New regional pharmaceuticals regulator will not ban generic drugs
- GA-FDD Director
Director of the Government Analyst-Food and Drug Department (GA-FDD) Marlan Cole says the soon-to-be-established Caribbean Regulatory System (CRS) will not ban generic pharmaceuticals from entering Guyana but will in fact ensure that the drugs entering the country are approved as being of a high quality.
“How can we say that generic drugs would be banned when, for one, we cannot afford innovator or brand named drugs and most of the drugs used are generic? That would be foolish,” Cole told Stabroek News.
The GA-FDD Director was addressing a report in the Guyana Times newspaper, which stated that suppliers bringing generic medicines to these shores would see their products being banned from entry.
Former Minister of Health Dr Leslie Ramsammy has also complained that the CRS’ establishment will see suppliers having to get their pharmaceuticals certified by the agency as well as the GA-FDD before being distributed, which would not only see an increase in the price for drugs but a ban from the country.
“It will lead to a massive increase in the 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 medicine, healthcare will suffer,” Ramsammy wrote in a letter to the editor last week.
Positing that the Ministry of Public Health was abandoning a system that has worked well for Guyana for decades, Ramsammy said that the ministry was also ignoring a WHO-Prequalification System for Pharmaceuticals. The system, he maintained, was designed to assist countries in accessing safe, quality and affordable medicines. “WHOPrequalified 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,” Ramsammy stated.
“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 favour of medicines made by large companies in America, Canada, the UK and Australia,” he added.
But Cole said Ramsammy has his information very wrong.
Cole explained that the CRS will ensure that patients in Guyana and other Caricom countries will have access to generic drugs that are safe and of a high quality. The agency will serve as a support system here for the GA-FDD, he explained.
The CRS website states that the agency’s main purpose is to strengthen regulatory capacity in Caricom member states in support of improved access to safe, quality, efficacious, and affordable medicines and health technologies.
“The CRS strengthens regulatory capacities through the provision of registration and pharmacovigilance support to member states, using efficiencies, such as reliance on reference authorities, to enable a sustainable enterprise in the resource-constrained environment of small states. This contributes to CARPHA [Caribbean Public Health Agency]’s mandate to prevent diseases, promote health and respond to public health emergencies,” it adds.
Cole pointed out that over the years, there have been complaints by persons in the healthcare fields, in many Caricom countries, that there was limited resources to check the quality and efficacy of drugs brought in.
“What the region recognised is that per country, no one had the resources needed to check the drugs coming in. So it was decided that a hub be created and the CRS will look at drugs for all other region,” he noted.
“Even here at GA-FDD, we just don’t have the staffing, the ability or capability to concentrate our efforts... we have only three drug inspectors and mountains and mountains of documents every day. This is where CARPHA comes in, so after this we will get assistance with this backlog. They will carry out the research works to check various things, maybe the drugs’ buyer availability, check clinical trials and so forth…,” he added
According to Cole, generic drugs being imported that are not
innovator brand names or generics certified by WHO and other internationally recognised agencies, would have to be certified by CRS before entry.
This, he said, would ensure that drugs being brought from unknown manufacturers globally would be of patient-ready high quality and assist in curbing the importation of substandard and fake medicines.
He made reference to the cases here where generic drugs for the treatment of diabetes were used and because of poor efficacy were not helping patients. If there were a CRS, he said, the chances of this happening would have been lower.
Minister of Health Volda Lawrence signed a Memorandum of Understanding with CARPHA on March 3 this year, in keeping with commitments the former government had already made in 2014, to pave the way for the implementation of the CRS.
Lawrence was out of the country and could not defend government’s continuation of the Caricom agreement when this newspaper enquired but her spokesman Terrence Esseboom said she would when she returned.
A prospective supplier of generic drugs from companies not recognized or already certified, would submit their drug names to CRS and after its evaluation would be issued with certification to be taken to the GA-FDD and continue as per norm all other required processes.
Dr Rudolph Cummings, the Programme Manager of Health Sector Development at the Caricom Secretariat, was described by Cole as the best person to give a detailed rundown of the formation of the CRS and what it would mean for suppliers of pharmaceuticals here.
Cummings told Stabroek News that unlike what has been stated in some quarters, the CRS was not put in place to assist Guyana alone and the regulatory agency would ensure that countries in the Caribbean have essential but high quality generic medicines.
CARPHA, through collaborative efforts with the Caricom Secretariat and the WHO and PAHO, would be responsible for the setting up of the CRS. The Bill and Melinda Gates Foundation is also providing support to the agency.
Cummings explained, “The concept emanated because we have lots of chronic diseases and not enough access to low cost pharmaceuticals… A decision in 2014 by the ministers of health from various Caricom countries agreed that a mechanism to assess manufacturers for the quality of their products was a priority, within the portals of the region.”
He added, “Manufacturers who want to bid usually have to produce documents for the assessment of their product. The CRS is accessible to all Caricom member states and would serve as the regulatory body for importers of generic drugs that are not WHO-compliant or from the list of already registered and certified manufacturers, so that the products coming into the region meet international standards… so, say a manufacturer wants to be eligible for drugs previously not specified, let’s say 20 products, they have the opportunity to send the documentation to CRS… they would ensure that it meets therapeutic manufacturing standards before it could be sold.”