare financing coverage will be around 200 million with penetration of health insurance at just around 3.5% of the population. India is fast losing grounds to China mainly due to better response to healthcare infrastructure.

Even after leveraging IT for ‘Telemedicine’ and improving healthcare delivery processes, together with availability of low priced quality medicines from ‘Jan Aushadhi’ outlets, a robust healthcare financing model for all strata of society to make healthcare products/services affordable to a vast majority of the population, will remain an essential requirement for the country to address the issue of improving access to healthcare to all.

According to a survey done by National Sample Survey Organisation (NSSO), 40% of the people hospitalised in India borrow money or sell assets to cover their medical expenses. A large number of populations cannot afford to pay for the required treatment, at all.

Conclusion:

In my view an integrated approach for creating effective healthcare infrastructure throughout the country, leveraging IT in the entire healthcare space, appropriately structured ‘Health Insurance’ schemes for all strata of society ably supported by well spread out ‘Jan Aushadhi’ outlets even in far flung rural areas, deserve careful consideration by the Government.

A PPP model in all these three areas needs to be worked out in detail to address the pressing issue of improving ‘Access to Affordable Integrated Healthcare to ALL’.

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.