Tag Archives: Country

Are common patients in India just as the pawns of the game of chess or the victims of circumstances or both, in the socio-economic milieu of the country?

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“Public healthcare in India has the power to deliver improved health outcomes, as demonstrated by a growing number of national and international examples. However, supportive policies need to be put in place in order to change traditional determinants of health,”said Professor Sir Andrew Haines, Director, London School of Hygiene and Tropical Medicine at the third foundation day function of the Public Health Foundation of India (PHFI), not so long ago.The healthcare industry of India has indeed this power, which can catapult the industry to a growth orbit to generate an impressive revenue of around US$.150 billion by 2017 as estimated by India Brand Equity Foundation (IBEF) in November 2009. This growth will be driven primarily by the private investments in country.Be that as it may, the current healthcare standard and infrastructure in India, as we all know, is far from satisfactory. Though we have some healthcare centers of excellence spread sporadically across various cities and towns of India, public healthcare facilities are grossly inadequate to satisfy the current healthcare demand of the common man of India.

Healthcare spends in India:

Although total health spending of the nation is around 6 percent of its GDP being one of the highest within the developing countries of the world, public expenditure towards healthcare is mere 0.9 percent of the GDP and constitutes just a quarter of the total healthcare cost of the nation. According to a World Bank study, around 75 percent of the per capita spending are out of pocket expenditure of individual households, state and the union governments contribute around 15.2 percent and 5.2 percent respectively, health insurance and employers contribute just 3.3 percent and foreign donors and state municipalities contributing the balance of 1.3 percent.

Out of this meager allocated expenditure only 58.7% goes for the primary care.

Four essentials in Primary Healthcare:

When it comes to Primary Healthcare, following are the well accepted essentials that the government should effectively address:

1. Healthcare coverage to all, through adequate supply of affordable medicines and medical services

2. Patient centric primary healthcare infrastructure and networks

3. Participative management of healthcare delivery models including all stakeholders with a change from ‘supply driven’ to ‘demand driven’ healthcare program and policies

4. Health of the citizens should come in the forefront while formulating all policies for all sectors including industry, environment, education, deployment of labor, just to cite a few examples.

It is unfortunate that most of these essentials have not seen the light of the day, as yet.

The key reason for failure:

Inability on the part of the central government to effectively integrate healthcare with socio-economic, social hygiene, education, nutrition and sanitation related issues is one of the key factors for failure in this critical area.

Moreover in the healthcare planning process, health being a state subject, not much of coordinated planning has so far taken place between the central and the state governments to address the pressing healthcare related issues.

In addition, budgetary allocation and other fiscal measures, as stated earlier, towards healthcare both by the central and the state governments are grossly in adequate.

National Rural Health Mission (NRHM) – a good beginning:

To address this critical issue, the National Rural Health Mission (NRHM) was conceived and announced by the government of India. NRHM aims at providing valuable healthcare services to rural households of the 18 States of the country namely, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Himachal Pradesh, Jharkhand, Jammu and Kashmir, Manipur, Mizoram, Meghalaya, Madhya Pradesh, Nagaland, Orissa, Rajasthan, Sikkim, Tripura, Uttarkhand and Uttar Pradesh, to start with.

The key objectives of this novel scheme are as follows:

• Decrease the infant and maternal mortality rate
• Provide access to public health services for every citizen
• Prevent and control communicable and non-communicable diseases
• Control population as well as ensure gender and demographic balance
• Encourage a healthy lifestyle and alternative systems of medicine through AYUSH

As announced by the government NRHM envisages achieving its objective by strengthening “Panchayati Raj Institutions” and promoting access to improved healthcare through the “Accredited Female Health Activist” (ASHA). It also plans on strengthening existing Primary Health Centers, Community Health Centers and District Health Missions, in addition to making maximum use of Non-Governmental Organizations.

NRHM is expected to improve access to healthcare by 20 to 25 percent in the next three years:

To many the National Rural Health Mission (NRHM) has made a significant difference to the rural health care system in India. It now appears that many more state governments are envisaging to come out with innovative ideas to attract and retain public healthcare professionals in rural areas.

On January 11, 2010, the Health Minister of India Mr. Ghulam Nabi Azad, while inaugurating the FDA headquarters of the Western Zone located in Mumbai, clearly articulated that the NRHM initiative will help improving access to affordable healthcare and modern medicines by around 20 to 25 percent during the next three years. This means that during this period access to modern medicines will increase from the current 35 percent to 60 percent of the population.

If this good intention of the minister gets translated into reality, India will make tremendous progress in the space of healthcare, confirming the remarks made by Professor Sir Andrew Haines, Director, London School of Hygiene and Tropical Medicine, as quoted above.

Is NRHM scheme good enough to address all the healthcare needs of the country?

NRHM is indeed a very good and noble initiative taken by the government to address the basic healthcare needs of the rural population, especially the marginalized section of the society. However, this is obviously not expected to work as a magic wand to resolve all the healthcare related issues of the country.

Are patients the pawns of the game of chess or the victims of circumstances or both of the socio-economic systems?

Currently, some important stakeholders of the healthcare industry seem to be using the patients or taking their names, mainly for petty commercials gains or strategic commercial advantages. They could be doctors, hospitals, diagnostic centers, pharmaceutical industry, activists, politicians or any other stakeholders. It is unfortunate that they all, sometime or the other, want to use the patients to achieve their respective commercial or political goals or to achieve competitive gains of various types or just for vested interests..

‘The Patient centric approach’ has now become the buzz word for all – do we ‘walk the talk’?

There does not seem to be much inclusiveness in the entire scheme of things in the private healthcare system, excepting some odd but fascinating examples like Dr. Devi Shetty, Sankara Nethralaya etc. As a result, excepting the creamy layers, patients from all other strata of society are finding it difficult to bear the treatment cost of expensive private healthcare facilities.

I personally know a working lady with a name Kajol (name changed) whose husband is suffering from blood cancer. One will feel very sad to watch how is she fast losing all her life’s savings for the treatment of her husband, pushing herself, having no alternative means, towards an extremely difficult situation day by day. There are millions of such Kajols in our society, who are denied of effective public healthcare alternatives to save lives of their loved ones.

If all stakeholders are so “patient centric” in attaining their respective objectives, why will over 650 million people of India not have access to modern medicines, even today? Is it ALL for poor healthcare infrastructure and healthcare delivery system in the country? If so, why do we have millions of Kajol’s in our country?

Consumer awareness and pressure on healthcare services and medicines in India will increase – a change for the better:

With the winds of economic change, rising general income levels especially of the middle income population, faster awareness and penetration of health insurance among the common citizens, over a period of time Indian consumers in general and the patients, in particular, like in the developed countries of the world, will start taking more and more informed decisions by themselves about their healthcare needs and related expenditure through their healthcare providers.

As the private healthcare providers will emerge in India, much more in number, like the developed world, they will concentrate not only on their financial and operational efficiencies exerting immense pressure on other stakeholders to squeeze out the best deal at the minimal cost, but also to remain competitive will start charting many uncharted frontiers and explore ways of enhancing the ‘feel good factors’ of the patients through various innovative ways… God willing.

Conclusion:

All stakeholders of the healthcare industry need to think of inclusive growth, not just the commercial growth, which could further widen the socio-economic divide in the country, creating numbers of serious social issues. As we know, this divide has already started widening at a brisk pace, especially in the healthcare sector of the country

It is hightime for the civil society, as well, to ponder and actively participate to make sure that the inclusive growth of the healthcare sector in India takes place, where like primary education, primary healthcare should be the ‘fundamental right’ for ALL citizens of the country.

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.

The relevance of the Indian version of the Bayh-Dole Act – the country needs all stakeholders’ open debate on the proposed bill.

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The Bayh-Dole Act is an American legislation, which was originally sponsored by two US senators named Birch Bayh and Bob Dole. This Act deals with Intellectual Property (IP) arising out of US government funding. Bayh-Dole Act is also known as University and Small Business Patent Procedure Act. In December 12, 1980 this was enacted into a law by the US Congress.
What it does:
Under this Act, IP rights over government funded inventions for further development, license to other parties or direct commercialization are transferred to the universities and small businesses operating with government contracts. The government though retains its right to license the invention to any third party without any consent from the IP right owner or the licensee, if it feels that on a reasonable basis the public is being denied of the benefits of the invention.

The Indian version of the Bayh-Dole Act:

The Utilization of the Public Funded Intellectual Property Bill 2008, which has been formulated in line with the US Bayh-Dole Act, has already been approved by the Union Cabinet of India. This bill ensures both utilization and protection of the IP arising out of government funded research initiatives. Currently government funded academic institutions and research institutes cannot commercialize the inventions.

The proposed bill will not only allow them to patent such inventions but will also reward the inventors and the institutes with a share of its commercialization proceeds as per specific guidelines.
The bill has attracted a mixed response from the stake holders.

The relevance of Bayh-Dole Act in India:

Relevance of Indian version of the Bayh-Doll Bill in the post product patent regime in India is
significant. The core concept of the bill encourages innovation and ensures protection of patents and other forms of IP rights of the government funded R&D outcomes, where the owner of the intellectual property will be the government grant receipients or the government.

This bill is expected to offer to various research institutions, universities, small businesses and non-profit organizations, the IP rights on their inventions, resulted from the government funding. Overall environment towards innovation within the country is expected to get a boost in that process.

Is the ownership and protection of R&D a real remedy to make government academic institutions and universities self sustainable?

This is certainly not the only remedy, but an important one. This process will have significant potential to effectively facilitate technology transfer from government funded research laboratories or universities to the user industry to make these establishments self-sustainable.

What are the main implications of the bill if enacted in its current form?

Although the fine prints of the bill are not yet clearly known, the bill in its current form raises more questions than answers. Some of the concerns with the bill in its current form are as follows:

- This law could effectively transfer the decision making process about
publications of the research papers from the researchers and academia to
the bureaucrats in the government establishments, making the R&D
environment quite stifling for the researchers and the initiative
counterproductive.

- Academia at times will be compelled to incur significant expenditures
towards different types of IPR related litigation, which could have been
otherwise productively spent by these institutions towards research
initiatives.

- The learning and research may get transformed into another kind of
businesses activity, as such a law could change the research focus on to
the issues, which will be of greater commercial interest to various
industries and will offer immediate financial benefits to the
institutions. As a result vital non-commercial research, which could be of
critical interest to the nation as such, may take a back seat.

Conclusion:

The country will therefore need an extensive public debate on this bill, which has not taken place, as yet. The loose knots of the bill need to be tightened and the concerns of the stakeholders need to be adequately addressed before its enactment into a law.

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.

Patent Linkage: an important step yet to be taken by the Government of India for proper enforcement of product patents granted in the country

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The process of Patent Linkage establishes a desirable communication process between the Health Ministry and the Patent Offices to prevent marketing approval of generic drugs before expiration of patents granted in India. It also ensures that one Government Department / Ministry does not impair the efforts of another Government Department / Ministry to provide effective intellectual property protection as required by Article 28 of the WTO TRIPS Agreement.
The system of Patent Linkage exists around the world:Following are some examples:

Australia – Health Authorities do not provide marketing approval for a generic copy which would infringe an existing patent.

Brazil – As of 2006, no copies of products still under patent have been launched in the market place. However, the Brazilian Health Agency (ANVISA), grants registration to copy products, based only on the merits of the case from the regulatory point of view, whether or not a patent has been granted for the same.

Canada – Health Regulatory Authorities do not provide marketing approval for pharmaceutical products protected by patents listed in the equivalent of the US FDA Orange Book.

China – The State Food & Drugs Administration (SFDA) must be satisfied that no patent is being infringed before it will issue marketing approval. If there has been litigation over a patent, SFDA will wait until the appeals process has been exhausted before acting.

Jordan – Marketing approval for a pharmaceutical product is not permitted during the period of patent protection.

Mexico – Applicants seeking marketing approval for generic pharmaceutical products in Mexico must certify that their patent rights are not infringed. The Health Regulatory Authorities then check with the Patent Office, which must respond within ten days to confirm whether a patent is involved. While Health Authorities will accept an application of marketing approval during the patent period, grant of marketing approval will be delayed until the patent expires.

Singapore – Applicants seeking marketing approval for generic pharmaceutical products in Singapore must declare that the application does not infringe any patent.

U.A.E – The Health Regulatory Authorities do not provide marketing approval for pharmaceutical products that remain under patent protection in the country.

U.S.A – U.S. FDA maintains a listing of pharmaceutical products known as the Orange Book. The Electronic Orange Book is also available via the internet at: http://ww.fda.gov/cder/ob The U.S. FDA does not authorize the marketing approval for a generic copy of a pharmaceutical product protected by a patent listed in the Orange Book.

Europe – Instead of Patent Linkage, the period of data exclusivity is for 10/11 years.

The Patent Linkage System is in progress in countries like Bahrain, Chile, Dominican Republic – Central America FTA (DR-CAFTA), Morocco and Oman.

Some people question why should India follow Patent Linkage system in the regulatory approval process?

In India ground realities in the patent enforcement process are quite unique. Thus there is an urgent need for having a Patent Linkage system in place for the following reasons:

1. The Government is granting product patent to encourage, protect and reward innovation in India, it will not be in the best interest of the innovators if the same Government grants marketing approval for a generic equivalent of the patented molecule during the patent life of the product.

2. Unlike many other countries, the Indian Patent Law has provision for both pre-grant and post-grant oppositions. Therefore, if anyone wants to challenge the patent, enough time will be available for the same.

3. After patent is granted for a product in India, if marketing approval is given to a generic equivalent of the same molecule, a dispute or patent infringement may arise. As per the Patents Act 2005, such disputes regarding patent infringement have to be challenged in a High Court. The judicial process is a long drawn one and it is quite possible that the patent life of the concerned molecule would expire during the dispute settlement period, which in turn, would raise doubts about the sanctity of granting a product patent to an innovator in our country.

Conclusions:

I therefore submit the following recommendations to ensure proper enforcement of products patent in India:

 The status of the grant of patent should be reviewed, through appropriate drug regulatory mechanism, before granting marketing permission to generic formulations and if the concerned innovative product is already patented in India, marketing permission for the generic formulation should be withheld.

 Appropriate mechanism/system should soon be worked out in co-ordination with other Ministries to avoid cases of infringement of product patents in India.

 The procedure (Patent Linkage) of checking the patent status of a product before granting marketing approval already exists in the Form 44. This procedure needs to be implemented.

India has instances where marketing permission has been granted by the DCGI for a generic product even when a product patent already exists for the same molecule in India. Such instances put the patent holder in a hardship and avoidable litigation involving huge resources both in terms of time and money. Situation like this can be effectively avoided by ascertaining the patent status before granting marketing permission to a generic manufacturer through an appropriate drug regulatory system, as indicated above.

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.