Taking issue on certain medical points

It was with great expectation that I opened pages 8 & 9 of The Sunday Times of April 20. I expected a well researched article by two investigative journalists. I was very disappointed to read an article which examined cursorily a subject that has been debated fairly extensively in the Daily Mirror and the Island newspapers. For example an article entitled “Some frequently asked questions on Generic Medicines and their Prices” in the two newspapers gave definitions, explanations and prescribing of generics and brands. It appears that the journalists have not read what has been written in the newspapers about generics and brands.

The Sunday Times report poses several questions which have been answered already in the above mentioned article. This apparently came about because The Sunday Times article, I believe is largely based on subjective individual doctor’s opinions, the antitheses of making decisions in medicine; what individual practitioners say, anecdotes, do not substitute for a careful reasoned analysis of what actually happens on the ground.

The article makes a shocking disclosure that there are some 20,000 pharmacies in the country but only 3000 qualified pharmacists. Added to this is another story of a youth who had scraped three passes at the advanced level examination who was accompanying his wife, a nurse, who was transferred to a hospital in Uva province to setup a pharmacy in the area. The first one is factually incorrect; the second is an impossibility. According to the drug regulatory authority (DRA) there are only 3000-3100 pharmacies, including retail and wholesale, in the country registered with the Ministry of Health. Therefore, the shocking disclosure of 20,000 pharmacies is incorrect. Secondly no one can open a pharmacy in the Uva province without getting permission from the Provincial Health Authorities. Rules and regulations of the Sri Lankan Cosmetic Devices and Drugs Act clearly stipulate the conditions under which a pharmacy can be opened and operated. A youth with advanced level passes can never get permission to open a pharmacy. This is an impossibility.

The article goes on to refer to Prof Bibile’s concept and is described as one which came about 30 odd years ago when the country had a closed economy and the world including Sri Lanka was in a different era. What the readers should have been told is that Prof Bibile’s concept of limited list of Essential Medicines has been taken up by the World Health Organization (WHO). The first Essential Medicines List (EML) was published by the WHO in 1977. The EML has been regularly revised and updated every two years. The latest revision was in 2007 when the 15th Edition was published. The EML lists 350 essential drugs; it is used as a guideline by all countries that want to develop their own essential medicines list based on Bibile’s concept. The latest revision of the Sri Lankan EML was in 2007; it contains 340 essential medicines.

The biggest omission in the article, in my opinion, is that no reference was made to the Sri Lankan National Medicine Drug Policy (NMDP) based on Bibile’s concept of essential drugs. Any discussion, examination or analysis of issues related to generics and brands is incomplete without reference to the Sri Lankan NMDP. This is in the public domain. The World Health Organization (WHO) has posted the NMDP in its website http://www.who.int/medicines/areas/policy/NMDP_SriLanka.pdf This indicates the importance WHO attaches to the Sri Lankan policy document. The NMDP was formulated by participants at two workshops in 2005. The participants included representatives of all the stake holders including the Sri Lanka Medical Association (SLMA), the Independent Medical Practitioners Association, (IMPA), the Government Medical Officers Association (GMOA), the private sector pharmaceutical industry and trade, consumers, medical faculties and the Ministry of Health. The participants unanimously adopted the NMDP consensus. The major components of the NMDP included the following:

1. Selection of essential medicines. As mentioned earlier the latest revision of the Sri Lankan List of Essential Drugs was completed in 2007. It consists of 340 drugs.

2. Pricing policy/mechanism should be adopted to ensure affordability.

3. Legislation requiring generic prescribing and allowing cost-effective generic substitution with the consent of the patient and (when possible informing the doctor) should be enacted.

4. Medicines should be registered based on the criteria of quality, safety, efficacy, need and cost effectiveness.

5. These criteria should be established by the National Medicinal Drug Authority (NMDRA).

6. The NMDRA should have the authority to limit the number of new chemical entities of a particular class of drugs as well as the number of products of a particular chemical entity.

It needs to be reiterated that representatives of the SLMA, IMPA, GMOA and the private drug industry and trade agreed by consensus to the various components of the NMDP listed above.

The Minister of Health has appointed a National Standing Committee of 18 members representing all stake holder groups to oversee the implementation of the NMDP. A Draft Act to establish the National Medicinal Drug Authority is in the process of being finalised.

When the National Medicinal Drug Policy becomes fully operational, the Generic vs Brand issue will be solved and consumers will have regular access to safe and effective drugs of good quality at affordable prices. The question whether doctors should prescribe generic drugs or brand name drugs will cease to be a controversy.

K. Balasubramaniam, MBBS, PhD
Former Professor of Pharmacology
University of Peradeniya
Advisor and Co-ordinator, Health Action International Asia – Pacific

Our journalists’ reply:

Thank you, Dr. Balasubramaniam for your well-intentioned comments on the article. However, you seem to have missed the point of our article which was to depict the ground realities of the situation faced by practising doctors when it comes to prescribing any drug, whether generic or brand. We request you to go back and re-read our article, not cursorily but more carefully.The question of us not reading about generics and brands is totally out of context.

The article was based on extensive research and interviews carried out with a cross-section of not only doctors but also patients as well as officials of the health sector who are dealing with the issue on a day- to-day basis. It was not as you allege, based on anecdotes. With regard to “subjective” views of doctors, you fail to take into account that these doctors are in fact treating numerous patients and prescribing drugs, unlike experts who may have “objective” views but in fact do not come into contact with patients.

As to the number of pharmacies, which you say is “factually incorrect” we would like to ask you whether you have conducted a survey. If you have, then please show us the findings. The figure of 20,000 pharmacies was given to us by the GMOA.

Just because the Drug Regulatory Authority has only 3,000-3,100 on their books does not mean there aren’t unregistered pharmacies or pharmacies operating without a registered pharmacist. Take the parallel case of registered doctors. Although the Sri Lanka Medical Council has only 18,000 registered, there are an estimated 30,000 quacks operating as doctors in the country. A Sunday Times survey published last week revealed that of 40 pharmacies close to Colombo (the detailed list is with us) six did not or could not produce registration documents. Twenty pharmacies also did not have the registered pharmacists at that time though they were dispensing drugs.

Many regulations exist but whether those flouting them are brought to book is the issue. With regard to Prof. Bibile’s commendable efforts, is it not true that his concept came 30-odd years ago? A simple calculation will prove so. We reiterate that our statement that not only Sri Lanka but the world has changed is valid when taking into consideration globalisation and the IT revolution.

Dr. Balasubramaniam faults us for not mentioning the NMDP. This again was not the focus of our article, but Dr. Balasubramian has been economical with the truth because in fact we have quoted the GMOA Secretary on the NMDP, asking for its implementation.

It is regrettable that Dr. Balasubramaniam, while elaborating on the WHO-recommended EML (is it used by medical practitioners?) has failed to mention the lack of information both doctors and patients face at ground level and also the crucial issue of corruption. What we understand is that the EML was last revised in 2006 and some doctors got it only at the end of April 2008.

Why doesn’t Dr. Balasubramaniam’s NGO help the poor patients, as a first step, by supporting the authorities to get the outdated drug formulary and also the drug index updated and printed as a priority?