In the Pharmaceutical Space: The Dragon breathes fire

Currently both China and India, the two most populous nations of the world are also the front runners of the global economy in terms of the pace of GDP growth. The economies of the two countries are greatly influenced by their respective sociopolitical environment. However, the economy of China is more robust ranking second in the world, against eleven of India. The dragon is indeed breathing fire.

A comparison of the economy of the two countries, as reported by ‘MapsofIndia.com’ updated in July 2011, is as follows:

Facts India China
GDP US$1.31 trillion US$ 4.90 trillion
GDP growth 8.90% 9.60%
Per capital GDP US$1124 US$7,518
Inflation 7.48 % 5.1%
Labor Force 467 million 813.5 million
Unemployment 9.4 % 4.20 %
Fiscal Deficit 5.5% 21.5%
Foreign Direct Investment US$12.40 billion US$9.7 billion
Gold Reserves 15% 11%
Foreign Exchange Reserves US$2.41 billion US$2.65 trillion
World Prosperity Index 88th Position 58th Position
Mobile Users 842 million 687.71 million
Internet Users 123.16 million 81 million.

Global pharmaceutical ranking:

As reported by IMS, in global ranking, China was ninth largest pharmaceutical market against thirteenth of India in 2004, became  fifth largest in 2009 against thirteenth of India and is expected to be the third largest by 2014 against tenth of India, growing at a much faster pace.

2004 Rank

2009 Rank

2014 Rank

1 United States 1 United States 1 United States
2 Japan 2 Japan 2 Japan
3 France 3 Germany 3 China
4 Germany 4 France 4 Germany
5 Italy 5 China 5 France
6 United Kingdom 6 Italy 6 Brazil
7 Canada 7 Canada 7 Italy
8 Spain 8 Spain 8 Canada
9 China 9 United Kingdom 9 Spain
10 Brazil 10 Brazil 10 India
11 Mexico 11 Russia 11 Russia
12 Australia 12 Mexico 12 United Kingdom
13 South Korea 13 India 13 Venezuela
14 India 14 Australia 14 Turkey
15 Netherlands 15 Turkey 15 South Korea

Source: IMS Health MIDAS, Market Prognosis September 2010; Market size ranking in constant US$

Healthcare coverage:

In China, out of a population of 1.3 billion, 250 million are covered by health insurance, another 250 million are partially covered by insurance and balance 800 million are not covered by any insurance.

Against these statistics of China, in India total number of population who have some sort of healthcare financing coverage will be around 200 million and penetration of health insurance will be just around 3.1% of the population. India is fast losing grounds to China in this respect mainly due to better response to healthcare infrastructure and regulatory challenges by China.

Commitment to globalization:

A very high level of commitment of the Chinese Government to make China a regional global hub for pharmaceutical R&D and contract research and manufacturing (CRAM) activities within next seven to ten years is now paying rich dividends.

Department of Pharmaceuticals (DoP) of the Government of India (GoI) also expressed its intention to make India a R&D hub in not too distant future. Unfortunately, this cannot be achieved with just good intent of investments of couple of million US$ through Public Private Partnership (PPP) initiatives, as announced by the DoP earlier.

A strong commitment of the GoI to hasten regulatory reform processes with visible action will be the deciding success factor. IPR regime in the pharmaceutical industry has been put in place, but an appropriate to foster innovation in the country is yet to be created.

Healthcare Infrastructure:

Korn/Ferry International has reported that China’s infrastructure in the pharmaceutical space is better than India, primarily due to firm commitment of the Chinese government to accelerate reform measures to fetch maximum benefits of globalization process in the country.

It has been reported that China has not only better healthcare infrastructure as compared to India, but they are also more open  to of foreign trade and investments to improve these further in their country.

R&D Comparison:

Talent Pool and no. of Patents granted:

According to WIPO, China has better R&D talent pool and grants more patent per year than India as follows:

India

China

R&D Talent Pool

45,000

56,000

Patents Granted (2008-09)*

16,061

48,814

*Patent Granrted in India during 2009-10:6168

Source: FE Bureau / WIPO / IPO

Scientific Publications:

India also lags behind China in the number of scientific publications as follows:

Pre 2000 (A)

Post 2000 (B)

B/A*

India 3,04,737 4,98,394 1.64
China 2,30,154 19,94,706 8.67

*Multiple of Post-2000 over Pre 2000

Between pre-2000 and post-2000 era, China’s count of scientific publications rose more than eight times compared to India’s 1.6 times. (Source: Search on Scopus Sciverse (Database from Elsevier)

Based on ‘WIPO PCT’ applications, it has been reported that 5.5% of all global pharmaceutical patent applications named one inventor or more located in India as against 8.4% located in China.

Biology Research:

China is taking faster strides in the Biology Research area as follows:

INDIA

CHINA

  1. Only about five companies with proven skills in basic molecular biology and protein expression

2. Innovative research focused on bioinformatics and bio-chips

3. Limited biology talent pool owing to historic focus on generics1. Established skills in basic molecular biology and protein expression

2. Innovative research in stem cells, bio-chips, and gene sequencing

3. Expanding biology talent pool

(Source: BCG report, Looking Eastward)

Clinical trials:

In the area of clinical trial, though by amending  the Schedule Y of the Drugs and Cosmetics Act in line with ICH GCP, India has already put in place the Good Clinical Practices (GCP), China has, on the other hand, brought its GCP, GLP, and GMP standards in line with ICH guidelines.

May be because of all these reasons ‘A.T. Kearney’ in its ‘Country Attractiveness Index’ (CAI) for clinical trials has given 6.10 to China against 5.58 to India.

BCG compared India with China in the Clinical Trial space as follows:

INDIA

CHINA

1. Experienced CROs with full service range and output of similar quality to that of developed markets.

3. Limited FDA approved hospitals

4. Shorter trial approval times than in China

5.Uneven infrastructure and shortage of clinical research assistants

  1. Experienced CROs and growing vendor pool providing full spectrum of services
  2. High quality FDA-approved hospitals
  3. Low-cost and efficient enrollment compared to the US and Europe
  4. Trial approvals lengthy and complex

(Source: BCG report, Looking Eastward)

Despite all these, both India and China pose challenges to both global and the local pharmaceutical players in dealing with subjects of wide cultural diversity within the country besides illiteracy and poverty. Many cases of conflict between ethics and natural justice have been reported from both countries during recruiting process of the subjects for clinical trial.

Pharmaceutical outsourcing:

In terms of attractiveness for outsourcing among the emerging pharmaceutical markets of the world, India and China are outpacing others with their cutting edge offering of high quality services at lower cost together with large pool of skilled manpower.

India has the potential to be a contender of supremacy for Pharmaceutical outsourcing of all types with all the required success ingredients. However, putting these ingredients together for effective use to make it happen has indeed become a real challenge.

On the other hand China is racing ahead to effectively avail the global opportunities and in that process fast distancing itself from India, widening the competitive performance gap between the two countries. Brain drain:

Korn/Ferry International has reported that more and more Indian talent is being pulled to China to fill key roles, especially in the API sector, signaling ‘brain drain’ from India to China.

Where India is a high flier:

Chemistry Research:

India is globally considered as a more mature place for chemistry related drug-discovery activities than China. Probably, because of this reason, companies like, Aurigene, Advinus, Divis Lab and Jubilant Organosys could enter into long-term collaborative arrangements with Multinational Companies (MNC) to discover and develop New Chemical Entities (NCEs).

BCG report, ‘Looking Eastward’ compared India with China in the Chemistry Research area as follows:

INDIA

CHINA

  1. Large pool of vendors with full services and track record of strong capabilities

2. Generally better IP protection than in China

3. Trend toward project based alliances and emerging build-operate-transfer (BOT) contracts

4. Vast pool of skilled and low cost chemists

  1. Capabilities residing mostly with government institutes; only a few small private companies with a track record
  2. Established basic chemistry skills moving to more complex offerings, but no end to end capabilities
  3. Large and growing pool of raw talent, but limited English language skills still an issue

(Source: BCG report, Looking Eastward)

Earlier reform in China: It is important to mention that healthcare reform process started much earlier in China. The Product Patent regime in India was reintroduced in January 1, 2005. Well before that time China started creating and encouraging a large number of independently funded pharmaceutical R&D institutions to create an environment of innovation within the country. Many of these institutions are now viable profit centers, creating wealth for the country.

At the same time, focusing on economies of scale, Chinese pharmaceutical players have now become globally competitive, may be a shade better than India. Clear dominance of China in the business of ‘Active Pharmaceutical Ingredient (API)’ among many others, will vindicate this point.

On other hand in the formulations business, India is miles ahead of China, catering to over 20 percent of global requirements for the generic pharmaceuticals. Even in ANDA and DMF filings, India is currently ahead of China. 

Conclusion:

While comparing India with China one should also take into consideration that not only the sociopolitical structure of India and China are quite different, but the difference exists also in their commerce and industry related political decision making process.

Moreover, the average age of Chinese population is much more than Indians and continues to increase rapidly. The factor of aging population may have an adverse impact on the overall productivity of their people in the coming years constraining the economic growth of China. In contrast, the percentage of young working people in India is expected to keep increasing through 2030, offering a very critical  demographic advantage to the country in the years ahead.

Though China will continue to have aging population and India the younger ones, both countries will have to deploy greater resources to cater to the growing healthcare needs for altogether different reasons. The net gainer will indeed be the pharmaceutical industry in both the countries.

That said, just a wishful thinking of the Government of India, sans expeditious and prudent regulatory and other related policy reforms, will helplessly make India watching the gap between the pharmaceutical industry of the two countries fast widening, making the dragon keep breathing fire, unabated.

By: Tapan J 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 New Drug Policy is languishing in a labyrinth

Drug Price Control has remained the key feature of all Drug Policies of India, since their inception in early 70’s. Most of these policies continued to remain behind their times consistently, without any exception.

That said, the Drug Policy 1994 and the consequent Drug Price Control Order 1995 (DPCO  ’95) have now become the largest ‘Dinosaur’ of all Drug Policies. However, the most intriguing point though, both these have still been kept operational by the government and the very concept of a new and a more contemporary one is languishing in a labyrinth since over a decade, for reasons of anybody’s guess.

Drug Price Control system in India:

It appears that the drug price control system in India is here to stay, at least in the short to medium term and that too in a seemingly best case scenario.

The key reasons:

As we know, the key reasons of price control for pharmaceuticals in India are the following:

  • To contain cost of medicines, particularly the essential ones, at a reasonably affordable level, which is a very important part of the total healthcare expenditure of the common man.
  • To provide greater access to medicines to all, especially in view of very high  ‘out of pocket expenditure’ for health for a vast majority of population in the country.

The economic factors:

Some of the economic factors, which may cause impediments in achieving these objectives are the following:

  • Sub optimal public healthcare infrastructure, leaky delivery system and high cost of  private healthcare services
  • This is fueled by, as stated above, unabated increase in ‘out-of-pocket expenses’ on healthcare in general and medicines in particular at 78 per cent, as compared to 61 per cent in China, 53 per cent in Sri Lanka, 31 percent in Thailand, 29 per cent in Bhutan and 14 per cent in Maldives (Source: The Lancet)
  • High expenses on drugs for outpatient care

Though very important, drug cost alone, however, does not determine quality of access to healthcare.

Global scenario for drug price control:

As per published reports, all 34 developed nations of the world have ‘Universal Health Coverage’ mechanism in place in various different forms, including mandatory medical insurance requirements, to effectively address the issue of high access to healthcare including pharmaceuticals in their respective countries, significantly reducing ‘out of pocket expenses’ towards health.

All these 34 countries belong to ‘Organization for Economic Co-operation and Development (OECD)’, the governments of which, in some way or the other control and regulate drug prices.

The Governments/payors of most of these countries implement the price control measures by playing the role of a dominant market force directly, while negotiating a favorable price from the manufacturers, which are much lower than their equivalent free market prices.

Many other OECD governments set the drug reimbursement prices right at the time of introduction of new drugs through hard negotiation, which are also well below free market prices and acts as the bench mark market prices, in many ways.

In addition to all these mechanisms, the governments in many OECD countries periodically reduce the prices of already marketed drugs quite significantly.

A contrarian view on Drug Price Control:

Some industry experts feel that there is a hidden consequence for the ‘Drug Price Control System’, especially with the cost based one.

The cost based price control as is currently practiced by the government in India compels the pharmaceutical manufacturers to restrict to:

  • Minimum acceptable quality standard rather than maximum possible quality standards for the patients
  • Does not encourage innovation in formulation development like novel galenic formulations for better patient acceptance and compliance
  • Indirectly discourage innovation in product packaging
  • Ceiling Price mechanism does not encourage advanced anti-counterfeit measures for patients’ safety

These experts also feel that adverse consequences of price control will have a significant negative impact on the pharmaceutical players to plough back fund towards R&D projects to meet the unmet needs of the patients and thereby reducing the range of treatments that could be made available to the patients in the years ahead.

What is China doing?

On March 28, 2011 Reuters reported that China had cut the maximum retail price for more than 1,200 types of antibiotics and the drugs for the circulatory system by an average of 21 percent.

It has also been reported that the Chinese Government has put a cap on the prices of about 300 drugs featuring in their ‘National List of Essential Medicines (NLEM).’

Supreme Court directive on ‘Price Control’ of ‘Essential Medicines’:

It is worth noting in this context that in 2003, the Supreme Court of India, while setting aside the Drug Policy 2002 directed the government to work out effective mechanism to bring all essential and life-saving medicines under price control.

HLEG recommends ‘Price Control’ of ‘Essential Medicines’:

Even in its report the ‘High Level Expert Group (HLEG)’ on ‘Universal Health Coverage (UHC)’ in India, set up by the Planning Commission of India under the chairmanship of the well-known medical professional Prof. K. Srinath Reddy, under recommendation no. 3.5.1, postulated price control and price regulation on essential drugs, which is quite in line with the draft National Pharmaceutical Pricing Policy 2011 (NPPP 2011).

The HLEG report says:

“We recommend the use of ‘essentiality’ as a criterion and applying price controls on formulations rather than basic drugs. Direct price control applied to formulations, rather than basic drugs, is likely to minimize intra-industry distortion in transactions and prevent a substantial rise in drug prices. It may also be necessary to consider caps on trade margins to rein in drug prices while ensuring reasonable returns to manufacturers and distributors. All therapeutic products should be covered and producers should be prevented from circumventing controls by creating nonstandard combinations. This would also discourage producers from moving away from controlled to non-controlled drugs. At the same time, it is necessary to strengthen Central and State regulatory agencies to effectively perform quality and price control functions.”

Types of drug price regulations in India:

  1. Cost based price control: e.g. as specified in the Drug Price Control Order 1995 (DPCO 95)
  2. Marked based price control: e.g. as was suggested by ‘The Pronab Sen Committee’ in 2005
  3. Price Monitoring with a cap on annual price increase: e.g. as is currently followed by the National Pharmaceutical Pricing Authority (NPPA) for all products which are outside DPCO ’95

The weaknesses of cost based pricing mechanism:

The key criticism of cost based pricing mechanism flows from the following arguments:

  • This system is not followed by any developed or developing countries worth mentioning, which follow drug price control mechanism in any form
  • A Complex, intrusive and inefficient system of pricing medicines
  • Does not consider important variations in the level of GMP standards and the quality of input costs
  • The conversion cost and packing norms are determined through a sample survey of less than one per cent of pharmaceutical manufacturing units

Pronab Sen Committee report – the basis of price control in the draft NPPP 2011:

The draft NPPP 2011 is based on the ‘Recommendations of the Task Force constituted under the Chairmanship of Dr. Pronab Sen to explore issues beyond Price Control to make available Life-saving Drugs at reasonable prices’ to all.

‘Pronab Sen Committee’ suggested the following principles of Price regulation to achieve part of the above objective:

1.       The National List of Essential Medicines (NLEM) should form the basis of drugs to be considered for intensive price monitoring, ceiling prices and for imposition of price controls, if necessary.

2.       The government should announce the ceiling price of the drugs contained in the NLEM (other than the drugs procured by hospitals directly and which an individual does not have to purchase from the market) on the basis of the weighted average prices of the top three brands by value of single ingredient formulations prevailing in the market as on 01.04.2005. In cases where there are less than three brands, the weighted average of all the existing brands would be taken. The Org–IMS data set can be used for this purpose initially with a 20 per cent retail margin provided. There is, however, a need to improve the available data coverage, which should be taken up with ORG-IMS or any other data provider.

3.       For drugs which are not reflected in ORG-IMS data, the NPPA should prepare the necessary information based on market data collection.

4.       During the transition period (i.e. till the time ceiling prices are fixed and notified) prices of all essential drugs may be frozen.

5.       The Government should specify the reference product in terms of strength and pack size for each product which would form the basis for price determination. The price ceiling would be specified on a per dosage basis, such as per tablet/per capsule or standard volume of injection. Where syrups and liquids are sold in bottles the ceiling price may be fixed on individual pack size.

6.       Price relaxations may be permitted for non-standard delivery systems, packaging and pack sizes through applications to the negotiations committee, which should become applicable for all similar cases.

7.       In the case of formulations which involve a combination of more than one drug in the NLEM, the ceiling price would be the weighted average of the applicable ceiling prices of its constituents.

8.       For formulations containing a combination of a drug in the NLEM and any other drug, the ceiling price applicable to the essential drug would be made applicable. However, the company would be free to approach the price negotiations committee for a relaxation of the price on the basis of evidence proving superior therapeutic effectiveness for particular disease conditions.

9.       In order to determine the reasonableness of the ceiling prices fixed as above, the prices quoted in bulk procurement by Government and other designated agencies may be examined for use, provided that the system of bulk procurement meets certain minimum prescribed standards. Recognizing that retail distribution has costs not reflected in bulk procurement, a markup of 100 per cent over this reference price is recommended.

10.    NPPA should set up a computer based system which would scan the price data provided by companies against the ceiling prices determined as above and identify formulations which breach the relevant price ceiling. The company manufacturing or marketing such a product would be required to reduce its price or to face penal action.

11.    Companies should be permitted to represent for any price increase on valid grounds, which should then become applicable to the entire class of products.

12.   The NLEM should be revised periodically, say every 5 years, in order to reflect new drugs and significant changes in pattern of drug sales within the therapeutic categories. However till the time the new list is finalized the existing list will continue to be valid for the purpose of price control.

13.   In the case of drugs not contained in the NLEM, intensive monitoring should be carried out of all drugs falling into a pre-specified list of therapeutic categories. Any significant variation in the prices (say above 10 per cent) would be identified for negotiation.

The stakeholders’ comments on NPPP 2011:

About 60 stakeholders have commented by now on the draft NPPP 2011. The views are quite divergent though. It is interesting to note that the new draft pricing policy, in its current form, has been rejected by all key stakeholders, like the Industry, Ministry of Health, Expert Groups, WHO, NGOs and reportedly even by the Economic Advisory Council of the Prime Minister, on quite different grounds.

As widely reported in the media, the pharmaceutical industry, though in favor of the marked based pricing  mechanism, feels that the draft NPPP 2011 will increase the span of drug price control to over 60 per cent of the Indian Pharmaceutical Market (IPM). This means over eight times increase in the span of price control from its current level, making the task unwieldy for even the NPPA.

Majority of other stakeholders including the Ministry of Health, on the contrary, are arguing in favor of cost based price control. They commented that the price control system of the draft policy would give legitimacy to high drug prices in India, leading to increase in the overall prices of medicines. This group feels that the top three brands in majority of cases will be the most expensive ones.

Two interesting observations by the World Health Organization (WHO) on ‘Trade Margin’:

The WHO  in their observations on the draft NPPP 2011 has made the following interesting comments:

  1. “The new price regulation uses a margin of16% to calculate the retail prices. This is a lower margin than currently – based on the market data 1.1 and 3.3 I calculated a current retail margin of 22%. So the new price regulation implies a margin reduction of 6%, alternatively the CP might be set at a 6% lower price than currently is the case.”

If the WHO observation is correct, there is a scope to reduce the price of essential medicines by 6 per cent only through proper regulation of the trade margin.

  1. WHO also comments that IMS data, the basis of all such calculations by the NPPA, has severe limitations as “Their data does not take into account the discounts, rebates and bundling deals and when the data is collected at the level of the wholesaler they estimate the retailer and patient prices”.

If such is the case, what could possibly be the basis of all calculations as captured in the draft NPPP 2011? 

Observation of a distinguished Parliamentarian: 

Dr. Jyoti Mirdha , a Member of the Lower House of the Parliament (Lok Sabha) commented as follows:

“Under this policy the weighted average of three top selling brands will be the ceiling price. There is no logic in restricting the formula to just three brands. Why not five? Why not 10 to arrive at a more representative and reasonable figure? Besides why base on sales figures? In any pricing policy the parameter should be the price. Why not weighted average of 10 least priced brands?”

This could well be a pertinent question.

How to break the logjam now?

Taking on from Dr. Mirdha’s argument , WHO observations and Pronab Sen Committee report, one could possibly try to resolve this logjam by exploring various other available alternatives like for example, the following broad points, to ascertain whether a win-win situation can be created for all through the new drug policy:

  1. What happens if ‘Weighted Average Price’ is calculated based on all brands, instead of top three or bottom three with some exclusion criteria, if required?
  2. When inclusion criteria for price control in the new draft NPPP 2011 is ‘essentiality’ of drugs, it sounds logical that price control should be restricted to National List of Essential Medicines 2011 (NLEM 2011). Only possible extension could perhaps be taking the entire molecule, instead of specified strengths of the same molecule.
  3. Enough non-price control checks and balances to be put in place to ensure proper availability of NLEM 2011 drugs to the common man and avoidance of any possible situation of shortages for such drugs.
  4. As commented by WHO, trade margin should be rationalized, the MRP needs to be reduced accordingly and the consequential benefits to be passed on to the patients.

Conclusion:

The issue of the new National Pharmaceutical Pricing Policy should be resolved sooner than later and that too by conforming to the directive given by the Supreme Court on essential medicines. At the same time, all the stakeholders must feel comfortable with the new drug policy.

The four points, as mentioned above, are just an illustration for choosing an alternative solution. If it works, let us move on. If it does not, let us search for the pathfinder who can break the decade old labyrinth rather quickly, without losing the way yet again.

However, the bottom-line remains that the solution should be a win-win one, both for the patients and the industry alike, benefiting the healthcare space of the country in the years ahead.

By: Tapan J 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.

Grant of Compulsory License for Bayer’s Nexavar in India raises more questions than answers

On March 12, 2012, the Patent Office of India, in its landmark ruling, granted its first ever Compulsory License (CL) for Bayer’s patented kidney and liver cancer drug Nexavar (Sorafenib), to the generic pharma player Natco, broadly citing the following reasons:

  • Reasonable requirements of public under Section 84 have not been satisfied.
  • The Patented Drug was not available to the public at a reasonably affordable price as per Section 84 (1) (b).
  • Patented invention is not worked in the territory of India as per Section 84 (1) (c)

The 62 page order of the Controller General of Patents, Designs and Trade Mark (CGPDTM) granted the CL to Natco for the rest of patent life of sorafenib in India at the high end of the UNDP 2001 royalty guidelines at 6 percent.

Sorafenib:

Sorafenib was co-developed and co-marketed by Bayer and Onyx Pharmaceuticals  for the treatment of advanced  renal cell and hepatocellular carcinoma. The drug got its first regulatory approval from the US FDA for advanced renal cell carcinoma in 2005.

National Institute of Health and Clinical Excellence (NICE) of UK had indicated that the drug extends life of the kidney cancer patients by three months on an average.

As stated earlier, in March 2008, Indian patent for Sorafenib was granted to Bayer by the CGPDTM. Thereafter, in December 2010 Natco had requested for a voluntary license from Bayer, which was rejected by the patentee.

It has been reported that sorafenib was registered as an ‘orphan drug’ in the US. The R&D cost of sorafenib was partly subsidized by the US Orphan Drug tax credit.

Mixed reaction:

Though the research based pharmaceutical industry across the world expressed its disappointment over the judgment, many experts and NGOs from different parts of the globe have opined that CGPDTM has set a right precedence by granting a CL for sorafenib, which will ensure, in the times to come, that patent monopolies are kept limited, especially when the patented products are not “reasonably affordable”.

Many people, therefore, envisage that the grant of the first ever CL by the Indian Patent Office could ultimately open the door for other generics players of India to apply for the same on similar grounds and mainly for ‘non-working of patents’, as many patented medicines are now imported into India by the respective global players.

Granting CL should be the last resort:

While none can deny that all citizens of India should have access to innovative and lifesaving medicines, as will be required for their medical treatment, it appears rather impractical to envisage that routine issue of CL by the Indian Patent Office will be able to resolve this critical issue on a long term basis.  Grant of CL, if any, I reckon, should be taken only after exhausting all other access improvement measures.

Working of a patent:

In this particular case, it has been decided by the CGPDTM that working of a patent will require the concerned company to manufacture the drug in India in a reasonable quantity. The argument of the CGPDTM in this respect, many experts believe, is quite a stretch of an interpretation of the statute.

This is mainly because, as one of the signatories of TRIPS, India has a national commitment for adherence to this important international agreement. It is, therefore, widely believed, if importation is not considered as working of patent, the country could expose itself to the risk of  violation of the Article 27.1 of TRIPS, both in letter and spirit.

The Article 27.1 of TRIPS:

The Article 27.1 of TRIPS on ‘local working of patents’ indicates as follows:

“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 products patented in India, is done locally either through imports or local manufacturing, should be considered as ‘local working of patents’.

Form 27 vindicates the fact:

Form 27 of the Indian Patents Act, which is a statement regarding the working of patented inventions on commercial scale in India, in its point number 3, under ‘if worked’ states as follows:

“If worked: quantum and value (in Rupees) of the patented product:

  1. Manufactured in India
  2. Imported from other countries (give country-wise details)”

Thus, when Form 27 itself accepts importation as ‘local working of patent’, it is indeed intriguing why was the decision to the contrary taken by the CGPDTM?

Moreover, it is worth noting that the term ‘manufacture in India’ was deleted from the earlier Section 90 (a) of the Patents Act.

A statutory requirement:

CGPDTM 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.

It will be interesting to know, whether CGPDTM in response to Form 27 submissions of Bayer had informed them earlier that the Nexavar Patent has not been worked in India. If not, what is then the sanctity of Form 27 filing?

Delhi High Court Judgment:

Further, it has been well reported that in the legal case of ‘Telemecanique & Controls (I) Limited Vs. Schneider Electric Industries SA 94(2001)DLT865’ on working of patents, the Delhi High Court had concluded that importation would amount to working of Patents.

India specific pricing for innovative drugs is not uncommon:

At this stage, it is worth mentioning that India specific pricing for innovative drugs are not uncommon in the country at all. Following are some good examples:

  • GlaxoSmithKline  Pharmaceuticals has already announced its differential pricing system for India and will sell its innovative drugs at prices 25% to 40% less than what those are in the US.
  • MSD  has already introduced its India specific price for patented products. Their patented cervical cancer drug Gardasil is being sold in India at 75% -80% less than the global prices.
  • Moreover, MSD’s patented anti-diabetic drug Januvia (sitagliptin phosphate) is locally sourced and marketed at one-tenth of the global price.
  • In 2008 Novartis  reportedly tied up with the domestic pharma major USV to market its patented anti-diabetic drug Galvus (Vildagliptin) by pricing it lower than Januvia. According to reports, Novartis markets Galvus in the metros, while USV markets the same brand in tier two and three cities of India.
  • Roche  has recently collaborated with the domestic pharma player Emcure Pharmaceuticals to manufacture its two well-known biologics Herceptin and MabThera not only to cater to the domestic needs, but also for export to other developing markets.

Manufacturing of a small quantity locally – an issue:

As quoted in the order of the CGPDTM there are around 8842 eligible patients for sorafenib in India. All these patients put together will require Nexavar ranging from 27000 (Bayer’s figure) to 70000 boxes (NATCO’s figure) per year.  Thus, the moot question remains: even for such small annual requirements, should global companies set up manufacturing facilities in all the countries like, India.

Another question: if other smaller markets of the world also make local manufacturing mandatory for any pharmaceutical products that will be sold in their respective countries, will the Indian players find those markets attractive enough to expand their business? In that case who will be the net losers?… Patients?

Conclusion:

If the issue of whether importation will be considered as ‘local working of patents’ or not is not answered conclusively under higher judicial scrutiny in conformity of Article 27.1 of TRIPS and CL is granted to local manufacturers for commercial benefits under similar situation, availability of life saving innovative products in the Indian market for the patients of India could be in a real jeopardy.

The objective of improving access to innovative medicines is a very desirable one for any country like ours. However, if India routinely starts granting CL for this purpose before exhausting all other avenues to achieve this goal, it would risk sending a very wrong signal to the outside world that the country is shirking its responsibilities to create an appropriate ecosystem to foster and support pharmaceutical innovation to offer better quality of lives to the citizens of the country in particular.

In the absence of both collaboration and foreign direct investments by the global innovators in the field of pharmaceutical research and development, India may feel handicapped, especially when our neighbor China is surging ahead in this field with longer strides.

Thus, routine grant of CL, as is being envisaged by many in India, on a similar situation could, on the contrary, make the issue of access to innovative medicines by the common man even more challenging, in the longer run.

By: Tapan J 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.

Healthcare Industry of India: Being catapulted from a labyrinth to an accelerated growth trajectory

As reported by the ‘World Health Statistics 2011′, India spends around 4.2 percent of its Gross Domestic Product (GDP) on health, which is quite comparable with other BRIC countries like, China and Russia.This has been possible mainly due to increasing participation of the private players in the healthcare sector.

The following table will highlight this point:

Health Expenditure:

Type Brazil Russia India China
Exp. on Health (% of GDP)

8.4

4.8

4.2

4.3

Govt. Exp. on Health  (% of Total Exp. on Health)

44

64.3

32.4

47.3

Pvt. Exp. on Health      (% of Total Exp. on Health)

56

35.7

67.6

52.7

Govt. Exp. on Health    (% of Total Govt. Exp.)

6

9.2

4.4

10.3

Social Security Exp. on Health (% of General Govt. Exp. on Health)

-

38.7

17.2

66.3

However, the following healthcare indicators suggest quite clearly that the total expenditure on healthcare by a country is not always directly proportional to its health outcome. This holds good for many countries across the world, including the USA, as the overall healthcare system  and more importantly its cost effective delivery mechanism are the key determinants of success:

Health Indicators:

Type Brazil Russia India China
Life Expectancy at birth

73

68

65

74

Neonatal Mortality Rate  (Per 1000)

12

06

34

11

Infant  Mortality Rate MDG 4  (Per 1000)

17

11

50

17

Maternal   Mortality Rate MDG 5(Per 1000,000 birth)

58

39

230

38

Source: World Health Statistics 2011

Fueled by the increasing participation of private players, coupled with a hefty hike in public expenditure on health to 2.5 percent of GDP during the 12th Five Year Plan Period, the Indian healthcare sector, currently at US$ 65 billion, is expected to reach US$ 100 billion by 2015 (Source: Fitch), increasing the total spend of the country on health to around 6.8 percent of GDP during this period.

The expenditure towards healthcare infrastructure is expected to grow by 50 percent from its 2006 number to reach US$ 14.2 billion in 2013, as reported by KPMG.

Growth Drivers:

The key growth drivers are expected to be as follows:

  • A hefty hike in Government expenditure as a percentage to GDP for health
  • 1% of the growing population coming above the poverty line every year
  • Growing middle class population
  • Increasing incidence of non-infectious chronic illnesses and other life style diseases
  • Reasonable  treatment costs due to intense competition and government intervention on health related issues
  • Large public healthcare projects like, National Rural Health Mission (NRHM), National Urban Health Mission (NUHM), ‘Universal Health Coverage’, distribution of free medicines through Government hospitals
  • Expansion of Rashtriya Swasthya Bima Yojana (RSBY)
  • Increasing penetration of private health insurance
  • Increasing direct procurement of medicines both by the Central and also the State Governments
  • A boom in medical tourism

The basic Challenge:

Following areas will throw a tough challenge for a sustainable growth in healthcare:

  • To reach a doctor population ratio of 1 doctor and 2.3 nurses per 1000 population by 2025 from the current 0.06 doctors and 1.3 nurses.
  • To reach a ratio of 2 beds per 1000 population by 2025 from the current 1 bed, which means India would require creating additional 1.75 million beds by that time.
  • An investment of US$ 86 billion will be needed to achieve 1 doctor, 2 beds and 2.3 nurses per 1000 population by 2025
  • Although the health insurance had a penetration to a meager 2.3 percent of the population in 2007, the sector is expected to cover just around 20 percent of the population by 2015 (Source: ICRA).

Key Developments:

  • As per the Rural Health Survey Report 2009 of the Ministry of Health, the rural healthcare sector in the country is registering an appreciable growth with the addition of the following during the last five years:

-     15,000 health sub-centers

-     20, 107 primary health centers

-     28,000 nurses and midwives

  • According to a report by research firm RNCOS, the health insurance premium is expected to grow at a CAGR of over 25 per cent from 2009-10 to 2013-14.
  • India will curve out a share of 3 percent of the global medical tourism industry (Source:RNCOS)
  • Medical technology industry of India is expected to reach US$ 14 billion by 2020 from US$ 2.7 billion in 2008, according to a report by PwC.
  • E-healthcare in rural areas is gaining popularity with the involvement of both public and private players like, ISRO, Mazumdar Shaw Cancer Center and Narayana Hrudayalaya. Some telecom companies like, Nokia and BlackBerry are also contemplating to extend the use of mobile phones for remote disease monitoring as well as diagnostic and treatment support. Introduction of 3G and in the near future 4G telecom services will further enhance opportunities of e-healthcare through mobile phones.
  • Expansion of major healthcare players in tier-II and tier-III cities of India like, Apollo, Narayana Hrudayalaya, Max Hospitals, Aravind Eye Hospitals and Fortis will help improving access to affordable healthcare in the smaller places, significantly.

Examples of expansion in smaller places:

According E&Y report of November 2010, following key players are expanding their presence in tier II and tier III cities, besides metro and tier I cities:

Company No. Of beds

Presence

Apollo Hospitals Enterprise Ltd 8,500 Chennai, Madurai, Hyderabad, Karur, Karim Nagar, Mysore, Visakhapatnam, Bilaspur, Aragonda, Kakindada, Bengaluru, Delhi, Noida, Kolkata, Ahmedabad, (Mauritius), Pune, Raichur, Ranipet, Ranchi, Ludhiana, Indore, Bhubaneswar, (Dhaka, Bangladesh)
Aarvind Eye Hospitals 3,649 Theni, Tirunelveli, Coimbatore, Puducherry, Madurai, Amethi, Kolkata
CARE Hospitals 1,400 Hyderabad, Vijaywada, Nagpur, Raipur, Bhubaneshwar, Surat, Pune, Visakhapatnam
Fortis Healthcare Ltd 5,044 Mumbai, Bengaluru, Kolkata, Mohali, Noida, Delhi, Amristar, Raipur, Jaipur, Chennai, Kota
Max Hospitals 800 Delhi and NCR
Manipal Group of Hospitals +7,000 Udupi, Bengaluru, Manipal, Attavar, Mangalore, Goa, Tumkur, Vijaywada, Kasaragod, Visakhapatnam

Source: E&Y, November 2010

Healthcare sector is attracting FDI:According to the Department of Industrial Policy & Promotion (DIPP), the healthcare sector is undergoing significant transformation and attracting investments not only from within the country but also from overseas.The Cumulative FDI inflow in the healthcare sector from April 2000 to November 2011, as per DIPP publications, is as follows:

Sector FDI inflow (US$ million)
Hospital and diagnostic centers 1100
Medical and surgical appliances 472.6
Drugs and pharmaceuticals 5,033

(Source: Fact Sheet on FDI (April 2000 to November 2011), DIPP)

Government Policy:

Government has also started focusing on increasing investments towards creation of a sustainable medical infrastructure, especially in the rural areas. The following policy initiatives could help facilitating this process:

  • 100 per cent FDI for health and medical services.
  • Allocation of US$ 10.15 billion to the National Rural Health Mission (NHRM) for upgradation and capacity building of rural healthcare facilities.
  • Allocation of US$ 1.23 billion to create six AIIMS type medical institutes and upgradation of 13 existing Government Medical Colleges.

Overseas players started participating:

BCG Group will open shortly a multidisciplinary health mall that would provide a one-stop solution for all healthcare needs starting from doctors, hospitals, ayurvedic centers, pharmacies including insurance referral units at Palarivattom in Kochi, Kerala. BCG’s long-term plan, as reported in the media, is to set up a health village spanning across an area of a 750,000 sq. ft. with an estimated cost of US$ 88.91 million.

Along the same line, to set up more facilities for diagnostic services in India, GE Healthcare reportedly has planned to invest US$ 50 million for this purpose.

Examples of initiatives by State Governments:

In southern India, the Government of Andhra Pradesh has implemented a Health Management Project funded by the Department for International Development (DFID) of the UK costing US$ 59.68 million. It has been reported that many other State Governments of India are planning to go for similar Health Management models in their respective States.

Improving access to modern medicines in India:

Ten year CAGR in terms of volume of the domestic pharmaceutical industry has been around 15 percent, which clearly signals significant increase in the consumption of medicines, leading to their improving access to the general population of both rural and urban India.

Extension of focus of the Indian pharmaceutical Industry, in general, to the fast growing rural markets further vindicates this point.

The rate of increase in access to medicines may not be directly commensurate to the volume growth of the industry during this period, but a major part of the industry growth could certainly be attributed towards increasing access to medicines in India, which should cover over 60% of the population of the country, by now.

Unfortunately, even the Government of India does not seem to be aware of this gradually improving trend of access to medicines in the country. Official communications of the government still quote the outdated statistics of 1998 (published in 2004), which states that 65% of the population of India does not have ‘Access to Modern Medicines’ even today. No wonder, why many of us still prefer to live on to our past.

Conclusion:

Be that as it may, around 40% of the population still does not seem to have adequate ‘Access to Medicines’ in India. This issue though attracted attention of the policy makers, has still remained mostly unresolved and needs to be addressed following a holistic approach with the newer plans.

A robust model of healthcare financing for all socioeconomic strata of the society with plans  like, ‘Universal Health Coverage’ and continuous improvement of healthcare infrastructure and   delivery systems, as are now being planned by the astute brain trusts of India, are expected to bring significant reform in the healthcare space of India.

Let us also note at the same time that all these are happening, despite shrill voices of naysayer vested interests, continuously projecting to many of us a stagnant, dismal and never improving healthcare scenario of the country, more often than not.

Very fortunately, from an unenviable labyrinth, healthcare industry of India, at last, seems to be on the threshold of being catapulted to a higher growth trajectory riding on a decent number of both public and private initiatives, never than ever before.

Unless it is so, why will the healthcare players from across the world keep on increasing their operational focus, in every way, on India and China?

By: Tapan J 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 Vaccine Market of India: A rejuvenation is in progress

Even in couple of decades back, ‘Vaccines Market’ in India did not use to be considered as a focus area by many pharmaceutical companies. Commoditization of this market with low profit margin and unpredictable interest of the government/the doctors towards immunization were the main reasons. Large global players like Glaxo exited the vaccine market at that time by withdrawing products like, Tetanus Toxoid, Triple Antigen and other vaccines from the market.

Currently, the above scenario is fast changing. The vaccine market is getting rejuvenated not only with the National Immunization Program (NIP) of the country, but also with the emergence of newer domestic vaccines players and introduction of novel vaccines by the global players, which we shall discuss below.

In addition, the ‘Indian Academy of Pediatrics (IAP) Committee on Immunization’ now recommends the ‘best individual practices schedule’ for the children in consultation with their respective parents. Such schedule may not conform to NIP and include newer vaccines, broadening the scope of use of vaccines in general.

Global Market:

According to GBI Research Report, overall global vaccines market was valued at US$ 28 billion in 2010 and is expected to reach US$ 56.7 billion by 2017 with a CAGR of 11.5%. The key growth driver of this segment will be introduction of newer vaccines, which are currently either in the regulatory filing stage or in the late stages of clinical development.

The important international players in the vaccines market are GlaxoSmithKline, Sanofi, Pfizer, Novartis AG, Merck and SP-MSD, representing around 88% of the total vaccine segment globally.

Indian Market:

Year

Value

   Rs. Cr.

Growth  %

2007

389

-

2008

383

-2

2009

476

24

2010

726

53

Source: IMS – Health MAT June 2010

India is one of largest markets for all types of vaccines in the world. The growth is being driven by the new generation and combination vaccines, like DPT with Hepatitis B, Hepatitis A and Injectable polio vaccine. The demand for veterinary vaccines is also showing ascending trend. Pediatric vaccines contribute to around 60% of the total vaccines market in India.

McKinsey in its report titled, “India Pharma 2020: Propelling access and acceptance, realizing true potential“ stated that at 2% penetration, the vaccines market of India is significantly under-penetrated with an estimated turnover of around US$ 250 million, where the private segment accounts for two-thirds of the total. McKinsey expects the market to grow to US$ 1.7 billion by 2020.

In India companies like, Serum Institute, Shantha Biotecnics, Bharat Biotech and Panacea Biotech are poised to take greater strides in this direction. Bharat Biotech is incidentally the largest Hepatitis B vaccine producer in the world. Likewise, Serum Institute is reportedly one of the largest suppliers of vaccines to over a 130 countries of the world and claim that ’1 out of every 2 children immunized worldwide gets at least one vaccine produced by Serum Institute.’

Indian Vaccine Market:  Domestic vs MNCs:

In the domestic vaccine market the market share of the Indian players is gradually improving as compared to their multinational counterparts.

Types

June 2009 MAT

% Value Growth

June 2010 MAT

% Value Growth

Indian Companies

55%

27

59%

64

MNCs

45%

21

41%

38

Source IMS-Health – June 2010 MAT

Indian Vaccine Market: Top 10 Companies:

Rank

Company

Value     (Rs. Cr)

%Market Share

%Value Growth

Vaccine Market

726

100

53

1

GSK

131

18

23

2

Sanofi Aventis

129

18

>>

3

Pfizer

71

10

75

4

Novartis

68

9

-12

5

Serum Institute

68

9

40

6

Panacea Biotech

59

8

57

7

VHB Lifesciences

33

5

>>

8

Zydus Cadila

32

4

56

9

MSD

31

4

>>

10

Shantha Biotech

24

3

15

Source IMS-Health – June 2010 MAT

Indian Vaccine Market: Top Therapies:

Therapies

Value

     (Rs.Cr.)

%Market Share

% Value Growth

Incr. Value          (Rs. Cr)

June’09 MAT

June’10 MAT

June’09 MAT

June’10 MAT

Vaccine Market

726.1

100

24

53

93

250

Toddler Vaccine

211

29

55

60

47

79

Adult Vaccine

205

28

-4

22

-7

37

Paediatric Combination Vaccines

146

20

67

>>

28

77

Paediatric Single Vaccines

131

18

25

32

20

32

All Other Vaccines

33

5

431

6

27

Source IMS-Health – June 2010 MAT

Indian Vaccine Market: Top 10 Brands:

Rank

Brands

Company

Value

       (Rs.Cr.)

Value Growth %

Incr. value   

(Rs. Cr.)

June’09 Mat

June’10 MAT

June’09 Mat

June’10 MAT

Vaccine Market

726

24

53

93.1

250

1 Prevenar Pfizer

71

150

75

24

30

2 Rabipur Novartis

68

4

-12

3

-9

3 Pentaxim Sanofi Aventis

46

>>

>>

7

39

4 Havrix GSK

37

9

47

2

12

5 Varivax VHB

33

59

>>

5

18

6 Vaxirab Zydus Cadila

32

-11

56

-3

11

7 Varil Rix GSK

25

-3

-9

-1

-2

8) Gardasil MSD

22

—-

>>

5

16

9 Verorab Sanofi Aventis

21

—-

—-

0

21

10 Rotarix GSK

21

—-

>>

10

11

Source: IMS-Health – June 2010 MAT

Indian Vaccine Market: Top 10 New Introductions:

NIs

Company

Launch Date

Value

(Rs. Cr)

Incr. Value

(Rs. Cr)

Vaccine Market

104

79

Gardasil MSD 10/2008

22

16

Rotarix GSK 07/2008

21

11

Pentavac Serum Institute 10/2008

16

12

Cervarix GSK 02/2009

11

10

Polprotec Panacea Biotech 07/2008

9

6

Xprab Ranbaxy 10/2009

7

7

Quadrovax Serum Institute 11/2008

4

3

Comvac- 5 Bharat Biotech 02/2009

3

3

Pentavac – SD Serum Institute 11/2009

2

2

Shan HIB- DPT Shantha Biotech 09/2008

2

1

Source:IMS-Health – June 2010 MAT

Action areas to boost growth:

McKinsey in its above report ‘India Pharma 2020’ indicated that the action in the following 4 areas by the vaccine players will drive the vaccine market growth in India:

  • Companies need to go for local production of vaccines or leverage supply partnerships. GlaxoSmithKline’s local partnership for the HiB vaccine with Bio-manguinhos in Brazil has been cited as an example.
  • Companies will need to conduct studies on the economic impact of vaccination and establish vaccine safety and performance standards.
  • Extension of vaccine coverage beyond pediatricians and inclusion of general practitioners, consulting physicians and gynaecologists will be essential.
  • Companies will need to enhance supply chain reliability and reduce costs.

Conclusions:

On January 7, 2012, while requesting the ‘Overseas Indian Medical Professionals’ to partner with the institutions in India, the Health Minister, in his address, announced that the Ministry of Health has already introduced the second dose of measles vaccine and Hepatitis-B vaccination across the country. Moreover, from December, 2011 a ‘Pentavalent Vaccine’ has been introduced, initially in 2 States, covering 1.5 million children of India.

All these augur quite well for the country. However, keeping in view of the humongous disease burden of India, immunization program with various types of vaccines should receive active encouragement from the government as disease prevention initiatives, at least, keeping the future generation in mind.

If such policy measures are initiated in the country, without delay, the domestic vaccine market , in turn, will receive further growth momentum, together with newer players and modern vaccines coming in, to help addressing effectively a significant area of the healthcare concerns of the country.

By: Tapan J 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.

Healthcare Tourism: India needs to step on the gas

Healthcare Tourism or Medical Tourism are the terminologies initially coined by the travel agents and the media when patients travel outside their national boundaries to seek either more specialized and/or cheaper but high quality healthcare available in other countries.

World Health Organization (WHO) defines Healthcare Tourism as an activity that covers:

  • Medical care
  • Sickness & well-being
  • Rehabilitation & recuperation

The reasons:

The main reasons of healthcare tourism are:

  1. High medical costs, especially for those patients who are under-insured or uninsured
  2. Long waiting period for elective surgery
  3. To avail technologically more advanced medical treatment and care

For example, USA though globally recognized as one of the technologically most advanced countries in providing high quality healthcare to the patients, the cost of comprehensive healthcare in the country is often beyond reach of many Americans.

In not too distant past (2000), the World Health Organization (WHO) ranked USA as the country with most expensive healthcare systems in the world. Moreover, it has also been reported that in the US, the fees paid to doctors for medical services are usually much higher for an ‘uninsured’ patient than one who is ‘insured’.

Such a scenario has given rise to situation where many Americans travel out of the country for a lower cost medical care, if not adequately insured.

‘Time Health’ in an article titled ‘A Brief History of Medical Tourism’ stated as follows:

-       In 2006: 150,000 US citizens underwent medical treatment abroad

-       In 2007: the number grew to an estimated 750,000

-       In 2008: it increased to 1.3 million

-       In 2010: the figure further swelled to an estimated 6 million citizens.

The article commented that “Patients are packing suitcases and boarding planes for everything from face lifts to heart bypasses to fertility treatments.”

The key influencers and preferred destinations:

The most common influencer for healthcare tourism globally, as stated earlier, is lack of or inadequate health insurance and the most common emerging destinations for healthcare tourism in the world are Thailand, Singapore, Costa Rica, Panama, Brazil, Mexico, Malaysia and India. This is mainly because of fact that the costs of availing high quality healthcare services in these countries are much cheaper- on an average around 80%. For example, a cardiac surgery, which will cost more than US$ 50,000 in the US, can be availed for US$ 20,000 in Singapore, US$ 12,000 in Thailand and between US$ 3,000 and US$ 10,000 in India.

Other factors influencing Healthcare Tourism, particularly in India, besides significant cost advantages, are:

  1. High quality treatment and hospital stay with world class medical technological support
  2. Rigid compliance with international treatment standards
  3. No language barrier with the western world
  4. Government taking active steps and interest in the medical tourism sector

In all these four areas significant advantages that India offers will need to be adequately leveraged in a sustainable manner by the country.

Most popular treatment areas:

The most popular treatment areas are as follows:

  1. Alternative medicines
  2. IVF treatment
  3. Bone-marrow transplant
  4. Cardiac bypass
  5. Eye surgery
  6. Dental care
  7. Cosmetic surgery
  8. Other areas of advanced medicine

Evolving scenario:

Since last several years healthcare tourism is fast evolving as one of the key growth drivers of the global healthcare sector as a whole.

Dr. Fred Hansen in his article titled, ‘A Revolution in Healthcare’, highlighted that increasing number of high-quality healthcare facilities in the developing coun­tries are attracting medical tourists from the developed countries like the US and the European Union (EU).

Apprehension in the US about growing Healthcare Tourism of India:

India Knowledge@Wharton in its June 2, 2011 issue reported as under:

  • In the past, US President Barack Obama had singled out India for what he sees as the country usurping American jobs and business.
  • In May 2009, he removed some tax incentives for US companies who allegedly preferred to outsource rather than create domestic jobs. “Buffalo before Bangalore” was his rallying call at the time.
  • In April 2011, he told a town hall gathering in Virginia that Americans shouldn’t have to go to India or Mexico for “cheap” health care. “I would like you to get it right here in the U.S.,” he said.
  • In January 2012, President Obama reiterated the same intent in the run up to the forthcoming US presidential election for his second term.

The Global Market:

In 2006 the global market for healthcare tourism was around US$ 60 billion. According to McKinsey & Company, this market is expected to expand to over US$110 billion by 2012.

India – a contender for supremacy:

Healthcare tourism in India, despite being smaller compared to the western world, is surging ahead both at the national and the regional levels with enormous potential for future growth, if explored appropriately with a carefully charted strategic game plan in its evolution process.

Currently India is emerging as one of the preferred destinations for global health tourists. The country received 150,000 medical tourists in 2004, which grew by 33% to 200,000 in 2008, mainly from the USA, UK and the Gulf countries, primarily due to low-priced and high quality healthcare in wide ranging disease areas. More and more people from these countries are finding the prospect of high quality and value added medical care in India financially attractive.  As per estimates, India will receive over 500,000 medical tourists per year come 2015.

While visiting India for healthcare, patients not only get treated by the best medical professionals with western medical training, but also are able to stay in deluxe accommodations fully equipped with the latest television set, refrigerator and in some cases even a personal computer, without facing any language barrier and that too by paying just around 1/10th of the price charged in the developed nations.

Moreover, according to John Lancaster of ‘The Washington Post’ (October 21, 2004) Indian private hospitals have a better mortality rate for heart surgery than American hospitals.

With over 8,500 beds ‘Apollo Hospitals’ chain runs 53 different hospitals across the country, followed by “Max Healthcare” that runs 8 medical centers in the National Capital Region (NCR) in India.

Indian Market:

Economic Times, in its January 6, 2009 edition reported, “Indian medical tourism to touch Rs 9,500 Crore (around US $ 2.1 billion) by 2015”.  Another report titled “Booming Medical Tourism in India”, published in December 2010 estimated that the medical tourism industry will generate revenues of around US$ 3 billion by 2013, though with a market share of just around 3% of the of global healthcare tourism industry.  Thus, in healthcare tourism, India still remains a smaller player with enormous growth potential.

New job creation:

Both Public and private sector studies estimate that healthcare tourism in India could attract around US$ 3 billion to the country by 2013 with around 40 million direct and indirect job opportunities.

Cost advantage in India:

Cost Comparison: India vs UK:

Nature of Treatment

Treatment Approximate Cost in India ($) *

Cost in other Major Healthcare Destination ($) *

Approximate Waiting Periods in USA / UK    (in months)

Open heart Surgery

4,500

> 18,000

9 – 11

Cranio-facial Surgery and skull base

4,300

> 13,000

6 – 8

Neuro-surgery with Hypothermia

6,500

> 21,000

12 – 14

Complex spine surgery with implants

4,300

> 13,000

9 – 11

Simple Spine surgery

2,100

> 6,500

9 – 11

Simple Brain Tumor -Biopsy -Surgery

1,000 4,300

> 4,300 > 10,000

6 – 8

Parkinson -Lesion -DBS

2,100 17,000

> 6,500 > 26,000

9 – 11

Hip Replacement

4,300

> 13,000

9 – 11

* These costs are an average and may not be the actual cost to be incurred.

(Source: Health Line)

The key components:

The following four basic components constitute the healthcare tourism industry: • Healthcare Providers: Hospitals, mainly corporate hospitals and doctors • Payers: Medical/ Health insurance companies • Pharmaceutical Companies: for high quality affordable medicines • IT Companies: operating in the healthcare space

Growth drivers and barriers:

Following are the key growth drivers:

  1. Government support through policies and initiatives
  2. High quality, yet low cost care
  3. Much less or no waiting time
  4. World class private healthcare infrastructure
  5. Rich source of natural and traditional medicines. Ministry of Tourism is  promoting the traditional systems of medicines, like,  Ayurveda, Siddha, and Yoga to project India as a the destination of choice for spiritual wellness and healing

In future, the world class and low cost private sector healthcare services are expected to drive the growth of the medical tourism in India.

However, any shortages in the talent pool and inadequacy in other basic infrastructural support like roads, airports and power could pose to be barriers to growth of this sector, if not addressed immediately.

Government Assistance:

The government of India is now supporting the hospitals to get the Joint Commission International (JCI) accreditation.

In 2009 the government announced a revised guidelines for ‘Marketing Development Assistance (MDA)’ scheme for approved Medical Tourism service providers like, representatives of hospitals accredited by Joint Commission for International Accredited Hospitals (JCI) and National Accreditation Board of Hospitals (NABH) and Medical Tourism facilitators (Travel Agents/Tour Operators approved by Ministry of Tourism, Government of India and engaged in Medical Tourism (MTSP) and to the approved Wellness Centers i.e. representatives of the Wellness Centers accredited by the State Governments.

All these measures are expected to accelerate the growth of healthcare Tourism industry in India.

List of JCI Accredited Hospitals in India:

Following are the JCI Accredited Hospitals in India till 2007:

Name and Place Accredited on
1. Indraprasta Apollo Hospital, New Delhi June 18, 2005
2. Wockhardt Hospital, Mumbai August 25, 2005
3. Apollo Hospitals, Chennai January 29, 2006Disease- or Condition-Specific Care (DCSC)Certification for Acute Stroke: 29 April 2006
4. Shroff Eye Hospital, Mumbai February 18, 2006
5. Apollo Hospitals, Hyderabad April 28, 2006
6. Asian Heart Institute, Mumbai October 20, 2006
7. Satguru Pratap Singh Apollo Hospital, Punjab February 3, 2007
8. Fortis Hospital, Mohali June 15, 2007

Source: Joint Commission International, 2007

The challenges:

Following are the key challenges that India will need to address to emerge as a healthcare tourism hub of the world:

  • Improving the infrastructure
  • Adequate training of the staff
  • Enhancement of the image of India as a corruption-free country
  • Continuous improvement of overall service to the patients

Conclusion:

While encountering the global economic meltdown many corporate business houses, even in the developed nations of the world, are under a serious cost containment pressure, which includes medical expenses for their employees. Such cost pressure has already started prompting many companies to send their employees to low cost destinations for treatment, without compromising on the quality of their healthcare needs. This trend could offer an additional growth opportunity in the healthcare tourism sector in India.

According to the ‘Medical Tourism Climate Survey 2010’ report, the leading medical tourism destinations are currently India, Thailand, Hungary and Malaysia and the leading source of patients being again the USA, UK and Russian Federation.

The survey rates Thailand, India and Singapore as the best in terms of quality of overall patients’ care. Insurance and liability issues for the patients from some major markets of the world could pose to be a challenge for speedy growth of this industry.

Countries like, Thailand, Singapore and Malaysia, located in quite closer proximity to India, will continue to offer a tough competition in the healthcare tourism space of the country.

In an increasingly heated-up fast evolving competitive scenario, the name of the game for India will be to ‘step on the gas’, sooner and effectively.

By: Tapan J 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.

Encourage vaccine research and improve its access to demonstrate ‘prevention is better than cure’

Vaccines are one of the most successful and cost-effective public health interventions, which help preventing over 2 million deaths every year.

The World Health Organization (WHO) defines vaccines as:

“A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. Vaccines include, for example, suspensions of killed or attenuated microorganisms, or products or derivatives of microorganisms. The most common method of administering vaccines is by injection, but some are given by mouth or nasal spray.”

Types of Vaccines:

As per the ‘National Institute of Health (NIH)’ of USA, following are some types of vaccines that researchers usually work on:

  • Live, attenuated vaccines
  • Inactivated vaccines
  • Subunit vaccines
  • Toxoid vaccines
  • Conjugate vaccines
  • DNA vaccines
  • Recombinant vector vaccines

The first vaccine:

In 1796, Edward Anthony Jenner not only discovered the process of vaccination, alongside developed the first vaccine of the world for mankind – smallpox vaccine. To develop this vaccine Jenner acted upon the observation that milkmaids who caught the cowpox virus did not catch smallpox.

As per published data prior to his discovery the mortality rate for smallpox was as high as up to 35%. Thus, Jenner is very often referred to as the “Father of Immunology”, whose pioneering work has “saved more lives than the work of any other person.”

Later on in 1901 Emil Von Behring received the first Nobel Prize (ever) for discovering Diphtheria serum therapy.

The future scope of vaccines:

The future scope of vaccines is immense as several potentially preventable diseases, as indicated below remain still unaddressed.

Examples of effective Vaccines Examples of Potentially VaccineTreatable Diseases
Bacterial
  • Diphtheria
  • Haemophilus influenza type B
  • Meningitis A, C
  • Pneumococcus
  • Enterococcus
  • Meningitis B, W, Y
  • Group A Streptococcus
  • Staphylococcus
Viral
  • Varicella
  • Hepatitis B and C
  • Influenza
  • Polio
  • Pandemic influenza
  • RSV
  • West Nile Virus
  • Epstein Barr Virus
Other
  • Cancer
  • Alzheimer’s disease
  • Substance abuse
  • Autoimmune disorders

Source: Deutsche Bank Report 

Expanded focus for vaccines:

The focus of the global vaccine industry also has been expanded from prophylactic vaccination for communicable disease (e.g. DTP vaccine) to therapeutic vaccines (e.g. Anti-cancer vaccines) and then possibly non-communicable disease vaccines (e.g. vaccines for coronary artery disease).

The Issues and Challenges:

To produce a safe and effective marketable vaccine, it takes reportedly around 12 to 15 years of painstaking research and development process involving an investment ranging between US $500 million and over $1 billion dollars (Ibid, 7).

Moreover, one will need to realize that the actual cost of vaccines will always go much beyond their R&D expenses. This is mainly because of dedicated and highly specialized manufacturing facilities required for mass-scale production of vaccines and then for the distribution of the same mostly using cold-chains.

Around 60% of the production costs for vaccines are fixed in nature (National Health Policy Forum. 25. January 2006:14). Thus such products will need to have a decent market size to be profitable.

Unlike many other medications for chronic ailments, which need to be taken for a long duration, vaccines are administered for a limited number of times, restricting their business potential.

Thus, the long lead time required for the ‘mind to market’ process for vaccine development together with high cost involved in their clinical trials/marketing approval process, special bulk/institutional purchase price and limited demand through retail outlets, restrict the research and development initiatives for vaccines, unlike many other pharmaceutical products.

Besides, even the newer vaccines will be required mostly for the diseases of the poor, like Malaria, Tuberculosis, HIV and ‘Non Communicable Diseases (NCDs)’ in the developing countries, which may not necessarily guarantee a decent return on investments for vaccines, unlike many other newer drugs. As a result, the key issue for developing a right type of newer vaccine will continue to be a matter of pure economics.

A great initiative called GAVI: 

Around 23 million children of the developing countries are still denied of important and life-saving vaccines, which otherwise come rather easily to the children of the developed nations of the world.

To resolve this inequity in January 2000, the Global Alliance for Vaccines and Immunization (GAVI) was formed. This initiative was mainly aimed at generating sufficient fund to ensure availability of vaccines for children living in the 70 poorest countries of the world.

The GAVI Alliance has been instrumental in improving access to six common infant vaccines, including those for hepatitis B and yellow fever. GAVI is also working to introduce pneumococcal, rotavirus, human papilloma virus, meningococcal, rubella and typhoid vaccines in not too distant future.

A recent example:

As if to vindicate the above points, Reuters on December 16, 2011 reported that  “Pfizer and GlaxoSmithKline are increasing sales of cut-price pneumonia vaccine to developing countries by more than 50 percent, marking the scale-up of an international program to protect millions of children.

GAVI is buying an additional 180 million doses of Pfizer’s pneumococcal vaccine Prevenar 13 and a similar quantity of GSK’s Synflorix at a deeply discounted price of US $3.50 a shot.”

Success with vaccines in disease prevention:

Diphtheria incidence in the US  – Mortality 5/10,000 cases Peak Incidence (1921) Incidence today

2,06,939

1

 

Tetanus incidence in the US – Mortality 3/10 cases Peak Incidence (1927) Incidence today

1,314

40

 

H. Influenza type B incidence in the US – Mortality 2-3/100 cases Peak Incidence (1927) Incidence today

20,000

363

Source: Ehreth Vaccine 21:4105-4117

Development of vaccines through the passage of time:

No. of vaccines

Year

Vaccines

1. 1780-1800

Smallpox

(first vaccine for any disease)

2. 1860-1880

Cholera

1880-1900

Rabies

6.

Tetanus

Typhoid fever

Bubonic plague

11 1920-1940

Diphtheria

Pertussis

Tuberculosis

Yellow fever

Typhus

16 1940-1960

Influenza

Polio

Japanese encephalitis

Anthrax

Adenovirus-4 and 7

24 1960-1980

Oral polio

Measles

Mumps

Rubella

Chicken pox

Pneumonia

Meningitis

Hepatitis B

28 1980-2000

Haemophilus influenzae type b

Hepatitis A

Lyme disease

Rotavirus

29 2000-2010

Human papilloma virus

Current trend in vaccine development:

Malarial Vaccine:

Reuters on December 20, 2011 reported that an experimental malaria vaccine has been developed by the British scientists, which has the potential to neutralize all strains of the most deadly species of malaria parasite.

In October 2011, the data published for a large clinical trial conducted in Africa by GlaxoSmithKline on their experimental malaria vaccine revealed that the risk of children getting malaria had halved with this vaccine. Reuters also reported that other teams of researchers around the world are now working on different approaches to develop a malaria vaccine.

Tuberculosis vaccines:

On August 11, 2011, Aeras and the Oxford-Emergent Tuberculosis Consortium (OETC) announced with a ‘Press Release’ the commencement of a Phase IIb ‘proof-of-concept efficacy trial’ of a new investigational tuberculosis (TB) vaccine. OETC indicated that clinical trial for the drug will be undertaken by them in Senegal and South Africa with primary funding support from the European and Developing Countries Clinical Trials Partnership (EDCTP).

Cancer vaccines:

Cancer vaccines are, in fact, biological response modifiers, which work by stimulating or restoring the ability of the immune system to fight the disease. There are two broad types of cancer vaccines:

  • Preventive vaccines:  To prevent cancer in healthy people
  • Therapeutic vaccines:  To treat cancer by strengthening the natural defense mechanism of the human body against the disease.

The United States Food and Drug Administration (US-FDA) has approved the following cancer vaccines, which protect against two types of HPV that cause approximately 70% of all cases of cervical cancer globally:

  • Gardasil of Merck & Company
  • Cervarix of  GlaxoSmithKline

The US FDA has also approved a cancer preventive vaccine that protects against HBV infection, which can cause liver cancer. It has been reported that the original HBV vaccine was approved in 1981 and currently most children in the US are vaccinated against HBV after their birth.

In addition, the US regulator has also approved a cancer vaccine for treatment of certain types of metastatic prostate cancer.

HIV Vaccines:

‘The AIDS Vaccine 2011 conference’ held in Bangkok in the month of September, 2011 discussed some of the latest findings on the following two vaccines for prevention and control of HIV disease progression:

  • A large trial of RV 144 vaccine in Thailand demonstrated the proof of concept that a preventive vaccine with a risk reduction of 31% could effectively work.  The trial was supported by the World Health Organization (WHO) and UNAIDS.
  • Bionor Pharma announced that clinical trial participants who received Vacc-4x “experienced a 70% viral load decrease relative to their level before starting Anti-Retroviral Therapy (ART), compared with no notable reduction among placebo recipients.”

Promising ‘Therapeutic Vaccines’ undergoing clinical trial:

‘FierceVaccines’ in its October 27, 2011 reported the following 10 most promising therapeutic vaccines, which are now undergoing clinical trials on humans:

Molecule Company Indication
ICT-107 ImmunoCellular Therapeutics Glioblastoma
VGX-3100 Inovio Pharmaceuticals Cervical cancer
MAGE-A3 GlaxoSmithKline Skin, lung cancer
Neu-Vax RXi Pharmaceuticals Breast cancer
AE37 Antigen Express Breast cancer
NexVax2 ImmusanT Celiac disease
ADXS-HPV Advaxis Cervical, head and neck cancer
CRS-207 Aduro BioTech Pancreatic cancer
PEV7 Pevion Biotech Recurrent vulvovaginal candidiasis
GI-4000 GlobeImmune Pancreatic cancer

Future scope for cancer vaccines:

One school of scientists firmly believes that out of all cancers diagnosed each year globally, various types of microbes contribute 15% to 25% as a causative factor for this dreaded disease, as indicated below:

Infectious Agents

Type of Organism

Associated Cancers

Hepatitis B virus (HBV)

Virus

Hepatocellular carcinoma(a type of liver cancer)
Hepatitis C virus (HCV)

Virus

Hepatocellular carcinoma(a type of liver cancer)
Human papilloma virus (HPV) types 16 and 18, as well as other HPV types

Virus

Cervical cancer; vaginal cancer;vulvar cancer; oropharyngeal cancer(cancers of the base of the tongue,

tonsils, or upper throat);

anal cancer; penile cancer;

squamous cell carcinoma of the skin

Epstein-Barr virus

Virus

Cancer of the upper part ofthe throat behind the nose
Human herpes virus 8 (HHV8)

Virus

Kaposi sarcoma
Human T-cell lymphotropic virus

Virus

Adult T-cell leukemia/lymphoma
Helicobacter pylori

Bacterium

Stomach cancer
Schistosomes

Parasite

Bladder cancer
Liver flukes

Parasite

Cholangio carcinoma(a type of liver cancer)

Source: The International Agency for Research on Cancer (IARC)

These findings open the doors of unique opportunities to develop both preventive and therapeutic vaccines to address the life threatening near fatal ailment of mankind – cancer.

Conclusion:

Developing countries of the world are now demanding more of those vaccines, which no longer feature in the immunization schedules of the developed nations. Thus to supply these vaccines at low cost will be a challenge, especially for the global vaccine manufacturers, unless the low margins get well compensated by high institutional demand.

To effectively focus on all important disease prevention initiatives, there is also a need to build a vibrant vaccine business sector in India. To achieve these dual objectives the government should create an enabling ecosystem for the vaccine manufacturers, academics and the government funded vaccine R&D centers to concentrate more with the relevant vaccine development projects ensuring a decent return on investments, for long term public health interest.

More often than not, the above stakeholders find it difficult to deploy sufficient fund to take their vaccine projects successfully through various stages of clinical development to obtain marketing approval from the drug regulator, working out a decent return on investments. This critical issue needs to be appropriately and urgently addressed by the Government to make the disease prevention initiatives in the country sustainable, demonstrating to all concerned that disease ‘prevention is better than cure’.

By: Tapan J 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.

Infections may cause NCDs like, diabetes and cancer: Ongoing scientific quest to decipher the mystery

To create a positive health impact on the lives of billions of people, the United Nations (UN) on September 19, 2011 unanimously adopted a ‘Political Declaration’ on ‘Non Communicable Diseases (NCDs)’.  In the years ahead, this path-breaking initiative on NCDs, with global commitment, is expected to make a huge difference in the lives of many, across the world.

NCDs have now been identified as a key healthcare challenge of this century and include ailments like, cardiovascular, chronic pulmonary diseases, diabetes, arthritis and cancer. In the developing countries, over 80% of all deaths are related to NCDs.

There are times when NCDs raise issues related to social justice and human rights. For example, in a country like India where out of pocket expenses towards healthcare is around 80%, a major illness like cancer even in a middle income group family, can drive the entire household to huge socioeconomic hardship.

NCDs are preventable:

According to the World Health Organization (WHO), adequate physical activity, healthy diet/nutrition and tobacco avoidance can prevent:

  • 80% of premature heart disease
  • 80% of type II diabetes
  • 40% of cancers

Currently, as we shall see below, immunization is also being considered as a preventive therapy for certain types of NCDs.

NCDs may be of infectious origin:

Dr. Bennett Lorber in his article titled, ‘Are All Diseases Infectious?’, published in the ‘Annals of Internal medicine’ wrote that many common NCDs like, cardiovascular, diabetes, peptic ulcer, arthritis and even certain types of cancer originate from infections by micro-organisms.

Mainly because of this reason and its consequent adverse socioeconomic impact, the low and middle income countries of the world will require controlling many types of infections, possibly through immunization, before they ultimately develop into NCDs.  Such measures, in turn, will help them reducing the risk factors of morbidity and mortality related to NCDs.

Infections and NCDs:

As indicated above by Dr. Bennett Lorber, following are some examples of reported relationship between infection and NCDs:

Reactive Arthritis:

Reactive arthritis or spondyloarthropathy has been known to follow intestinal infection with Salmonella typhimurium and Yersinia enterocolitica or urethral infection with Chlamydia trachomatis.

Scientists from the United Kingdom have already announced that they will soon begin human trial of an experimental rheumatoid arthritis vaccine.

Peptic Ulcer and Gastric Carcinoma:

Helicobacter pylori is known to cause of gastritis and peptic ulcer disease and is an important risk factor for gastric carcinoma.

Researchers at Rhode Island Hospital in collaboration with the University of Rhode Island and EpiVax Inc, have identified a potential vaccine to reduce colonization of Helicobacter pylori, which is known to cause peptic ulcer and gastric carcinoma.

Acute Renal Failure:

It was reported that about 10% of infected persons younger than 10 years of age develop hemolytic uremic syndrome, and as many as 75% of cases of the syndrome in the United States are complications of intestinal infection with E. coli.

Vasculitis:

The most common cause of vascular damage in secondary vasculitis is now considered to be related to different types of microorganisms. Patients were reported to have developed polyarteritis nodosa a few months after having hepatitis B infection.

It is widely reported that in the developed countries most common vasculitis is related to hepatitis B and C. However, in the developing world HIV related vasculitis appears to be  common.

Inflammatory Bowel Disease (IBS)/ Crohn’s Disease:

The precise etiology of Crohn’s Disease though remains to be conclusively deciphered, it is  believed by many researchers that the disease develops due to a reaction to a persistent intestinal infection in vascular endothelial cells.

Diabetes:

A good number of experts support a link between infection with enteroviruses in the pancreata and insulin-dependent diabetes mellitus.

To arrest or slow the autoimmune response that destroys insulin-producing cells in diabetes, it has been reported that the Diamyd vaccine, now in Phase III clinical trial in both USA and Europe, has shown very promising results.

Coronary Artery Disease:

A study published in the journal of ‘Clinical Infectious Disease’, Volume 40, Issue 8 ‘demonstrates a significant association between high titers to C. pneumoniae IgG and IgA and acute Myocardial Infarction (MI) in a cohort of young men and suggests that recent or chronic active infections could be associated with an increased risk for MI.’

In other studies also, patients with acute myocardial infarction were found to have elevated serum antibody levels to Chlamydia pneumoniae. This opens up possibility of preventing heart attacks with a vaccine.

Cancer:

The US FDA has already approved two types of vaccines for cancer prevention:

  • Vaccines against the hepatitis B virus, which can cause liver cancer.
  • Vaccines against human papillomavirus, which are responsible for about 70% of cervical cancers.

In addition, US FDA has also approved another cancer vaccine for metastatic prostate cancer.

A type of cancer known as Kaposi sarcoma is linked to an infectious agent found in patients with  acquired immune-deficiency syndrome. Scientists are in the process of developing treatment vaccines against many types of cancer.

Conclusions:

In the field of NCD, a not so widely publicized scientific revolution is in the making. Many well researched findings have, to a great extent, established that infectious agents could be the causative/precipitative or risk factors for NCDs like, chronic pulmonary and cardiovascular diseases, diabetes and cancer.

The moot question raised by Dr. Bennett Lorber earlier:  ‘Are all diseases infectious?’, is gradually getting answered through intensive scientific research. Otherwise, who would have thought, until recently, that vaccines could be developed for diabetes, certain types of cancer or even peptic ulcer?

Such path breaking scientific research findings are, in turn, creating a hope and opportunity for disease prevention through immunization for many NCDs, especially for the developing nations of the world.

It is very heartening to know that United Nations (UN) have taken note of these revolutionary developments in the ‘Non Communicable Disease’ space and are deliberating on the effective ways to combat NCDs caused by infections with the development and use of appropriate vaccines.

The entire world eagerly awaits more actionable outcome of the ongoing scientific quest to decipher the mystery related to many more NCDs to ensure better health of mankind of the Planet Earth.

By: Tapan J 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.