Fri, 01 Jul 2022 Today's Paper

Why the new Drugs regulatory Act places ordinary folk in danger

24 November 2015 06:30 pm - 0     - {{hitsCtrl.values.hits}}

A A A




The writer is the appointed Attorney-at-law representing the Sri Lanka Chamber of the Pharmaceutical Industry’s Secretariat. This article is by way of Right of Reply, to the many articles that have appeared in the Dailymirror that the above organization contends, has misrepresented the interests of patients, and other health sector stakeholders.  



Patients do not know just how much they have been short-changed due to the short-sighted policy of a drug regulatory mechanism that was hastily rushed through Parliament, without proper consultation of the stakeholders.

They are the losers, and if health is wealth, they are losing their wealth twice over, once as patients who do not get the proper curative treatment, and once more as consumers of absurdly expensive, but perhaps useless drugs.

All this is due to the patent absurdities that are the veritable trademark aspect of the new NMRA, or National Medicinal Regulatory Authority Act.
The new Regulatory Act, on the one hand makes the doctor irrelevant and the pharmacist the ‘authority’, or the final arbiter (God?) in determining which drugs should be given to the patient. (Refer 56 (4) of[1]  the NMRA Act which states that when the brand name which is in the prescription is not available or affordable -- just who decides on affordability and upon what criteria? -- to the customer, the pharmacist may dispense any other generic medication with the consent of the customer ...)

In this country most pharmacies do not employ qualified pharmacists, a fact acknowledged by the Chairman of the NMRA. Shop Assistants with hardly any knowledge of English quite apart from medical knowledge, usually do the honours of dispensing drugs. 

The patient is deprived of the doctor’s prescribed remedy, and is forced to make do with a dubious alternative. The patient-doctor relationship, or the vital nexus of trust between patient and doctor is also breached, and this could lead to frustration for the patient, when a doctor inevitably takes the position that there can be no cure without the proper, prescribed medicine that he wrote out for the patient. It remains a home-truth that the best doctor would be of little value without good medicines 

Added to this, Section 56([2] 6) of the Act states that the pharmacist commits an offence if he or she fails to disclose the generic names available for a prescribed drug, with or without brand names. 

In the first place this stipulation is mostly observed in the breach, but when it is observed at all, the patient is presented with an array of drugs which he has absolutely no idea about, and which he is told is ‘equivalent’ to what the doctor prescribed. Is he equipped to choose? Not even the educated consumer of drugs would have a clue upon this aspect.

If the stakeholders in the pharmaceutical industry, the Pharmaceutical Chambers and practicing Consultant Colleges were consulted when the legislation was drafted for the NMRA, all of this which now impacts very negatively on the patients, could have been avoided.

It seems however, that there could be more dangerous results ahead for the patient. Certain powers-that-be promise at various public fora that generic drugs and ONLY generic drugs could be prescribed after a certain near day in the future (three years it has been said ...) , by medical practitioners.

They say this is the position in the United States and the United Kingdom, which is furthest from the truth.

Those who opt out (there are very many) of State sponsored health Insurance and other health related endeavors in these countries pay the Private Practitioners whatever they charge for consultation, and get branded medicines which are readily available at Pharmacies prescribed by their doctors 
Those who are in State Sponsored or State Affiliated programs however, such as the NHS in Britain, are prescribed generic drugs. This same situation prevails in the State Sector Hospitals where prescription is only by generic names, and there remains no choice for the patient who gets his medicine free.

There is also a situation in which some patients in certain countries (emphasis on some) cannot go to a doctor of their choice in order to benefit from the insurance schemes. But many Sri Lankans still have the option to be treated by a doctor of their choice.

To foreclose their option to be prescribed medicines determined by the doctor -- branded medicines -- citing the example of UK and the U.S. would be wrong at many levels and thoroughly misleading, the most important of which is that it is wrong to say that generics are prescribed to all patients in the said countries, as shown above.

In particular, the new NMRA legislation allegedly does immense disservice to certain types of patients, for example those who are afflicted with certain life threatening diseases.

The new legislation has it (at Section 118.[3] 3) that the Authority shall register New Chemical Entities on consideration of cost effectiveness. 

Particularly in the case of new life threatening illnesses, the new drugs available in the international markets may be deemed expensive, as they may carry a relatively high price tag considering the medical research that has gone into producing them, and the costs incurred therein.

It would be virtually impossible to carry out such Pharmo Economic studies in Sri Lanka to determine the cost effectiveness of these new chemical entities, and if on the other hand drugs are not registered based on arbitrarily and capriciously determined ‘cost effectiveness criteria’, patients suffering from life threatening diseases who can pay for new drugs in the market, and are willing to do so, would be deprived of these medicines.

This would effectively have the Drug Regulators playing God, and Sri Lanka starved of new and effective medicines.Would not a question of morality arise here?
As far as drug evaluation for registration purposes is considered, the new NMRA legislation is riddled with contradictions.

Section 47 2(a) of[4]  the new legislation stipulates that the general guidelines for drug evaluation among other things includes recommendations issued by the WHO.

However, section 47(3) of[5]  the same legislation stipulates that drug registration takes into consideration efficacy, safety, quality and need and costs of each medicine.

But even a cursory perusal of the WHO guidelines makes it clear that price is not a WHO guideline in registering medicines, while need could be very subjective, and is not a WHO guideline either.

These glaring contradictions in the legislation shows that the NMRA has been hastily put together, and suffers from not having the proper input from the relevant stakeholders, including those in the Pharmaceutical Industry, and also the respective Colleges of Medicines.. The patient suffers as a result, and is faced with a paucity of efficacious drugs in the market, while also having to contend with possibly with more expensive drugs in the market as a result of interference with regular market forces.

There are other anomalies which have been seen in the implementation of the NMRA, such as for example an individual over sixty five years of age being appointed the CEO of the new Authority. The Act however states emphatically that the CEO shall be a public officer, which begs the question, how did a 65+ individual qualify as a public officer?

Also, the National Advisory Committee which replaces the Technical Advisory Committee which existed under the earlier arrangement, has included a person from the Patient’s Rights movement and also ludicrously a Member from the Senaka Bibile Commemoration Committee,) as per the new legislation. How could what is effectively a technical Body which is the apex authority in determining critical Health /Pharmaceutical/issues, include lay persons? Would it be unreasonable to assume that the contents of the NMR Act have been doctored and manipulated by interested individuals ?

It seems the new legislation has been hastily packaged and rammed through the legislature for ideological reasons i.e.. ‘the politics of a fair and equitable drugs policy’ which in actual practice sadly translates as legislation which keeps good drugs away from the reach of the people, and makes patients unwilling guinea pigs in the operation of a new ‘fair and equitable’ drugs ‘fantasy’, as indicated in the facts set out above.



 
Order Gifts to Sri Lanka. See Kapruka's top selling online shopping categories such as Toys, Vegetables, Grocery, Flowers, Birthday Cakes, Fruits, Chocolates, Clothing and Electronics. Also see Kapruka's unique online services such as Money Remittence,News, Courier/Delivery, Food Delivery and over 700 top brands. Also get products from Amazon & Ebay via Kapruka Gloabal Shop into Sri Lanka.

Sell your vehicle & house fast with hitad.lk only cost is Rs.400, Advertise in Hitad.lk for free to sell your mobile phone. Want to sell your Pet, Advertise for Free in hitad.lk Search for Houses in Sri Lanka and find the best place through Hitad.lk find your best tuition place. Find the best partner for you, visit hitad.lk Find anything at any time hitad.lk.

  Comments - 0

Order Gifts to Sri Lanka. See Kapruka's top selling online shopping categories such as Toys, Vegetables, Grocery, Flowers, Birthday Cakes, Fruits, Chocolates, Clothing and Electronics. Also see Kapruka's unique online services such as Money Remittence,News, Courier/Delivery, Food Delivery and over 700 top brands. Also get products from Amazon & Ebay via Kapruka Gloabal Shop into Sri Lanka.

 

Sell your vehicle & house fast with hitad.lk only cost is Rs.400, Advertise in Hitad.lk for free to sell your mobile phone. Want to sell your Pet, Advertise for Free in hitad.lk Search for Houses in Sri Lanka and find the best place through Hitad.lk find your best tuition place. Find the best partner for you, visit hitad.lk Find anything at any time hitad.lk.


Add comment

Comments will be edited (grammar, spelling and slang) and authorized at the discretion of Daily Mirror online. The website also has the right not to publish selected comments.

Reply To:

Name - Reply Comment




Order Gifts to Sri Lanka. See Kapruka's top selling online shopping categories such as Toys, Vegetables, Grocery, Flowers, Birthday Cakes, Fruits, Chocolates, Clothing and Electronics. Also see Kapruka's unique online services such as Money Remittence,News, Courier/Delivery, Food Delivery and over 700 top brands. Also get products from Amazon & Ebay via Kapruka Gloabal Shop into Sri Lanka.

 

Sell your vehicle & house fast with hitad.lk only cost is Rs.400, Advertise in Hitad.lk for free to sell your mobile phone. Want to sell your Pet, Advertise for Free in hitad.lk Search for Houses in Sri Lanka and find the best place through Hitad.lk find your best tuition place. Find the best partner for you, visit hitad.lk Find anything at any time hitad.lk.