Bibile and the National Medicinal Drug Policy

28 September 2015 06:30 pm - 0     - {{hitsCtrl.values.hits}}

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         38th Death Anniversary of Professor Senaka Bibile          

First Mystery
The death occurred of  Prof. Senaka Bibile on September 29, 1977, at Gyana under mysterious circumstances. It is a well known ‘secret’ that Bibile, the architect of World Health Organisation endorsed Medicinal Drugs Formula/policy, the very essence of  which is on the needs of safety, efficacy, quality and also affordability and availability of drugs.

Professor Bibile, whose work benefitted the third world as he championed the use of generic name only by the profession, was put to death by inducing cardiac arrest using a drug by one of his own colleagues, hired by Big Pharma, following a few “we are watching you!” messages in real mafia fashion to ensure the continued ‘progress’ of multi-billion dollar disreputable business. 

Reading  Daily Mirror columnist Ranga Kalansuriya’s [RK]‘Open letter to Dr. Rajitha Senaratne - There is a medical mafia in operation,’ [25/09] motivated me to remind the readers a few more things about the  ‘medical mafia’ which is just an off-shoot of that huge invasive tree identified as Transnational Pharmaceutical Mafia, or ‘Big Pharma’  [a title coined by the medical journalist in the West], on which the Daily Mirror carried a comprehensive account by the writer exactly an year ago, on September 30.     The private hospitals, some consultants and local Pharma industry, that RK spoke of are just; if I may use Mafia-related slang, the ‘Capos, soldiers and associates’ of the Mafia family; either influenced by them or enrolled directly under their pay-sheet for aiding, abetting and encouraging their felony in poor nations, while the dominating  powers of the hierarchy, 

the ‘Bosses or Dons, Under-bosses,’ operate  only at transnational level.  Who is answerable for the life of 57 years old greatest medical benefactor of third world who made the supreme sacrifice on September 29, 1977, on behalf of victims of the Pharma/Medical Mafia?  

  “Constructive criticism was extremely important to streamline the drug policy draft bill”, said the then Health Minister in response to Prof. Lal Jayakoday of the Faculty of Medicine, Colombo, when the latter spotlighted many shortcomings in the draft bill’. It was none other than the President himself as Health Minister, who made the observation on June 10, 2014.   He further stated that to administer the National Medicinal Drugs policy a National Medicinal Drugs, Devices and Cosmetic Regulatory Authority NMDDCRA would be set up with the  objective to ensure the availability of safe, efficacious and quality medicinal drugs to the general public at affordable prices. All credit to the President, who took a keen interest as Health boss under trying circumstances.

‘Minister Sirisena stressed’, the news report continued,  ‘…that in keeping with the late Prof. Senaka Bibile’s policy, the authority would function as the central regulator for all matters involved in importing, manufacturing, distributing , storing, selling, exhibiting, disposing, transporting and registering of medicinal drugs.’  



Second Mystery
“Original National Drug Policy was stolen from the womb” – Maithriplala Sirisena 

Former  Minister said the original National Drugs Policy was stolen while it was in the womb and it had to be prepared for the second time.  He said they are now determined to make sure  that not only that the birth of the new guidelines and a procedure will take place without a hitch but will also be “a healthy and robust one”. He was speaking at a seminar in June last year, to obtain views on the National Medicinal Drug Policy.”  It has now been completed with the contribution of all stake holders. I am happy to be the Health Minister who did it because it was only restricted to discussions during the past 40 years,” Minister Sirisena boasted. 



Third Mystery   
Little they, the President and government knew that the duplicate draft, the new baby that was delivered at Diyavanna under the 100-day programme on February 5, was fertiled at Deans Road, and fathered by the Transnational Pharmaceutical Mafia, hence it was conceived outside the womb and happened to be an ‘Avajatha’, an illegitimate one.     

They bought-over Chief Legal Draft-woman to ‘mysteriously disappear’ the file as revealed by the President during election campaign; even more startling, they offered him a bribe while serving as Minister of Health, an amount adequate to, in his own words ‘nurture seven generations’. Present Minister openly declared the amount offered to him as Rs. 300 million.  Both remained tight-lipped about the offender; no surprise, the first under former regime, it is understood, but why not do it now? There is a host of institutions set for the purpose like, BC, CID, FCID or PRECIFAC, 


in fact they are busy recording statements from former corrupt  family rule: doesn’t it sound strange if not mysterious.



Brands vs Generics
Prof. Bibile along with his political colleague and  Communist Party Leader Dr. S. A. Wickremasinghe worked out an ‘essential medicines’ concept; a policy for the rational use of medicinal drugs, though the mafia attempted to make out an allegation using some local agents of the Transnationals, some medical specialists and politicians.  

The Health Ministry is said to be taking measures for the past so many years to curb the prices of drugs.  The main reason for the rise of prices is the use of brand names in prescribing of drugs, instead of generic names by doctors, one of the focal points in Bibile formula.  The discrepancy in prices between these two types is shocking.  The system should consider passing laws to make prescribing  only by generic names compulsory; in fact the GMOA has fully backed the use of generic names in prescription.

Powerful Pharma Mafia is behind the ruthless promotion of drugs under brand names.  Billions of Dollars are thrown  on promotional drives.  Immoral things are done openly, as well as covertly to preserve the brand image of medicines.   Use of the generic name will ease the burden placed on poor patients, who are compelled to spend stupendous amounts, merely to purchase drugs under their brand name.



Generic substitution
Following the loss of patent protection, branded pharmaceutical products lose its market share due to generic equivalents. While patent protection helps premium returns relating to pharmaceutical innovation in Research & Development, legislation grants the means for generic suppliers to launch copy products quickly once patent period has expired. Since generic manufacturers do not stand any costs in R&D investment, generics are priced at a considerable discount to branded options causing pressure on the price of the original branded product.   Liars;   in reality R&D mostly based on taxpayer-funded research at academic institutions, at no cost to big pharma.

Generic substitution will influence the pricing of drugs both pre and post-patent expiry. The ability to guard the originator product from generic substitution will mostly be determined by the volume and availability of the drug. It is clear that branded drugs cannot fight successfully on price with generics and, as a result the development of the generics business will have a considerable effect on pricing all through a product’s life. With a comparatively free market in USA, pricing policies are relatively stretchy. For Big Pharma the majority of the conflict alongside the effects of generic substitution is over once generics appear in the market. As such, their  pricing policies focus on exploiting pre-patent expiry returns and then rely upon an established brand name to hang on to top market share succeeding patent expiry. 



The 100-day NMDP bill 
Then in the Rajapaksa era, some mysterious force enticed by the Transnational Pharma Mafia prevented the implementation of NMDP blaming it on the then Health Minister Sirisena, who made a genuine attempt to initiate it.  The NMDP Bill was made an Act after passing through the legislature in a faulty manner; it could spoil all medical processes and wipe out the entire health system.  The Ministry failed to seek the consent of all stake-holders to guarantee the compliance of the Bill before it was read in the parliament for legalisation.  Former Chairman of NATA [National Authority on Tobacco and Alcohol] and President of the Sri Lanka Medical Council (SLMC) had to ridicule it as totally inappropriate compared to Bibile principles, and shamed the proposals as a mockery of Senaka Bibile Principles, and that where the model of necessary medicines had not been spoken of.

The enactment was highly anticipated by the sick that waited to see a ‘quality drug at affordable price’.  Many in the profession had been reliably informed of the defects in the Act; they say it was not in harmony with the Bibile Principles. The Act had been drafted far short of the specific structure for the proposed institution.  “There was neither a concept nor a mechanism for quality control nor a regulatory mechanism” claimed, Prof Carlo Fonseka. The Peoples Movement for the Rights of Patients (PMRP) and GMOA uttered similar doubts as well. They pointed out the absence of a supervisory device for the authority to make judgment a serious misdemeanor.
 

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