Tag Archives: Quality

A Force Multiplier: An “Armageddon”: A Contender for Supremacy in the Generic Pharma World

Posted on by
Reply

It is very important for any country to ensure access to most appropriate medicines for the patients as and when they require. In many disease areas such access can be remarkably improved through affordable generic drugs, which offer significant savings in cost for absence of monopolistic situation and intense competitive pressures.

In many countries like, India and China to further augment this process, the Government price control on essential medicines is already in force.

A paper titled, “Generic Medicines: Essential contributors to the long-term health of society” highlights the following facts on such drugs:

• Provide an affordable, gold standard medication for many major illnesses

• Allow access to medicines for a greater proportion of the population

• Stimulate healthy competition with the branded sector

• Deliver savings to national health bills

• Are high quality products

Generic companies also innovate:

The same paper also highlights, though innovation has been traditionally perceived as the domain of the research-based originator companies, generic medicine companies often spend significant sums on innovating and improving formulations, enhancing delivery systems and finding solutions to patient compliance issues.

It also says, the generics medicine industry spent 7 percent of revenues on R&D alone, in 2007 and created 150, 000 jobs only in the EU.

Continuous growth of generic drug industry is critical:

Taking all these factors into consideration, continuous growth of the generic drug industry is critical in ensuring broad access to medicines to the population of any country at an affordable price. Nothing else can achieve this objective.

In the developed countries like, Canada, Denmark, Germany, Netherlands, UK and even USA, large volume of generic medicines are prescribed. Most of these countries have put in place appropriate regulations that facilitate market entry of generic drugs soon after patent expiry. All of them, by and large, encourage even more prescriptions of generic medicines.

Of course, there are many instances of deliberate attempts to slow down generic entry, which I shall deal with separately at some other time.

Quality perception for generic drugs:

In many countries the general perception of efficacy and safety standards of generic drugs is still not satisfactory. In many occasions, these are reportedly prompted by well orchestrated campaigns by interested private stakeholders in this area.

However, in markets, like the EU, Canada and the USA Governments do take public awareness measures to dispel such doubt. Unfortunately not enough similar initiatives have been taken in India with tangible results. The reason could probably lie in the existence of a powerful branded generic lobby in the country, unlike many other markets of the world.

The market:

A report of Frost & Sullivan titled, “Generic Pharmaceuticals Market – A Global Analysis” stated, the global generic pharmaceuticals market registered a revenue of US$ 135.85 billion in 2010 with a growth rate of 11 percent. The top eight global markets, namely the United States, Germany, France, the United Kingdom, Canada, Italy, Spain and Japan account for 80 percent of the total generics market. The United States will continue to remain the largest market in the world for generic pharmaceuticals in value terms.

It is estimated, the global generic drug market will grow to US$ 231.02 billion by 2017 with a CAGR 9.3 percent from 2010. The key growth drivers being:

  • Patent expiration of some blockbuster drugs
  • Entry of more biosimilars
  • High growth of emerging markets
  • Cost containment measures of governments and healthcare service providers in various countries

BRIC Countries strongly defend generic drugs:

Allegation of attacks on the generic industry by the patent holders of various drugs is also heard quite frequently.

It was reported that in a TRIPS Council meeting in mid 2012 held at the World Trade Organization (WTO), India, Brazil and China defended the right of access to cheap generic medicines by poor countries, strongly resisting attempts by the US, Japan and some other developed countries to club counterfeits or copies of patented drugs with fake or spurious ones.

They also argued that infringing intellectual property rights should not be confused with sub-standard products.

Many believe that because of the reported ‘clout of India, China and Brazil’ in the WTO, this attempt may not fructify despite such attempts.

India is surging ahead:      

It is interesting to note that out of top 10 fastest growing generic companies of the world, 4 are of Indian origin namely Glenmark, DRL, Sun Pharma and Taro (owned by Sun Pharma) and 3 definitely are home grown Indian companies, as follows:        

Top 10 Fastest Growing Generic Companies of the World:

No. Company Country Sales US$ Million Growth 2011 (%) Growth 2010 (%)
1. Sagent Pharmaceuticals USA 152 106 153
2. Perrigo USA 620 80 45
3. Nichi-Iko Pharmaceutical Japan 1300 79 25
4. Watson Pharmaceuticals USA 3320 46 38
5. Glenmark India 778 37 17
6. Dr. Reddy’s Laboratories (DRL) India 1480 34 15
7. Taro Pharmaceutical Israel 436 33 11
8. Sun Pharmaceuticals India 1650 29 52
9. Veropharm Russia 156 24 28
10. Polpharma Poland 580 22 20

(Source: FiercePharma)

India the pharmacy of the developing world:

According to a recent report India is now emerging as the ‘Pharmacy of the Developing World’, as it produces a large volume of high-quality, affordable generic medicines.

The study also highlights, “as a result of tough competition from the generic players of India, the price of first-line ARVs dropped from more than US$ 10,000 per person per year in 2000 to around $150 per person per year today. This significant price decrease has helped to facilitate the massive expansion of HIV treatment worldwide: more than 80 percent of the HIV medicines used to treat 6.6 million people in developing countries come from Indian producers, and 90 percent of pediatric HIV medicines are Indian-produced.”

Another study indicates, as a result of phenomenal success of the homegrown pharmaceutical companies:

  • 67 percent of medicines exports from India go to developing countries.
  • Main procurement agencies for developing countries’ health programs purchase their 
medicines in India, where there are quality products at low prices.
  • Approx. 50 percent of the essential medicines that UNICEF distributes in developing countries 
come from India.
  • 75-80 percent of all medicines distributed by the International Dispensary Association (IDA) to 
developing countries are manufactured in India. (IDA is a medical supplier operating on a 
not-for-profit basis for distribution of essential medicines to developing countries.)
  • In Zimbabwe, 75 percent of tenders for medicines for all public sector health facilities come from 
Indian manufacturers,
  • The state procurement agency in Lesotho, NDSO, states it buys nearly 95 percent of all ARVs 
from India.

This situation is going to further improve at a galloping pace in the years ahead with proper encouragement from the Government of India.

India tops the chart for ANDAs:

India, with its rapidly growing homegrown generic players, continues to top the Chart for Abbreviated New Drugs Applications (ANDAs) with USFDA by increasing its share year after year, as follows:

Year

Global

India

India’s Share %

2007

492

133

24.1

2008

483

143

27.9

2009

419

132

31.3

2010

419

142

34.0

2011

431

144

33.4

2012

476

178

37.4

Source: Pharmabiz, January 7, 2013 / US FDA

India tops the Chart in DMFs also:

Similarly, India continues to top the Chart with its Drug Master Files (DMF) for Active Pharmaceutical Ingredients (APIs), as follows:

No. Countries Filing Type II DMF
 1. India 2759
 2. USA 1323
 3. China 870
 4. Italy 644
 5. Japan 270
 6. Spain 268
 7. Germany 266
 8. France 170
 9. Israel 170
 10. Switzerland 136

Source: Pharma Times, August 2012

Moreover, domestic pharmaceutical companies have now between themselves, around 175 USFDA and approximately 90 UK-MHRA approved manufacturing units, to cater to the needs of high quality and affordable pharma products across the world. 

India not loosing its R&D Focus:

Discovery of new drugs being the bedrock for the pharmaceutical industry, domestic Indian companies are also not loosing focus on R&D activities. The New Chemical Entity (NCE) pipeline of the homegrown companies as on 2012 is as follows:

Piramal Healthcare 23
Suven Life Sciences 14
Zydus Cadila 11
Glenmark 8
Biocon 7
Torrent Pharma 6
Sun Pharma 5
Wockhardt 5
Ranbaxy 2
Dr Reddy’s Lab 2
Others 5

Source: Citeline Intelligence Services: Pharma R&D Annual Review 2013

Is the “west pressurizing India to change tack?”

In an interesting article published in ‘The Guardian’, the author observed that the western Pharmaceutical companies are putting health of world’s poor at risk. It commented that India makes cheap medicines for poor people around the world, but the EU, pharmaceutical firms and now the US are pressuring the ‘pharmacy of the developing world’ to change track. The same sentiment was echoed in another article published in Pharma Times.

However, the experts do feel that the Government of India, mostly due to intense public pressure, is well prepared to address any such situation, come what may. Thus, despite any retarding forces coming into play, the incessant march of the home grown pharmaceutical companies in search of excellence, especially in this space, is expected to continue even at a brisker pace.

The triggering factor:

Experts opine that the reason for excellence of the domestic Indian pharmaceutical industry, especially in the generic pharma landscape, is due to the amendment of the Indian Patents Act in 1970 allowing only process patents for drugs and pharmaceuticals.

The Government of India reportedly had taken such a path-breaking decision in the 70’s to lay the foundation of a vibrant domestic pharmaceutical industry capable of manufacturing low cost and high quality modern medicines for the health security of the country leveraging latest technology, including IT.

This decision was also directed towards creation of ‘drug security’ for the country as in the 70’s India was very heavily dependent on drug imports and the domestic pharmaceutical industry was virtually non-existent. 

Conclusion:

Paying kudos to the pharmaceutical ‘Crown Jewels’ of India, many industry watchers feel that the global pharma players are now keener than ever before to work with the domestic pharma industry, in various areas of business. This augurs well for all, as it will help creating a win-win situation to add further momentum to the growth of the pharmaceutical industry of India.

Be that as it may, taken in entirety and strengthened by its well-balanced patent laws, India  will continue to have a significant force multiplier effect to emerge as a global force to reckon with, particularly in this important space.

In tandem, with other significant cutting edges, as mentioned above, India is now well poised to be an “armageddon” – a contender of supremacy as a “pharmacy of the developing economies” despite selective allegations and  detrimental efforts by some vested interests.

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.

 

 

Small Steps, yet Giant Leaps: In Pursuit of Affordable Medicines for All

Posted on by
Reply

Since last few years, some small yet very significant steps are being taken, mostly by the respective Governments, in and outside India, to provide affordable healthcare in general and affordable medicines in particular, for all.

It is well recognized that drug prices play as critical a role as a robust healthcare infrastructure and quality of its delivery system to provide affordable healthcare to the general population of any country. Thus, it is not a ‘chicken and egg’ situation. All these issues must be addressed simultaneously and with equally great care.

A WHO report:

A World Health Organization (WHO) titled, “Improving access to medicines through equitable financing and affordable prices” highlights as follows:

“In many countries medicines account for over half of total health expenditures and are often unavailable and unaffordable to consumers who need them. Up to 90% of the population in developing countries still buys medicines through out-of-pocket payments, and are often exposed to the risk of catastrophic expenditure.”

Definition of ‘Access to Medicines’:

How then one will define ‘access to medicines’?

United Nations Development Group, in a paper titled ‘Indicators for Monitoring the Millennium Development Goals (United Nations, New York, 2003) defined  ‘Access to Medicines’ as follows:

‘Having medicines continuously available and affordable at public or private health facilities or medicine outlets that are within one hour’s walk from the homes of the population.’

Healthcare ‘affordability’ is critical:

Despite healthcare infrastructure in India being inadequate with a slow pace of development, affordability of healthcare, including medicines, still remains critical. 

This is mainly because, even if a quality healthcare infrastructure together with an efficient delivery system is put in place without ensuring their affordability, patients’ access to quality healthcare products and services will not improve, especially in India, where private healthcare dominates.

Diversionary measures should not cause distraction:

Although, maximum possible resources must be garnered to address the critical issue of expanding quality healthcare infrastructure and delivery system sooner, the focus of the government, as stated above, must not get diverted from making healthcare products and services affordable to patients, at any cost.

This should continue despite diversionary measures from some quarter to deflect the focus of all concerned from affordability of healthcare to lack of adequate healthcare infrastructure and its delivery mechanisms in India.

This, in no way, is an ‘either/or’ situation. India needs to resolve both the issues in a holistic way, sooner.

Small Steps:

In an earnest endeavor to provide affordable medicines to all, the following small and simple, yet significant steps have been taken in and outside India:

  1. Strong encouragement for generic drugs prescriptions
  2. Regulatory directive for prescriptions in generic names
  3. In case that does not work – Government initiative on Patient Empowerment

In this article, I shall try to capture all these three small steps.

1. Strong encouragement for generic drugs prescriptions:

A. Generic drugs improve access and reduce healthcare cost:

A Special Report From the ‘US-FDA Consumer Magazine’ and the FDA Center for Drug Evaluation and Research, Fourth Edition / January 2006 states that generic drugs offer significant savings to the consumers.

Quoting a 2002 study by the Schneider Institute for Health Policy at Brandeis University in Waltham, Mass., it reiterated that if Medicare increased the rate of generic usage to that of similar high-performing private sector health plans, its 40 million beneficiaries could see potential savings of US$14 billion.

Another US-FDA report titled, ‘Greater Access to Generic Drugs’ also reinforced the argument that rising costs of prescription drugs remain a major challenge for consumers, especially older Americans. To address this issue effectively generics can play a critical role by providing less expensive medications.

B. ‘Obamacare’ followed this direction resulting decline in spend on high priced Patented Drugs:

Recently The New York Times quoting IMS Health reported that nationwide turnover of patented drugs in the U.S actually dropped in 2012. This decline though was just by 1 percent to US$ 325 billion, is indeed very significant and happened due to increasing prescription trend for low cost generics across America since past several years.

It is interesting to note this trend in America where the cost of medicines account for just about 15 percent (against over 70 percent in India) of the nation’s health care expenditures.

IMS Health reported that in 2012, 84 percent of all prescriptions were dispensed as generics and estimated use of generics may reach even as high as 86 to 87 percent in the U.S.

However, many experts believe that this trend is a result of many blockbusters like Lipitor going off patent during this period and no major breakthrough medicines coming with perceptible added value in these large therapy areas.

That said, lesser number of small molecule blockbuster drugs is set to lose patent protection over the next several years and the complexity in manufacturing and getting marketing approvals of large molecule biosimilar drugs in the U.S could arrest this trend.

Biosimilar drugs though are available in European Union, are expected to be available in the America not before at least two more years.

Despite a sharp increase in prescriptions for generic drugs, some of the patented medicines came with ‘jaw-dropping’ price tags: four drugs approved in 2012 carry a yearly cost of more than US$ 200,000 per patient, though the cost of development of some of these drugs do not exceed US$ 250 million, as reported by Forbes.

2. Regulatory directive for prescriptions in generic names:

A. Different situation in India:

Although increasing trend of generic prescriptions is bringing down the overall cost of healthcare in general and for medicines in particular elsewhere in the world, the situation is quite different in India.

In India over 99 percent of over US$ 13 billion domestic pharmaceutical market constitutes predominantly of branded generics and some generic medicines without brand names.

B. Allegation of branded generic prescriptions linked with marketing malpractices:

As Reuters reported, quoting public health experts and some Indian doctors, that due to an unholy nexus between some pharmaceutical companies and a large section of the medical profession, drugs are not only dangerously overprescribed, but mostly expensive branded generics are prescribed to patients, instead of cheaper equivalents. The reports said that this situation can be ‘devastating for patients — physically and financially — in a country where health care is mostly private, out of pocket, unsubsidized and 400 million people live on less than US$ 1.25 a day’.

It is now a matter of raging debate that many branded generic prescriptions are closely linked with marketing malpractices.

Not just the media and for that matter even a Parliamentary Standing Committee in one of its reports highlighted, bribing doctors by many pharma players in various forms and garbs to prescribe their respective brand of generic drugs has now reached an alarming proportion in India, jeopardizing patients’ interest seriously, more than ever before and  observed that speedy remedial measures are of utmost importance.

C. MCI initiative on prescription in generic names: 

To address this major issue the Medical Council of India (MCI) in its circular dated January 21, 2013 addressed to the Dean/Principals of all the Medical Colleges, 
Director of all the hospitals and the
 Presidents of all the State Medical Councils directed as follows:

“The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 inter-alia prescribes as under regarding use of generic names of drugs vide clause 1.5.

1.5 – Use of Generic names of drugs: Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs.”

All the Registered Medical Practitioners under the IMC Act are directed to comply with the aforesaid provisions of the Regulations without fail.

You are requested to give wide publicity of the above regulation to ensure that all the doctors practicing medicine under your jurisdiction comply with the regulation.”

MCI also urged the Medical profession to implement the above provision for prescriptions in generic names both in its letter and spirit.

As the situation has not changed much just yet, it is up to the MCI now to enforce this regulation exactly the way as it has intended to. Otherwise the value of this circular will not even be worth the paper on which it was printed by this august regulatory body.

D. Parliamentary Standing Committee recommends it:

As mentioned above, prior to this circular, Parliamentary Standing Committee (PSC) for Health and Family Welfare in its recommendation to the ‘Rajya Sabha’ of the Indian Parliament on August 4, 2010, also recommended prescription of medicines by their generic names.

E. Why is the bogey of ‘product quality’ so active only for generic prescriptions and not for branded generics?

It is indeed difficult to fathom why is the product quality issue, which could make drugs unsafe for the patients, being raised so much for generic medicines without a brand name and not for branded generics?

The following questions should well be raised for greater clarity on the quality issue with generic medicines without a brand name, for all concerned:

  • Are all generic medicines of dubious quality and branded generics are of good quality?
  • If quality parameters can be doubted for both branded generics and generics without a brand name, in many cases, why then raise this issue only in context of prescribing generic medicines ?
  • If quality issues are not much with the larger companies and are restricted to only smaller companies, why then some branded generic drugs of smaller companies are being prescribed so much by the doctors?
  • Currently many large companies market the same drugs both as generics without a brand name and also as branded generics, why then the branded generic versions are prescribed more than their generic equivalents, though manufactured by the same large companies having the same quality profile?
  • Why are the generic medicines of good quality available at ‘Jan Aushadhi’ outlets (though small in number) cost a fraction of their branded generic equivalents and not being prescribed by most of the doctors?
  • Why do the doctors not show much interest in prescribing generic medicines as of date and defend the branded generics on the same ‘quality’ platform?
  • Why not those who argue that phonetically similar or wrong reading of generic names at the chemist outlets may cause health safety hazard to the patients, also realize that many already existing phonetically similar brand names in totally different therapy areas may cause similar hazards too?
  • How does a doctor while prescribing a branded generic or generic medicine pre-judge which ones are of good quality and which others are not?

These questions, though may be uncomfortable to many, nevertheless merit clear, unambiguous, straight and specific answers.

3. In case MCI directive does not work – Government initiative on ‘Patient Empowerment’:

A. Laudable Government initiative:

Recognizing this issue in tandem, on December 7, 2012 the Department of Pharmaceuticals together with the National Pharmaceutical Pricing Authority announced as follows:

“There are number of drugs available in the market with same medicament composition with wide variation in their prices.  The prescription of doctors also varies from low price to high priced drugs for the same ailment. Government of India intends to launch an SMS based patient awareness scheme, which would enable the patients to know the cheaper alternatives medicines available”.

The timeline for implementation of this initiative was announced as six month from the date of awarding the contract.

It was reported that in this mobile phone based program, consumers by sending a text message of any branded generic drug prescribed by the doctors would get an SMS reply with a list of brands of the same molecule along with their prices to exercise their choice of purchase.

As usually happens with most government decisions, the gestation period of this laudable ‘patient empowerment’ initiative perhaps will get over not before end 2013.

B. One interesting private initiative:

One interesting private websites that I have recently come across offering information on branded generic drugs is www.mydawaai.com (I have quoted this website just to cite an example and not to recommend or promote it in any form or manner). There may be other such websites, as well, in the cyberspace.

However, in this website, if anyone types the brand name of the drug that one is looking for, the following details will be available:

  1. The generic version of branded medicine.
  2. The company manufacturing the brand.
  3. Its estimated cost in India
  4. Alternative brand names with same generic salt.
  5. The cost effectiveness for different brand for the same salt.

Such information, if available easily from the Government or any highly credible source, will indeed help patients having access to affordable low cost medicines to lessen their out of pocket financial burden, at least for medicines.

Conclusion:

In India, even if branded generic prescriptions continue despite MCI directive, to empower patients making an informed choice to buy low priced formulations of the same prescribed molecule, the above ‘Patient Empowerment’ initiative will play a very critical role.

Thus, I reckon, to improve access to affordable medicines in India, like many other countries elsewhere in the world, the above small steps that are being taken by the MCI, the Department of Pharmaceuticals, the National Pharmaceutical Pricing Authority and other private players are indeed laudable and must be encouraged.

Kudos will pour in, from India and abroad, if such small and simple steps get ultimately translated into a giant leap in the healthcare space of the country…for patients’ sake.

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.

e-Patients: Quality and Cost Empowered Patients Will Help Reducing Healthcare Costs in India Significantly

Posted on by
Reply

Currently many important stakeholders of the healthcare industry, reportedly, are using or rather exploiting the individual patients not just to derive petty commercials gains, but also for quite significant strategic commercial advantages, mainly due to ignorance or helplessness of a large section of the ailing population of India.

The Lancet:

A relatively recent report on India dated January 11, 2011, published in ‘The Lancet’, states in a similar, though not exactly the same context, as follows: 1. “Reported problems (which patients face while getting treated at a private doctor’s clinic) include unnecessary tests and procedures, rewards for referrals, lack of quality standards and irrational use of injection and drugs. Since no national regulations exist for provider standards and treatment protocols for healthcare, over diagnosis, over treatment and maltreatment are common.” 2. “Most people accessed private providers for outpatient care – 78% in rural areas and 81% in urban areas.” 3. “India’s private expenditure of nearly 80% of total expenditure on health was much higher than that in China, Sri Lanka and Thailand.” Considering the above critical issues of India, as reported by ‘The Lancet’, it is rather apparent that these stakeholders could be doctors, hospitals, diagnostic centers, pharmaceutical industry, even activists and politicians. It is unfortunate that they all, sometime or the other use the patients as pawns to achieve their respective commercial or political goals or to achieve competitive gains of various types prompted by vested interests.

e-Patients:

e-Patients or empowered patients can play a very important role in India to take this raging bull by its horn to liberate themselves from such kind of a pathetic environmental condition.

The term e-Patients may be defined as those who seek or are encouraged to seek information regarding various therapeutic options, which will enable them to actively participate in the decision making process on whether or how to undergo a diagnostic or therapeutic procedure at the right cost or the pros and cons of pursuing other available alternatives.

In this sense, a large majority of patients in India are not empowered at all with health and disease related information. Despite unprecedented access to health related information in the cyberspace and elsewhere, not only a large section of the industry, but also majority within the medical profession, in general, does not seem to quite believe in the concept of e-Patients, as yet.

Though all concerned speak and even pontify about ‘Patient Centric’ approaches, at the ground level, most of them do not seem to walk the talk for tangible benefits of the patients.

In this context the news appeared earlier this month reporting  that patients would soon be able to find the most affordable alternative to the medicine prescribed by the doctors through an SMS-based service, is a breath of fresh air.

The report stated, “The government plans to cover at least two-thirds of the prescription market through this scheme, which would include all widely used therapies like anti-infectives, painkillers, respiratory and gastro-intestinal drugs.”

This initiative, if becomes successful, can certainly be termed as one of the praiseworthy e-Patient related schemes of the Government.

Role of the Civil Society along with the Government:

Under the prevailing scenario, the government and the civil society, in tandem, should encourage creation of more and more e-Patients by making them understand how the healthcare system is currently working on the ground, what and which are the key obstacles in getting reasonably decent healthcare support in India and what should be done to uproot these barriers in civilized ways.

A movement yet to gather its full steam:

e-Patient movement first started in America in the 70’s, which asserts that for truly healthy living, one should get engaged in transforming the social situation and environment affecting their lives, demanding a greater say in their treatment process and observing the following tenets:

Patients’ choice and lifestyle cannot be dictated by others.

  • ‘Patient empowerment’ is necessary even for preventive medicines to be effective.
  • Patients, just like any other consumers, have the right to make their own choices.

The ‘Empowered Patient’ should always play the role of a participating partner in the healthcare process.

e-Patients will help reducing the growing trust-deficit:

In today’s world, the distrust of patients on the healthcare system, pharmaceutical companies and the drug regulators, is growing all over the world, including in India. This situation makes an e- Patient resolve to actively participate in the decision making process of his/her required medical treatment.

Under the above circumstances, other stakeholders will have no other option but to take a ‘Patient-Centric’ posture in its real sense, the seeds of which are slowly and gradually being sown in India, as cited above.

In India, as ‘out-of-pocket’ healthcare expenses are skyrocketing, in the absence of a comprehensive and affordable universal health  coverage, e- Patients’ will increasingly demand to know more of not only the available treatment choices, but also about the medicine prescriptions options.

e-patients will prompt a change in basic sales and marketing models of the pharmaceutical companies:

Not so long ago, to generate increasing prescription demand and influence the prescription decision of the doctors, the pharmaceutical companies used to provide product information to the medical profession through various persuasive means of the sales forces along with samples and a variety gifts, besides meeting their unmet needs with innovative medicines.

The above approach though still working well in India, will no longer fetch desired results to the pharmaceutical companies, as we move on, just as what is happening in the developed markets of the world.

e- Patients have already started demanding much more from the pharma players even through their doctors. As a result, many global companies are now cutting down on their sales force size to try to move away from just hard selling by gaining more time from the doctors.  They have started taking new initiatives to open up a chain of direct communication with their primary and secondary customers with an objective to know more about them to satisfy them better.

In future, growing number of e-Patients is expected to prompt a radical change in the basic sales and marketing models of the pharmaceutical companies. At that time, so called ‘Patient-Centric’ companies of today will have no choice but to walk the talk.

Consequently, they will have to willy-nilly switch from the ‘hard-selling mode’ to a new process of achieving business excellence through constant endeavor to satisfy both the expressed and the un-expressed needs of the patients, not just with innovative products, but more with innovative and caring services.

Growing influence of e-patients in their healthcare decision making process:

In the years ahead, growing number of e- Patients is expected to play an important role in their healthcare decision making process, initially in urban India, ensuring further improvement not just in the public and private healthcare systems, but also in inviting the pharmaceutical industry to be a part of that changing process.

In the book titled, “The Empowered Patient: How to Get the Right Diagnosis, Buy the Cheapest Drugs, Beat Your Insurance Company, and Get the Best Medical Care Every Time”, Elizabeth Cohen articulated as follows:

“The facts are alarming. Medical errors kill more people each year than AIDS, breast cancer or car accidents. A doctor’s relationship with pharmaceutical companies may influence his choice of drugs for you. The wrong key word on an insurance claim can deny you coverage.”

‘USA Today’ dated August 31, 2010 in an article titled, “More empowered patients question doctors’ orders,” reported:

‘In the past, most patients placed their entire trust in the hands of their physician. Your doc said you needed a certain medical test, you got it. Not so much anymore.’ 

Unfortunately in India, the pace of this change is rather slow as on date. All stakeholders of the healthcare industry need to think now more of inclusive growth, not just the commercial growth of the respective organizations, which could further widen the socioeconomic divide in India, creating numbers of serious social issues. As we know, this divide has already started widening at a brisk pace, especially in the healthcare sector of the country, the impact of which we have started reading in the media much too often now.

Influence of e-patients in the R&D process:

Reinhard Angelmar, the Salmon and Rameau Fellow in Healthcare Management and Professor of Marketing at INSEAD, was quoted saying that ‘Empowered Patients’ can make an impact even before the drug is available to them.

He cited instances of how the empowered breast cancer patients in the US played a crucial role not only in diverting funds from the Department of Defense to breast cancer research, but also in expediting the market authorization and improving market access of various other drugs.

Angelmar stated that e- Patients of the UK were instrumental in getting NICE, their watchdog for cost-effectiveness of medicines, to change its position on the Age-related Macular Degeneration (AMD) drug Lucentis of Novartis and approve it for wider use than originally contemplated by them.

e-Patients have started influencing the global pharma companies:

To respond to the challenges of change posed by the e-Patients, pharmaceutical companies, especially in the US and Europe are in the process of developing a more direct relationship with the patients (consumers). Creation of ‘Patient Empowered’ social networks may help to address this issue effectively.

For example, Becton, Dickinson and Co. created a web-based patient-engagement initiative called “Diabetes Learning Center” for the patients, not just to describe the causes of diabetes, but also to explain its symptoms and complications. From the website a patient can also learn how to inject insulin, along with detailed information about blood-glucose monitoring. They can even participate in interactive quizzes, download educational literature and learn through animated demonstrations about diabetes-care skills.

To cite one more example, companies like, Novo Nordisk is developing a vibrant patient community named ‘Juvenation’, which is a peer-to-peer social group of individuals suffering from Type 1 diabetes. This program was launched by the company in November 2008 and now the community has over 16,000 members, as available in its ‘Facebook’ page.

Some other Pharmaceutical Companies, who are in the process of engaging with the customers through social media like Twitter, are Pfizer, Johnson & Johnson, Novartis, Boehringer Ingelheim, AstraZeneca, Bayer, GlaxoSmithKline, Sanofi, Roche and Merck.

Conclusion:

Since the last few years, especially in the developed countries of the world, pharmaceutical companies have been talking about being ‘Patient Interest-Centric’ to ride squarely the increasingly powerful tide of ‘Patient Empowerment’ in their endeavor to satisfy the assertive demands of the new generation of healthcare consumers – the e-Patients.

However, in many cases the prevailing healthcare provisions, its structure and culture, together with stiff resistance of the regulators to let the industry engage directly with the patients, have inhibited the ‘Patient Interest-Centric’ intent of the stakeholders to take off the ground in a meaningful way.

At the same time, the aggressive marketing focus of the pharmaceutical industry and blatant commercialization of the system by the healthcare professionals, have more often than not failed to translate the good intent of ‘Patient Interest-Centric’ healthcare process into reality.

Increasing general awareness and rapid access to information on diseases, products and the cost-effective treatment processes through internet, in addition to fast communication within the patients/groups through social media like, ‘Twitter’ and ‘Facebook’ by more and more patients, I reckon, are expected to show the results of creation of more number of e-Patients in India.

As reported by the World Health Organization (WHO), at the First European Conference on ‘Patient Empowerment’ held in Copenhagen, Denmark on 11–12 April 2012, Robert Johnstone of the International Alliance of Patient Organizations said:

“What needs to happen is for doctors to come down off their pedestal and for patients to get up off their knees.”

To reduce healthcare costs significantly in India, let the government together with the civil society accelerate the process of creating more and more e-Patients – Quality and Cost-Empowered Patients in the country, avoiding any further delay. In that endeavor likes of SMS based services, as stated above, are expected to be just the small steps before a giant leap is taken towards this direction.

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.

e-healthcare: A new vista to improve access to quality and affordable healthcare in India

Posted on by
Reply

The concept of e-healthcare started germinating in India since 1999, when the ‘Indian Space Research Organization (ISRO)’ initiated its pioneering step towards telemedicine in the country by deploying a SATCOM-based telemedicine network. This network is currently playing a key role in the evolution and development of e-healthcare in the country. ISRO, with its fine blending of application of world class satellite communication technology with modern medical science and information technology (IT), has engaged itself very seriously to ensure availability of quality and affordable specialty healthcare services right at the doorsteps of a vast majority of population living even in the distant and remote places of the rural India.

However, despite telemedicine gaining slow momentum in India, there is no law in place for ethical, affordable and patient friendly use of e-healthcare facilities in the country.  Considering its vast scope of improving access to healthcare, cost effectiveness and a convenient ways to deliver e-healthcare services to a very large number of patients, especially, located in the distant locations of the country, the law makers should urgently ensure that this important healthcare service is not misused or abused by unscrupulous elements, in any way.

Very recently, taking into consideration this critical legal requirement the Medical Council of India (MCI) has decided to soon forming a panel to address the ethical issues related to e-healthcare in India.

Delivery of e-healthcare through telemedicine:

The World Health Organization (WHO) has defined telemedicine as follows: “The delivery of healthcare services, where distance is a critical factor, by all healthcare professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for continuing education of healthcare providers, all in the interests of advancing the health of individuals and their communities.”

As stated above, telemedicine is gradually gaining popularity in India, like in many other countries of the world. This emerging e- healthcare service has the potential to meet the unmet needs of the patients located in the far flung areas, by providing access to medical specialists for treatment of even tertiary level of their ailments, without requiring traveling outside their villages or small towns where they reside.

The key objectives of e-healthcare:

1. To provide affordable quality healthcare services even to those places where these are not available due to lack of basic healthcare infrastructure and delivery issues.

2. Speedy electronic transmission of clinical information of both synchronous and asynchronous types, involving voice and data transfer of patients to distantly located experts and get their treatment advice online.

3. To effectively train the medics and the paramedics located in distant places and proper management of healthcare delivery/service systems.

4. Disaster management.

The Process:

The process can be: – ‘Real time’ or synchronous when through a telecommunication link real time interaction between the patients and doctors/experts can take place. This technology can be used even for tele-robotic surgery. – ‘Non-real time’ or asynchronous type when through a telecommunication link, stored diagnostics/medical data and other details of the patients are transmitted to the specialists for off-line assessment and advice at a time of convenience of the specialists.

These processes facilitate access to specialists’ healthcare services by the rural patients and the medical practitioners alike by reducing avoidable travel time and related expenses. At the same time, such interaction would help upgrading the knowledge of rural medical practitioners and paramedics to hone their skill sets.

The Promise:

e-healthcare is capable of taking modern healthcare to remote rural areas using Information Technology (IT), as specialists are mostly located in the cities. As majority of the diseases do not require surgery, e-healthcare would prove to be very conducive to such patients and economical too.

Relevance of e-healthcare in India:

With its over 1.2 billion population and equally huge disease burden, spreading across distant semi-urban and rural areas, where over 70 per cent of the population of the country lives, India should focus on e-healthcare to meet unmet healthcare needs of the common man, at least, located in far-flung areas. e-healthcare, therefore, is very relevant for the country, as it faces a scarcity of both hospitals and medical specialists. In India for every 10,000 of the population just 0.6 doctors are available.

According to the Planning Commission, India is short of 600,000 doctors, 1 million nurses and 200,000 dental surgeons. It is interesting to note that 80 percent of doctors, 75 percent of dispensaries and 60 percent of hospitals, are situated in urban India.

Progress of e-healthcare in India:

Equitable access to healthcare is the overriding goal of the National Health Policy 2002. e-healthcare has a great potential to ensure that the inequities in the access to healthcare services are adequately addressed by the country.

Very encouragingly, a good number of even super-specialty hospitals like, Apollo Group of Hospitals have unfolded the launch plan of ‘Healthcare India Pharmaceutical Registry (HIPAAR)’, which is an electronic drug database for reference by the doctors and patients.  Apollo Group feels that HIPAAR module will enable the patients to know whether right medications have been used or not to treat the ailment that the concerned patient is suffering from along with the information of possible adverse effects of the medicines prescribed to them.

Currently, in the dedicated e-healthcare centers of ‘Narayana Hrudayalaya group’ pioneered by Dr Devi Shetty, patients from far-flung areas can have consultations with doctors in Bangalore.

Similarly, Asia Heart Foundation (Kolkata) and Regional Institute of Medical Science (Imphal, Manipur) are currently providing multi-specialty e-healthcare through telemedicine to 10 district hospitals, which will be extended to 75 District Hospitals, shortly. At the same time, some Government hospitals also have started extending e-healthcare through telemedicine facilities, which among others will handle e-transfer of medical data of patients like, X-ray, CT scan and MRI for not only diagnosing the disease, but also for treatment and medical consultation. Department of telemedicine of Sir Ganga Ram Hospital of New Delhi is one such example.

Well reputed cancer hospital of India, Tata Memorial Hospital (TMH) of Mumbai is now well connected with B.Barooah Cancer Institute of Guwahati, Assam and K.L Walawalkar Cancer Center of Chiplun, Maharashtra. Over a short period of time TMH plans to connect with 19 such regional cancer institutes.

Today the Center for Health Market Innovations (CHMI), a global network of partners that seeks to improve the functioning of health markets in developing countries to deliver better results for the poor, profiles more than 55 telemedicine programs globally including 24 in India.

Public Private Partnership:

As the Ministry of Health and Family welfare has now constituted a ‘National Telemedicine Taskforce’, some private healthcare institutions, as mentioned above, and various State Governments like, Tamil Nadu, Andhra Pradesh, Kerala and West Bengal have started taking admirable initiatives to translate the concept of e-healthcare into reality, especially for the rural India. Subsequently, private e-healthcare solution providers have also started coming-up, though in a sporadic manner.  Active participation of the civil society and meaningful Public Private Partnership (PPP) projects are essential not only to get engaged in creating awareness for e-healthcare within India, but also to ensure that required blend of a high quality technical and medical manpower that the country currently possesses are effectively utilized to establish India as a pioneering nation and a model to emulate, in the field of e-healthcare.

The market of e-healthcare in India:

Frost & Sullivan (2007) estimated the e-healthcare (telemedicine) market of India at US$3.4 million is expected to record a CAGR of over 21 percent between 2007 and 2014.

More fund required for e-healthcare:

e-healthcare shows an immense potential within the fragile brick and mortar public healthcare infrastructure of India to catapult rural healthcare services, especially secondary and tertiary healthcare, to a different level altogether. Current data indicate that over 278 hospitals in India have already been provided with telemedicine facilities. 235 small hospitals including those in rural areas are now connected to 43 specialty hospitals. ISRO provides the hospitals with telemedicine systems including software, hardware, communication equipment and even satellite bandwidth. The state governments and private hospitals are now required to allocate adequate funds to further develop and improve penetration of Telemedicine facilities in India.

Issues with e-healthcare in India:

– Telemedicine will not be immune to various complicated legal, social, technical and consumer related issues.

- Some government doctors could feel that for e-healthcare they need to work extra hours without commensurate monetary compensation

- The myth created that setting up and running any e-healthcare facility is expensive, needs to be broken, as all the related costs can be easily recovered by a hospital through nominal charges to a large number of patients, who will be willing to avail e-healthcare facilities, especially from distant parts of India.

- Inadequate and uninterrupted availability of power supply could limit proper functioning of the e-healthcare centers.

- High quality of telemedicine related voice and data transfer is of utmost importance. Any compromise in this area could have a significant impact on the treatment outcome of a patient.

- Lack of trained manpower for e-healthcare services needs to be addressed quickly by making it a part of regular medical college curriculum, just as the University of Queensland in Australia has it for their Graduate Certificate in e-Healthcare (GCeH). A pool of competent professionals for e-healthcare services in the country will be a step in the right direction.

- Reimbursement procedure of e-healthcare treatment costs by the medical insurance companies needs to be effectively addressed.

Conclusion:

For an integrated and sustainable healthcare delivery model covering the entire population of the country, a robust e-healthcare strategy is absolutely essential.  Three critical success factors for e-Healthcare initiatives may be considered as follows:

  1. A comprehensive government policy
  2. Increasing level of literacy
  3. Power and telecommunications infrastructure

Unlike common perception, for greater effectiveness and better acceptance of any sustainable e-healthcare service project, the focus should be the same or rather a little more on non-technological areas like consumer mindset and competent healthcare providers than technological factors such as biomedical engineering or information technology.

A very large rural population of India living in remote areas could get access to affordable and quality health related services through e-healthcare facilities, which, I reckon, should be made to play a very special and critical role to address the healthcare needs of the common man. With its gradually increasing coverage, it is imperative that required regulatory standards and guidelines for e-healthcare are put in place across the country, sooner. Technological expertise to make e-healthcare successful is already available in India. The pioneering role that ISRO has been playing in this field is still not known to many.

Thus, to make e-healthcare successful, the country needs to create an appropriate groundswell for the same. All powerful and effective ‘Fourth Estate’ of the country should demonstrate greater interest to initiate a healthy discussion on e-healthcare by all stakeholders and play the role of a facilitator to ensure access to quality and affordable healthcare to all the people of India.

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.

Making quality medicines available at an affordable price – Are we ‘missing woods for the trees’?

Posted on by
Reply

On August 4, 2010 the Parliamentary standing committee for Health and Family Welfare in its 45th report, recommended the following to the ‘Rajya Sabha’ of the Parliament of India for ‘Making quality medicines available at an affordable price’ to the common man:

1. Blanket caps on the profit margins of all medicines across the board, as these are the ‘only items’ where the purchasing decision is taken by a doctor – a third party and not by the patients who will actually pay for such medicines. In such a situation, a possible’ unholy nexus’ between the prescribing doctors and the pharmaceutical companies could put the patients at a disadvantage and in a helpless situation.

2. This blanket cap on profit for ALL drugs will discourage pharmaceutical companies to shift the balance of their product portfolio from schedule (price control) to non-schedule (outside price control) formulations.

3. This action will make the administration of the ‘Price Control’ mechanism by the Government much simpler by eliminating the current practice of price monitoring and the government preference of substitution of generic drugs for the branded pharmaceuticals

4. MRP of ALL medicines should be determined by the NPPA based on an open and transparent process and considering interests of all stake holders, as is currently being followed in other areas like, electricity tariff, bus, auto rickshaw and taxi fares, insurance premiums and various interest rates.

5. The Department of Health and Family Welfare and the Department of Pharmaceuticals should work out a system through the Inter-Ministerial Coordination Committee to put a blanket cap on profit margins of ALL drugs across the board, immediately.

6. Despite amendment of the MCI guidelines for the doctors in December 2009, banning the acceptance of all kinds of gifts, trips to foreign destinations and availing various types of hospitality by them from the pharmaceutical companies, nothing much has changed on the ground related to such ’unethical practices’. Since MCI has no jurisdiction over the pharmaceutical companies, the government should formulate similar punitive steps through the DCGI, CBDT etc. against the erring pharmaceutical companies.

7. The Committee indicated that it desires to be kept apprised of the action taken in this regard by the Government.

The key factors influencing affordability of medicines:

All the above steps will remain as good intent by the policy makers, if the issue of access to medicines is not addressed simultaneously. As we know that affordability will have no meaning, if one does not have even access to medicines.

In my view, there are five key factors, which could ensure smooth access to medicines to the common man across the country; affordable price being just one of these factors:

1. A robust healthcare infrastructure
2. Affordable healthcare costs including pharmaceuticals
3. Rational selection and usage of drugs by all concerned
4. Availability of healthcare financing system like, health insurance
5. Efficient logistics and supply chain support throughout the country

High out of pocket expenditure could push a section of population below the poverty line:

In India ‘out of pocket expenditure’ as a percentage of total healthcare expenses is around 80%, being one of the highest in the world.

A study by the World Bank conducted in May 2001 titled, “India – Raising the Sights: Better Health Systems for India’s Poor” indicates that out-of-pocket medical costs alone may push 2.2% of the population below the poverty line in one year.

‘Missing woods for the trees’?

Affordability is indeed a relative yardstick. What is affordable to an average middle class population may not be affordable to the rest of the population even above the poverty line. Similarly, below the poverty line population may not be able to afford perhaps any cost towards medicines. In a situation like this, putting a blanket profit cap on all medicines will not be just enough. There is a crying need to put in place an appropriate healthcare financing model by the policy makers, covering all sections of the society. Are we then ‘missing woods for the trees’?

Create a robust healthcare provider group through Public Private Partnership (PPP) initiatives to offer quality healthcare at an affordable price:

To resolve the issue of affordability of healthcare in general including medicines, the policy makers should take immediate steps to put in place the ‘Healthcare Financing’ initiatives through a robust PPP model in the country. A highly competitive ‘Health Insurance’ sector, created through PPP, could emerge as a powerful and key healthcare provider in the country. The power that such stakeholders will then assume in deciding for their respective clientele, types of doctors, hospitals, diagnostic labs and even what types of medicines that will be dispensed to them to offer quality healthcare at an affordable price, could indeed be a game changer having an immense influence in bringing the cost of overall healthcare for the common man, including medicines, very significantly.

The ‘Health Insurance’ companies can then decide through the Third Party Administrators (TPA), based on public interest, what types of fees should be charged by the following to offer quality healthcare services at an affordable price to their clientele, if these groups would like to avail the huge business potential for a long period of time:

1. Doctors
2. Hospitals
3. Diagnostic laboratories
4. Other related service providers

For making centralized purchase of medicines, these insurance companies or payors may enter into a hard negotiation with the pharmaceutical companies directly to bring down the price of medicines for the use of their respective clientele.

A recent incident:

To illustrate the above point let me quote an important and related news item, which was published in almost all the leading national daily newspaper, just in the last month.

In July 2010, it was reported that about 18 health insurance companies, who were providing cashless services to the policy holders at over 3,000 hospitals across India, found out that only 350 of them constituting around 11% of the total, were consuming more than 80% of the total claims.

It was also reported that the patients were overcharged by these hospitals for each hospitalization irrespective of the treatment provided and were left with them very little funds for their next treatment. This prompted the said insurance companies to bring some order out of the chaos, as it were.

As a result, at least 150 hospitals only from Delhi and the National Capital region were taken out of their designated list for the cashless facility, keeping the facility available at around 100 hospitals where none belonged to any corporate chain. Similar action was taken against hospitals in other cities, as well.

Thereafter, these insurance companies also decided to convey to the invidual policy holders the fresh list of hospitals for cashless facilities, working out new treatment packages depending on the quality of available healthcare infrastructure of each hospital and a lower or a higher rate was worked out for implementation, accordingly.

This illustration will vindicate how powerful and assertive the health insurance companies could be with the effective use of the TPAs for the sake of public health interest, if they wish to and at the same time to protect their respective bottom lines, creating a win-win situation for all.

Conclusion:

It is indeed an irony that despite being the 4th largest producer of pharmaceuticals and catering to the needs of 20 per cent of the global requirements for the generic medicines, India is still unable to ensure access to modern medicines to around 650 million population of the country (The World Medicine Report, WHO 2004). Like in many other emerging economies of the world, in India too, access to modern medicines along with their affordability, is the key macro healthcare issue of the nation.

In a situation like this, as stated above, when the payors or health insurance companies will start exerting immense performance pressure to all concerned to provide quality healthcare at an affordable price, even the alleged ‘unholy nexus’ between the pharmaceutical companies and the medical profession, perhaps will not have any practical relevance.

It is worth pondering, whether the Government is now sending confusing signals to the civil society at large by propagating ‘non-regulated pricing’ for Petroleum Products and ‘regulated pricing’ for pharmaceutical products?

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.