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National Non-Communicable Disease (NCD) prevention program of the government needs a new thrust to contain the burden of disease in India.

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The disease pattern in India is showing a perceptible shift from the age old ‘Infectious Diseases’ to ‘Non-infectious Chronic Illnesses’. As reported by IMS, incidence of chronic ailments in India has increased from 23 percent in 2005 to 26 percent in 2009. It is estimated that chronic illnesses will be the leading cause of both morbidity and mortality by the next decade.As a consequence of such changing disease pattern, healthcare needs and related systems of the country should undergo a paradigm shift together with the emergence of a carefully planned concept of ‘Preventive Healthcare’ for the entire population of the nation.
It is a myth that non-infectious illnesses are more prevalent in higher socio-economic strata:

There is a common perception that non-communicable diseases are more prevalent within higher socio-economic strata of the society. However, a national survey done in India shows that diseases related to misuse of alcohol and tobacco are higher in the poorest 20 percent quintile of our society.

Current healthcare system in India:

Currently with appropriate disease treatment measures, alleviation of acute symptoms of the disease that a particular patient is suffering from, is the key concern of all concerned starting from the doctors to the patients and their family. The process of the medical intervention revolves round treatment protocols and procedures based on the diagnosis of the current ailments and not so much on preventive measures for other underlying diseases, except with the use of vaccines for some specific diseases.

Developing a protocol for ‘Preventive Healthcare’ for non-communicable diseases is very important:

In the above process, while addressing the acute problems of the patients’ current ailments is very important, proper risk assessment of other underlying diseases, if any, which the patient could suffer from in future, for various reasons, do not attract any organized attention. As a result the important advice on preventive healthcare from the doctors, properly highlighting its importance, is not available to most of the patients to enable them to significantly reduce, if not eliminate, their future burden of disease.

Keeping such common practices in view and noting that ‘Preventive Healthcare’ is significantly different from ‘Curative Healthcare’, developing an appropriate protocol for ‘Preventive Healthcare’ has become a crying need of the hour.

‘Preventive Healthcare’ in India should attract high priority of the healthcare policy makers with a care vigil on its effective implementation at the ground level:

All said and done, the ‘Preventive Healthcare’ system in India is in its very nascent stage. If appropriate measures are taken in this area, like learning to reduce the impact of mental and physical stress, avoiding sedentary life style, taking healthy diet, avoidance of tobacco and alcohol consumption, leading healthy sex life etc., it can in turn immensely help the population to remain disease free and healthy, thereby contributing to improvement of their respective work productivity in a very substantial way.

The Medical Council of India should also step in:

Thus the role of medical professionals in the disease prevention process is also very important. The interaction of the patients with the doctors when they meet to address any ailment provides huge opportunity to the doctors to advise those patients about various measures of underlying disease prevention, for which different patients have different types of exposures.

Keeping all these points in view, through regulatory initiatives, the Medical Council of India (MCI) should consider making ‘Preventive Healthcare’ an integral part of each interaction of a patient with a doctor.

Include the civil society in the healthcare improvement process of the nation:

The risk factors of many of the diseases like, cancer, chronic respiratory disorders, cardiovascular, diabetes, and hypertension can be identified well in advance and appropriately assessed. Therefore, such diseases can be prevented effectively, to a great extent, provided the healthcare policy of the country supports the ‘Disease Prevention’ process, program and initiatives through adequate resource allocation, improving awareness of the civil society and above all including them in this healthcare improvement process of the nation.

Need to raise general awareness towards ‘Preventive Healthcare’:

Raising the level of awareness of ‘Preventive Healthcare’ is indeed very important. It requires a change in the mindset of the community in general, together with the healthcare policy makers, medical profession, employers, patients and their families.

National Non-Communicable Disease (NCD) prevention program of the government:

As per the planning commission, the government of India has initiated the following structured measures for the prevention of NCD:

• “Health education for primary and secondary prevention of NCDs through mobilizing community action;
• Development of treatment protocols for education and training of physicians in the prevention and management of NCDs:
• Strengthening/creation of facilities for the diagnosis and treatment of CVD and stroke, and the establishment of referral linkages;
• Promotion of the production of affordable drugs to combat diabetes, hypertension, and myocardial infarction;
• Development and support of institutions for the rehabilitation of people with disabilities;
• Research support for: Multispectral population-based interventions to reduce risk factors;
• The role of nutrition and lifestyle-related factors;
• The development of cost effective interventions at each level of care”.

Conclusion:

Many diseases in India, with proper ‘Disease Prevention’ measures can be effectively averted. It is worth repeating that some common measures which can be easily practiced through community initiatives are maintenance of proper hygiene, sanitation, adequate physical activities, moderation in alcohol and tobacco consumption, healthy sexual activities, avoidance of unhealthy food etc.

Besides, the government should spearhead the paradigm change towards ‘Preventive healthcare’ by including the civil society as a part of this process along with appropriate regulations wherever necessary, generating increased awareness within all concerned and through mobilization of adequate resources. All these will ultimately help all of us to translate the well-known dictum into reality, ‘Prevention is better than cure’.

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.

To avoid “Heparin” like tragedy in future, a robust “supply chain integrity and security” system is of critical importance

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Globally the pharmaceutical industry is going through a metamorphosis. The types of changes that are taking place today globally, perhaps has no precedence..

The key drivers of these changes are mainly the following:

1. A large number of patent expiration hugely impacting the top-line growth
2. Research pipeline is drying-up
3. The cost of bringing a new molecule from the ‘mind to market’ has now touched around U.S$ 1.75 billion
4. Regulatory requirement to get the marketing approval is getting more and more stringent, basically for patients’ safety, making clinical development more expensive and time consuming
5. Cost containment measures of various governments around the world is putting an immense pressure on product price, adversely affecting the profit margin

Strategic measures of enormous significance:

All these are triggering other sets of consequential events of enormous significance. Among those following key corporate strategic measures indeed stand out:

1. More mergers and acquisitions of various sizes and scales to achieve both revenue and cost synergy, with new products and newer types of resources
2. Transformation in the fundamental operating models, e.g. R&D focused companies like Pfizer, GSK, sanofi aventis are extending their business interest to the pharmaceutical generics space
3. Increasing globalization and greater focus on the emerging markets of the world like, Brazil, Russia, India, China, Turkey, Mexico
4. Growing emphasis on partnering, as we see in India, like for example, between Pfizer and Aurobindo, Claris, GSK with Dr. Reddy’s Lab (DRL)
5. Global outsourcing in the ‘Contract Research and Manufacturing Services (CRAMs)’’space, mainly to rationalize costs and deliver the bottom lines, when the top line is under immense pressure.

Demand on all round effectiveness of the “Supply Chain”:
The changing requirements of all types, in sales and marketing, manufacturing and research and development have created a challenging, if not a rather volatile operating environment. In this situation supply chain will increasingly play a key role to ensure that the right product is available at the right place, at the right time, at a right price and following the right process…always.

Outsourcing initiative is not just about cost:
There is at the same time, a new trend emerging for increased outsourcing initiative, especially from countries like India and China. This initiative, which in turn is in the process of making these two countries the key global outsourcing hubs, is definitely not all due to just cost advantages. It encompasses increased integrated value proposition for the customers. Cost is just one of the key factors, others being quality, speed and suppliers’ reliability. Nothing in this value chain is mutually exclusive. Supply Chain will need to go through a set of complex algorithms to strike a right balance between all these vital parameters.

Robust “supply chain integrity and security’ will assume critical importance:
In the days to come by one of the greatest challenges in supply chain management will be to improve the supply chain integrity and security.
An appropriate definition of integrity for supply chains is:

“the requirement that the system performs its intended function in an unimpaired manner, free from deliberate or inadvertent manipulation.”
A safe and secure supply chain is definitely not a new requirement. However, in the list of priority of importance, it has now come up significantly compared to what it was just a few years back.

Are the pharmaceutical companies aligned on this issue?
Though the issue of improving the supply chain integrity and security has now assumed global importance, unfortunately, any uniformity in national regulatory requirements for this vital parameter is glaringly missing. Such a lack of regulatory uniformity clearly highlights that the pharmaceutical companies, engaged in manufacturing, are still not aligned with each other on what will be the right way to ensure absolute integrity, safety and security in the supply chain operating process to guarantee patients’ safety.

RFID is just one component of supply chain integrity:
Globally many Pharmaceutical Companies are getting engaged in improving supply chain integrity, security and patient safety with the introduction RFID. This, as many may know, is an inventory tracking system for improved product traceability, which in turn extends some protection to its customers with genuine products from the genuine pharmaceutical manufacturers. It is worth noting that RFID is just one component of overall patients’ safety initiative.

Suppliers’ qualification process through stringent ‘supplier audit’ is of critical importance:
Along with high tech measures like RFID, to improve supply chain integrity, I reckon, pharmaceutical companies will need to further enhance their respective supplier qualification process.
The process of supplier audits should include all important and critical areas of manufacturing, testing and quality, related to each individual product. Only a stringent supplier qualification process will be able to guarantee integrity, safety and the quality of products from the suppliers.

Heparin tragedy, where the supply chain integrity was grossly violated:
Before I conclude, I would like reinforce my recommendation with the example of Heparin tragedy where the supply chain integrity was violated and seriously challenged thereafter.

In the beginning of 2008, there were media reports on serious adverse drug events, some even fatal, with Heparin, a highly-sulfated glycosaminoglycan of Baxter International. Heparin is widely used as an injectable anticoagulant. Baxter voluntarily recalled almost all their Heparin products in the U.S. Around 80 people died from contaminated Heparin products in the U.S. The US FDA reported that such contaminated Heparin was detected from at least 12 other countries.

A joint investigation conducted by Baxter and the US FDA ascertained that the Heparin used in batches associated with the serious adverse drug events was contaminated with over sulfated chondroitin sulfate (OSCS). It was reported that his Heparin was supplied to Baxter by Scientific Protein Laboratories, Changzhou, China.

The cost of OSCS is just a fraction of the ingredient used in Heparin. Being driven by the criminal profiteering motive the manufacturers in Changzhou, China had reportedly used OSCS for highly-sulfated glycosaminoglycan as the former could not be detected by the pharmacopeia test in use, until 2008. This is because OSCS mimics Heparin in the pharmacopeia test and thus could not be detected in the case in question.
Post this criminal event, at present, all over the world more specific pharmacopeia test methods have been adopted for Heparin.

Conclusion:
Let us all ensure that such a tragedy does not get repeated in future due to a breach in the supply chain integrity, anywhere in the world…for the patients’ sake.
In today’s deliberations I am sure this issue will be touched upon to ponder over the possible implementable steps to address such future threats effectively.

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 Union Budget 2010-11…the issue of improving access to healthcare…encouraging innovation… and beyond

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The Primary role of the pharmaceutical industry in India, like in many other countries of the world, is to make significant contribution to the healthcare objectives of the nation by meeting the needs of the ailing patients through improved access to modern medicines.

This role could be fulfilled primarily in the three following ways through Public Private Partnership initiatives:

1. By improving the healthcare infrastructure and the healthcare delivery systems
2. By creating a favorable echo system for developing newer innovative medicines through R&D initiatives in the country
3. By taking policy measures towards a robust healthcare financing system for all strata of our society

Improving access to modern medicines:

In the Union Budget 2010–11, the Finance Minister has proposed an increase in allocation towards healthcare from Rs. 19,354 Crore to Rs. 22,300 Crore. It is expected that a significant part of this increased allocation will be utilized in improving healthcare infrastructure and delivery systems, in the country.

Moreover, extension of ‘Tax Holiday’ for hospitals set-up in rural areas from 5 to 10 years, is expected to encourage development of rural healthcare infrastructure. The Finance Minister has also proposed that ‘Tax Holiday’ will be available for hospitals set-up even outside rural areas.

The proposal for extension of health insurance to NREGA beneficiaries is also expected to have a positive impact in improving access to modern medicines within this sector of the population.

It is my strong belief that currently, improving access to healthcare in general and medicines in particular along with encouraging innovation, should be the top-priorities of our policy makers. High incidence of mortality and morbidity burden in a country like ours can only be addressed through such priority measures. It is believed that Indian Pharmaceutical Industry would always remain committed to actively support all such efforts from all corners to help achieving this objective.

Encouraging innovation:

The budgetary proposal of enhancement of scope of weighted deduction on expenditure incurred on in-house R&D to 200% and the same on payments made to national laboratories, research associations, colleges, universities and other institutions for scientific research to 175%, are welcome steps.

However, in my view only the above steps are not adequate enough to properly encourage innovation within the country. Ongoing efforts in Research & Development (R&D) would require a robust national policy environment that would encourage, protect and reward innovation. Improving healthcare environment in partnership with the Government remains a priority for the pharmaceutical industry in India.

Despite progress made over the past decades in developing new medicines for some acute and chronic illnesses by both the Indian pharmaceutical companies and R&D organizations, innovation, like in other developed countries, still remains critically important in the continuous and ever complex battle between disease and good health in India.

Other encouraging budget proposals:

The following proposals of the Finance Minister are also expected to benefit the Industry:

- An annual Health Survey to prepare the District Health Profile of all districts in 2010-11

- Uniform concessional basic duty of 5% for all medical appliances and exemption of import duty from specified inputs for the manufacture of orthopedic implants, are good initiatives.

- Reduction of Corporate surcharge from 10% to 7.5%, though corporate Minimum Alternate Tax has gone up to 18%

- Tax incentives for the business of setting up and operating “Cold Chain” infrastructure, which is an integral part in the logistics for vaccines and many biotech products

- Under section 10B, extension of sunset clause is expected to benefit the Export Oriented Units (EOUs)

Adverse impact on affordability:

Some steps taken in the Union budget may have major impact on the Indian Pharmaceutical Industry, which are as follows:

• Goods and Service Tax (GST) coming in April 1, 2011 and Minimum Alternate Tax (MAT) hiked to 18% could prompt restructuring of ‘supply chain’ of many companies

• Increase in fuel prices and withdrawal of ‘Service Tax’ exemption on transportation of goods by rail, could make pharmaceutical products more expensive.

The Union Budget 2010–11, which has been largely hailed as a good budget across the industry, unfortunately does not propose much in terms of major fiscal and policy measures for the pharmaceutical industry.

Conclusion:

Be that as it may, going beyond the budgetary expectations, the pharmaceutical industry in India should keep focusing on good corporate governance. This encompasses adherence to high ethical standards in clinical trials and in promotion of medicines, regulatory and legal compliance, being harsh on corrupt practices, addressing all issues that support good healthcare policies of the Government and takes care of the healthcare needs of the common man through inclusive business growth.

It is obvious that the Pharmaceutical Industry alone will have a limited role to play to address all the healthcare issues of the country. Important stakeholders like the Government, Corporates and the civil society in general must contribute according to their respective abilities, obligations and enlightened societal interests, towards this direction.

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.

Does the Indian Patents Act conform to Article 27 (Patentable Subject Matter) of TRIPS on the issue of ‘local working of patents’?

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India is one of the signatories of TRIPS and has a national commitment on adherence to this important international agreement. It is, therefore, widely believed that the amended Indian Patents Act will be TRIPS compliant.

A recent circular from CGPTD:

Recently, the Controller General of Patents, Trademarks and Designs (CGPTD) of India through a circular dated December 24, 2009, directed all Patentees and Licensees to furnish information in ‘Form No.27’ on ‘Local Working of Patents’ as prescribed under Section 146 of the Patents Act., Although this directive is again a statutory requirement, nevertheless it has given rise to many speculations in several quarters as to whether ‘importation’ of products patented in India, will be considered as ‘local working of patents’ or not.

The Last date for filing the information is March 31, 2010. Only history will tell us about the possible future impact of this notification.

What does Article 27.1 say in this regard?

The Article 27.1 of TRIPS, for which India is a signatory, indicates as follows on ‘local working of patents’:

“1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.”

Thus as per Article 27.1 of TRIPS, if commercialization of a product patented in India, is done in India whether through imports or local manufacturing, will be considered as ‘local working of patents’.

Does Section 83 B of the Indian Patents Act conform to Article 27.1 of TRIPS?
One observes, despite Article 27.1 of TRIPS agreement, section 83 (General principles applicable to working of patented inventions) of the Indian patents Act says the following:

“(b) that they (patents) are not granted merely to enable patentees to enjoy monopoly for the importation of the patented article.”

Thus the questions that will need to be answered now are as follows:
i. Does Section 83.b conform to TRIPS 27.1?

ii. If yes, how?

iii. If not, does it merit an amendment?

iv. If the issue goes for litigation, what could the Indian High Courts likely to interpret as ‘local working of patents’?

Could it give rise to any possibility to trigger ‘Compulsory Licensing (CL)’?

For ‘Compulsory Licensing’, Section 84 of the Indian Patents Act indicates the following:

“At any time after expiration of three years from the date of the grant of patent, any person interested may make an application to the Controller for grant of compulsory license on patent on ANY of the following grounds namely:

(a) that the reasonable requirements of the public with respect to the patented invention has not been satisfied, or

(b) that the patented invention is not available to the public at a reasonable affordable price, or

(c) that the patented invention is not worked in the territory of India”

Once again, the answer to yet another question that all concerned will be interested to know is as follows:

i. What could possibly be the determinants for the India Patent Office (IPO) or High Courts to interpret, “available to the public at a reasonable affordable price?”

Conclusion:

If these two sets of questions could find conclusive answers, much of the speculations, which are now floating around on what could the information provided through ‘Form 27’ be used or misused by the interested parties, to revoke a patent on the grounds of ‘local working’ or trigger a CL under Section 84.

In my personal view establishing either of these two grounds to the IPO to derive sheer commercial benefits, could indeed be a daunting task for any interested party.

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.

Indian Patent offices (IPOs) have started showing improvement in their functioning; still lot of grounds to cover.

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Indian Patent offices are located, with four clearly specified jurisdictions, at New Delhi, Mumbai, Kolkata and Chennai.

Since last few years enough efforts have been made towards overall capacity building initiatives, training of personnel and digitalizing the huge databank of these offices, with wide scale application of information technology (IT). As a result the patent offices are now having almost a centralized database to provide online services to the users in various areas of their operations. Users are now having the facilities of not only online patent search, but also for online patent applications.

More extensive IT applications are required to achieve greater system efficiency and transparency:

However, to bring in more efficiency and transparency in the system, there is a need to introduce appropriate IT applications in all the transactional interfaces between the patent office personnel and the patent applicants.

Still there are lots of grounds to cover:

Following are the key areas which should be taken care of by the Controller General of Patents, Design and Trade marks (CGPDTM) to make the IPOs more efficient, transparent and effective:

1. The Patent Manual, which provides essential guidelines to the patent examiners to bring in uniformity in the patent application examination process, is long overdue.

2. Many patent applicants feel that there is a need to include the International Non-proprietary Names (INN) in the title of pharmaceutical patent applications by the IPO.

3. Inadequate bandwidth makes the IT system slow, reducing its operational efficiency.

4. Electronic-filing of patent applications has been introduced, but there is no facility of paying the fees online by credit card. This facility should be introduced to make it more convenient for applicants to file patent applications online, adding more speed to the process.

5. Electronic prosecution of patent applications should be introduced to make the patent prosecution virtually paperless and more efficient.

6. Despite new technological measures most patent officers and also the public in general are still following the traditional method of filing the patent applications due to the ease and authenticity of filing records. To encourage applicants to file applications electronically, incentives such as reduced fees may be offered to those who file their applications electronically.

7. The IPOs should digitize all the physical files lying with them, so that file histories of each application are available online.

8. The Patent offices should have designated centres to provide assistance to applicants for filing or prosecuting applications.

9. Clear guidelines to be issued for conducting pre-grant and post grant opposition proceedings. Presently they are being handled in an arbitrary manner.

10. In order to introduce an efficient system of patent prosecution, it is recommended that the IPOs adjust patent term to compensate patentees for any delay in the grant of the patent that reduces the term of the patent, when such delay is caused solely by the IPOs.

11. Decision making and its communication to all concerned to be made faster at the IPOs. A system to be instituted for issuing the operative part of the decision first, followed by details of the decision taken. These should be advertised immediately in the technical journal to close proceedings at the earliest. Delays are leading to increase in the waiting period for the grant of patents, even if the proceedings have been concluded (opposition or otherwise) attracting serial and frivolous pre-grant oppositions. Such delays are also preventing the patent applicants to get their grants. As a result they are unable to initiate infringement proceedings against infringers quickly, defeating the very purpose of the patent system.

12. The timeline for an application, which will be taken up for examination, needs to be clearly defined. Currently, there is no time-line defined for taking up the applications for examination.

Conclusion:

All concerned will feel happy, if the DIPP in general and the CGPDTM in particular take note of these suggestions and formalize a process within the IPOs to address these important issues.

Growing discontentment of the past, in several areas of operation within the IPOs, is now being effectively addressed. However, the system still warrants more capacity building to enable the IPOs provide world class services to the patent applicants. This process needs to be expedited to further enhance the credibility of the new IPR regime in 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.

To prevent ‘counterfeit medicines’ from reaching the patients is the nation’s public health responsibility: Are we still in a denial mode to even accept the existence of this public health menace?

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In November 7, 2009, Financial Express reported with a headline,”Generic drug companies see a bitter pill in counterfeit“, because some believe that it has an in-built intellectual property right connotation.
The dictionary definition:

The word ‘counterfeit’ may be defined as follows:

1. To make a copy of, usually with the intent to defraud

2. To carry on a deception; dissemble

4. To make fraudulent copies of something valuable

5. A fraudulent imitation.

What does Indian Drugs and Cosmetics Act say?

May be for this reason the Drugs and cosmetics Act of India has specified that manufacturing or selling of the following types of drugs are punishable offence:

Section 17: Misbranded drugs

Section 17-A: Adulterated drugs

Section 17-B: Spurious drugs

No one has asked, so far, that as misbranding could involve trademark and design, why should it fall under Drugs and Cosmetics Act?

This was done in the past by the law makers because they believed that any attempt to deliberately and fraudulently pass off any drug as something, which it really is not, could create a serious public health issue, leading to even death.

Be that as it may, the pharmaceutical industry all over the world sincerely believes that counterfeit drugs involve heinous crime against humanity.

Definition of counterfeit drugs should cover the all types of medicines, which are not genuine:

Definition of counterfeit drugs should, therefore, cover the entire gamut of medicines, which are not genuine. Such medicines could be a fraudulent version of patented, generic or even traditional medicines and have nothing to do with patents or patent infringements.

At the same time it sounds very reasonable that a medicine that is authorized for marketing by the regulatory authority of one country but not by another country, should not be regarded as counterfeit on this particular ground in the other country, if it is not made available fraudulently.

The recent survey on ‘spurious’ and ‘sub-standard’ drugs by the Government of India:

To assess the magnitude of the menace of counterfeit drugs, Financial Express dated November 12, 2009 reported that much hyped “world’s largest study on counterfeit drugs” conducted by the Ministry of Health of the Government of India with the help of the Drug Controller General of India’s office, has come to the following two key conclusions:

1. Only 0.0046% of the drugs in the market were spurious

2. Quantum of sub-standard drugs in India is just 0.001%

From this report, it appears that India, at this stage, has nothing to worry about this public health hazard!!!
It is indeed quite baffling to understand, why did the government keep ‘misbranded drugs’, as specified in the Drugs and Cosmetics Act of India, outside the purview of this study.

Be that as it may, it appears that this survey has raised more questions than what it had attempted to answer. Such questions are expected to be raised not only by the pharmaceutical industry of India, its stakeholders and the civil society at large, but by the global experts, as well.

The problem of counterfeit is more prevalent in countries where regulatory enforcement is weak:

The menace of counterfeit medicines is not restricted to the developing countries like, India. It is seen in the developed countries, as well, but at a much smaller scale. Thus it is generally believed that the issue of counterfeit drugs is more common in those countries, where the regulatory enforcement mechanism is weak.

A study done by IMPACT in 2006 indicates that in countries like, the USA, EU, Japan, Australia, Canada and New Zealand, the problem is less than 1%. On the other hand, in the developing nations like parts of Asia, Latin America and Africa more than 30% of the medicines are counterfeits.

The role of ‘The World health Organization (WHO):

To effectively root out this global menace, the leadership role of the WHO is extremely important. Across the world, patients’ need protection from the growing menace of counterfeit medicines. As a premier organization to address the needs of the global public health issues and especially for the developing world, the WHO needs to play a key and much more proactive role in this matter.

Conclusion:

All stakeholders of the pharmaceutical industry must be made aware more effectively, without further delay, of the health threats posed by counterfeit medicines. Authorities and organizations like the Drug Controller General of India (DCGI) and its regulatory and enforcement agencies, healthcare professionals, patients, all pharmaceutical manufacturers, drug distributors, wholesalers and retailers should collaborate to play a very active and meaningful role in curbing the counterfeit drugs from reaching the innocent patients.

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

Will mandatory disclosure of ‘payments to physicians’ by the pharmaceutical companies be an overall part of “Healthcare reform process” in the US and what about India?

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The brief Scenario in India:
In India over 20, 000 pharmaceutical companies of varying size and scale of operations are currently operating. It is alleged that lack of regulatory scrutiny is prompting many of these companies to adapt to ‘free-for-all’ types of aggressive sales promotion and cut-throat marketing warfare involving significant ‘wasteful’ expenditures. Such practices involve almost all types of their customer groups, excepting perhaps the ultimate consumer, the patients.

Unfortunately in India there is no single regulatory agency, which is accountable to take care of the healthcare needs of the patients and their well being.

The pharmaceutical industry of India, in general, has expressed the need to self-regulate itself effectively, in the absence of any regulatory compulsion. However, many activists groups and NGOs feel that the bottom-line in this scenario is the demonstrable transparency by the pharmaceutical companies in their dealings with various customer groups, especially the physicians.

The brief scenario in the US:

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.

As the financial relationship between the pharmaceutical companies and the physicians are getting increasingly dragged into a raging 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 mandatory by the Obama administration, as a part of the new US healthcare reform process.

As I said in my earlier article, 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 pharma 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.

In the meantime, Cleveland Clinic and the medical school of the University of Pennsylvania, US are 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.

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, along with its much discussed new healthcare reform process.

If President Obama’s administration takes such regulatory steps will Dr. Manmohan Singh government prefer to stay much behind?

I shall try to explore that emerging scenario in my next blog post.

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.

Provision for Compulsory Licensing (CL) in India – some issues still need to be addressed.

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Patent law systems provide for a provision for granting of compulsory licenses in a number of circumstances. Article 5A(2) of The Paris Convention, 1883 indicates that each contracting State may take legislative measures for the grant of compulsory licenses and reads as follows:“Each country of the Union shall have the right to take legislative measures providing for the grant of compulsory licenses to prevent the abuses which might result from the exercise of the exclusive rights conferred by the patent, for example, failure to work.”TRIPS agreement also contains important public health safeguards provisions to allow countries to override TRIPS requirements by engaging in compulsory licensing under certain situations and circumstances. Globally all patent systems comply with the requirements of TRIPS.

Doha declaration:

Doha Declaration gives WTO member-countries the right to grant compulsory licences (CL) and the right to decide on the reasons upon which such licences are to be granted. The declaration also states that the TRIPS Agreement should be interpreted and implemented by the member-countries in a manner to protect public health and to promote access to medicines for all.

“Safeguards provision” in India:

The Indian Patent Act 2005 bestows enough power to the Controller General of Patents, Trademarks and Designs of India to issue compulsory licenses (CL) under following different sections of the Act:

1. Section 84:

This section prevents the abuse of patent as a monopoly and states that at any time after the expiration of three years from the date of grant of a patent, any interested person may make an application to the Indian Patent Office (IPO) for grant of compulsory licence on any of the following grounds:

(a) That the reasonable requirements of the public with respect to the patented invention have not been satisfied, or

(b) That the patented invention is not available to the public at a reasonably affordable price, or

(c) That the patented invention is not worked in the territory of India

Section 6 of section 84 states that in considering the application filed under this section, the controller shall take into account the following:

(i) The nature of the invention, the time which has elapsed since the sealing of the patent and the measures already taken by the patent or licensee to make full use of the invention;

(ii) The ability of the applicant to work the invention to the public advantage;

(iii) The capacity of the applicant to undertake the risk in providing capital and working the invention, if the application is granted;

(iv) Whether the applicant has made efforts to obtain a license from the patentee on reasonable terms and conditions and such efforts have not been successful within a reasonable period as the Controller may deem fit:

Provided that this clause shall not be applicable in case of national emergencies or other circumstances of extreme urgency or in case of public non-commercial use or on establishment of a ground of anti-competitive practices adopted by the patentee.

Terms and conditions of CL will be determined by the Controller under section 90.

2. Sections 92 (1) and 92 (3):

These sections enable the Central Government to deal with circumstances of national emergency or circumstance of extreme urgency or in case of public non-commercial use by issuing CL.

3. Section 92 A:

This part enables grant of CL for export of patented pharmaceutical products in certain exceptional circumstances to any country having insufficient or no manufacturing capacity for the concerned product to address public health problems.

Some loose knots:

Some believe that there are still some loose knots in the CL provisions in India, which need to be tightened, immediately.

Granting CL for a Biopharmaceutical product could be an issue:

It will not be very easy to grant CL for a biopharmaceutical product as the conditions in which biopharmaceuticals are produced largely define the final product and its manufacturing process defines the product quality. Any alteration to the manufacturing process may result in a completely different product.

Therefore following are the main issues, which need to be urgently addressed:

• Small changes in the manufacture of biopharmaceutical and biosimilar medicinal products can dramatically affect the safety and efficacy of the therapeutic molecule.

• The very nature of a biologic means that it is practically impossible for two different manufacturers to manufacture two identical biopharmaceuticals if identical host expression systems, processes and equivalent technologies are not used. This has to be demonstrated in an extensive comparability program. Therefore a generic biopharmaceutical cannot possibly exist.

• Substitution issues:

By contrasts with the situation applicable for generic chemical entities, biosimilar medicines can be “similar” but not “identical” to the innovator reference products. The “similar, but not identical” nature of biosimilar medicines means that substitution of the innovator product with a biosimilar product could have clinical consequences as patients could respond differently to the two products. To guarantee the efficacy and safety of biosimilar products, these products should only be approved following the submission of appropriate data generated with the biosimilar drug.

• Currently there are no published clear Indian guidelines for the approval of biosimilar drugs which will ensure the approval of efficacious and safe biosimilar drugs.

Some apprehensions on CL in India need to be addressed:

Some apprehensions have been expressed on possible misuse of CL and representations made to the government to address the following issues urgently. Tarceva and Stutent cases involving Nepal will probably justify such apprehensions:

o As the entire concept is based on “Working of Patents” in India, the term “Working of Patents” needs to be defined explicitly.

o Issuance of CL to be restricted to national emergency, extreme urgency and public non-commercial use

o Provisions in (Sec. 84 [7]) needs to be suitably amended that provide grounds for triggering CL by competitors for commercial benefits.

o Safeguards enshrined in the Aug 30 decision (Motta-Menon text) is to be provided for exports under Section 92A of the Indian Patents Act 2005, corresponding to Para 6 of the declaration on the TRIPS Agreement

Is paying royalty to patent holder an acceptable solution to this issue?

Many feel that this question totally ignores the right of an innovator to protect his/her innovation, which is the outcome of a painstaking, long, costly and risky R&D process. Such protection is granted to an innovator against disclosure of the data generated for the innovation to the patent office for public knowledge at large through grant of a patent for a specific time period. During this period the innovator is the exclusive owner of the innovation. The provision of CL can be invoked during this period, as stated above, for some very specific and extra-ordinary situation.

Such extra-ordinary situation, as and when will arise be addressed by the government based purely on the merits of the cases. Carte blanche permission by any authority allowing use of an innovator’s product during its patent life against a royalty payment, without innovators wish, is believed to be against the letter and spirit of Indian Patents Act 2005.

Conclusion:

In Indian Patents Act 2005, the provisions of CL should maintain a fine balance between the critical need of innovation by the pharmaceutical companies and its reach to the users to meet their unmet needs. For a country like India, CL is probably the most appropriate safeguard against potential abuse of monopoly by the patentees in case of national emergencies and to address critical public health issues.

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.