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.
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:
- Strong encouragement for generic drugs prescriptions
- Regulatory directive for prescriptions in generic names
- 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:
- The generic version of branded medicine.
- The company manufacturing the brand.
- Its estimated cost in India
- Alternative brand names with same generic salt.
- 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.
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.