…says sinister moves afoot in the pharmaceutical sector
Below is a commentary by Dr Leslie Ramsammy, a former Health Minister, on the Food and Drug Analyst Department’s recent pronouncement that the body will only register medicines for entry into Guyana, which are already registered in America, Canada, the UK and Australia:
Something sinister is happening at the Food and Drug Analyst Department and it will affect ALL GUYANESE. It will lead to massive increases in cost of medicines and supplies in the public health system, a cost that will be borne by taxpayers. Government will have to spend more on medicines, but will receive less, leading to sustained shortages in the public health system. But it will also lead to higher cost of medicines in the private health system. Without full access to medicines healthcare will suffer.
At a special meeting held by the Ministry of Public Health at the regency Suite last week, the Director of the Food and Drug Analyst Department, Marlan Cole, informed suppliers that the department will only register medicines for entry into Guyana, which are already registered in America, Canada, the UK and Australia, banning generic medicines from India and other countries.
This policy change dismisses the World Health Organization (WHO), the world’s premier health organization, and the UN, UNFPA, UNICEF, UNAIDS etc. which have assisted countries around the world to procure safe, quality medicines through the WHO Pre-Qualification System, medicines mostly not registered in America, Canada, the UK and Australia.
At the meeting, at the Head Table, were the Permanent Secretary and the Deputy Permanent Secretary of the Ministry of Public Health, the Head of the Food and Drug Analyst Department, Mr. Marlon Cole, Ms. Carolyn Healy of the USAID Global Health Supply Chain and other Ministry of Public Health officials. It is interesting that the USAID was present at the head table. The US has increased its production of generic medicines to compete with India and other countries.
This new architecture will effectively favor one company. Need a clue which of the existing suppliers will benefit? Think of the $606M GPHC scandal. Is the new pharmaceutical procurement system designed to benefit one company? You judge.
The Ministry of Public Health is abandoning a system that has worked well for Guyana for decades. It is ignoring that WHO-Prequalification System for Pharmaceuticals was designed to assist countries in accessing safe, quality, affordable medicines.
WHO-Prequalified medicines are used in all developing countries and several developed countries. But most of the WHO-Pre-qualified medicines are NOT registered in America, Canada, the UK and Australia. These medicines have saved millions of lives and prevented morbidity and disability for hundreds of millions of people around the world.
Importantly, these medicines have saved thousands of lives and prevented hundreds of thousands of morbidity and disability events in Guyana. These medicines are presently found in all public health institutions and in all private hospitals and private pharmacies in Guyana today. They will now be banned in favor of medicines made by large companies in America, Canada, the UK and Australia.
The majority of generic medicines, especially from India, Brazil, China, a number of European countries will now be banned from entering Guyana. Only expensive brand name medicines will be allowed into Guyana. By design this new policy benefits Ansa McAl since this Trinidadian-based company represents several branded drug companies selling their products at exorbitant prices which was publicly exposed in the recent GPHC sole-sourcing fiasco. For reference, GPHC paid $606M for medicines which could have been procured from WHO-Prequalified Companies for about $200M.
Some of the Indian generic companies, like CIPLA, RANBAXXY, AUROBINDO, and several others have become the world’s pharmacy. They supply medicines to all countries in Asia, Africa, the Caribbean, South America and most of Europe. These companies are WHO-Pre-Qualified and their medicines have successfully undergone scrutiny for safety and quality. Notably, most of the active ingredients in medicines, manufactured in developing and developed countries, come from Indian companies.
Not registering a generic medicine in America does not automatically mean that these medicines are inferior. If this were so, these medicines would not have been pre-qualified by the WHO. For many non-US, non-Canada, non-UK generic companies, the high cost of meeting the barrage of ever changing import barriers designed to protect American, Canadian, British pharmaceutical companies make marketing low-cost medicines in those markets uneconomical. It is noteworthy that citizens from America, Canada, the UK, Europe and other countries travel to India to procure medicines because they cannot afford to purchase these medicines in their own countries.
The Food and Drug Analyst Department Head explained that his department wants “Mercedes and not Tata”, comparing medicines from America, Canada, and the UK to medicines coming from India. Has he forgotten that when we could not procure HIV medicines from America, Canada and the UK for $US15,000 per patient per year, thousands of lives were saved in Guyana because of WHO-Approved Medicines for under $US300 per year? In fact, today, more than 80% of the patients on HIV, TB and Malaria, diabetes and blood pressure treatment around the world are treated with WHO-Prequalified medicines supplied by Indian generic manufacturers and these medicines are not registered in America, the UK, Canada or Australia. He should also know that Tata today owns and exports brands such as Jaguar and Land Rover to more than 150 countries.
In fact, the only documented counterfeit medicines in Guyana in the last decade were malaria medicines which were imported into Guyana from non-WHO-Prequalified Companies and the diabetes medicine metformin which was imported into Guyana from a generic company in Canada. Cole needs to provide evidence of the “massive amount of fake medicines” that came from India, China and other countries and identify the suppliers that brought these products into the country.
I urge the government to review this change in policy since Guyana is going in the opposite direction that most countries, including developed countries, are now going. In all these countries preference is given to generic medicines. Requiring imported medicines to be registered in America, Canada and the UK is a regressive move to stack the deck in favor of one supplier.
Dr. Leslie Ramsammy