Global body drags President Ruto, CS Nakhumicha into feud over drugs Bill
PSK president Dr Louis Machogu (centre) and other pharmacists during a past press briefing. The KDA Bill has been amended to capture pharmacists and pharmaceutical technologists.
What you need to know:
- The Bill proposes the formation of an authority whose name is also contentious.
- Pharmacists, veterinary doctors and Kenya Pharmaceutical Technologists in verbal war over the proposed new law.
Never before has a Bill on health in the National Assembly generated so much controversy, including internationally, in recent times, like the Kenya Drugs Authority Bill, 2022.
The Bill, which has been reviewed by the Health Committee that has proposed numerous amendments, will lead to the formation of an authority, whose name, too, is contentious.
In its current form, the Bill proposes the body is named the Kenya Drug Authority (KDA), but the Ministry of Health recommends its renamed- and the committee is in concurrence with the proposed name — Kenya Health Products and Technologies Regulatory Authority.
The authority would be responsible for protecting public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices and the food supply among others.
The Bill has generated a lot of professional and public interest locally and internationally.
The International Pharmaceutical Federation (FIP) has written an open letter to President William Ruto, Cabinet Secretary for Health Susan Nakhumicha and the National Assembly expressing its concerns about the Bill.
“We write to you out of deep concern for the proposed changes to the KDA Bill, changes that we believe pose a significant threat to patient safety, public health and overall quality of health care services in Kenya,” said FIP in a letter signed by President Paul Sinclair, Dr Prosper Hiag (vice-president) and Dr Catherine Duggan chief executive officer.
“Specifically, we wish to draw your attention to three key aspects of the proposed amendments which include the removal of veterinary products from KDA regulation, the granting of technical representative practice licences to undertrained technicians and the allowance for technicians to handle all scheduled medicines,” adds the letter dated October 24.
But what is the bone of contention?
The landmark Bill proposes to merge the regulation of animal and human medicines under the proposed authority.
This has opened old professional wounds, verbal war and a supremacy battle of learned medical friends in social media.
The Bill’s main protagonists that have opened a three-pronged vicious attack include pharmacists, veterinary doctors and the more than 12,000 Kenya Pharmaceutical Technologists (KPA) under the umbrella of the Kenya Pharmaceutical Association.
The technologists are accusing pharmacists of “professionally bullying” them and want to be treated as equals to pharmacists.
“The MPs should support the Bill without any amendments to ensure health is disseminated evenly in all the 47 counties,” argued KPA Secretary General Eric Gichane.
However, Pharmaceutical Society of Kenya (PSK) officials accuse pharmaceutical technologists of deliberately drifting the conversations away from the true issues.
“The push by pharmaceutical technologists to be treated as equals to pharmacists in the Bill is unconstitutional,” said Dr Elizabeth Ominde-Ogaja who is also a lecturer at Kabarak University.
The don who is one of the pioneer pharmacists at the University of Nairobi said that equating a pharmacist with a pharmaceutical technologist is extremely myopic.
“It does not happen in other professions like law, engineering, teaching among others. Pharmacists require a high degree of training, competence, and integrity,” said Dr Ogaja.
Dr Ogaja pointed out that KDA Bill must maintain standards for the benefit of all patients.
“We must have an authority manned by staff with a certain level of scientific expertise that can handle medicine and technologies that we’re using in the 21st century,” said Dr Ogaja.
Dr Lydia Momanyi-a clinical pharmacist in Nakuru County said currently Kenya is rated at Maturity Level 1 status according to the World Health Organisation (WHO) global benchmarking tool.
Kenya is playing in the same league with Somalia, Burundi, and Uganda among others.
“This means Kenya is not able to export locally produced health products and technologies,” said Dr Momanyi.
In order for Kenya to be accredited to manufacture health products and commodities like vaccines, it is required to strengthen its regulatory systems to achieve a Maturity Level 3.
“To catch up with the rest of the countries and attain WHO ML3, Kenya must have enough trained pharmacists handling the production of these health products and conducting research,” said Dr Momanyi.
Dr Momanyi observed that achieving ML3 will unlock Kenya’s export potential in pharmaceutical manufacturing and will boost confidence in the quality of Kenya’s pharmaceutical exports in regional and international markets.
She said with the increase of various cancers, a pharmacist is emerging as a key player in identifying these symptoms.
In addition to dispensing drugs, pharmacists play the role of medication counseling and providing drug information and family planning methods.
“The pharmaceutical technology training of three years is not comparable to the pharmacists training which is about six years,” she added.
Vets argue that the current bill wants to take away veterinary drugs from the Ministry of Agriculture to the Ministry of Health.
“We do not have veterinarians in the Ministry of Health because veterinary diseases are dealt with by veterinary surgeons and veterinary specialists,” argued Dr Maurice Ogutu, the technical chairman of the Veterinary Inputs Suppliers Association of Kenya.
The more than 4,000 registered pharmacists under the umbrella of the PSK argue that vets are not trained in pharmaceutical chemistry or pharmaceutical analysis, because all that is done by pharmacists.
“I wish to support very strongly the retention of Veterinary pharmaceuticals in the KDA Bill. Professionally, a pharmacist is the most qualified person who is deliberately, holistically, and intentionally trained in all pharmaceuticals,” added Dr Ogaja.
Experts argue that the fighting may not be about professionalism but the control of the multi-billion shillings export value of pharmaceutical products in Kenya which amounted to a value of roughly Sh3.3 billion in the third quarter of 2021.
However, PSK dismisses this line of argument. The intensified lobbying is set to go a notch higher after the National Assembly Health Committee made its final amendments and is expected to present the Bill to the Assembly for debate anytime now.
The pharmaceutical technologies and vets seems to have the last laugh as the amendments proposed by the National Health Committee led by Endebess MP Robert Pukosey seem to favour their proosals to the Bill.
“The Bill has 97 clauses and we have considered clauses and made our recommendations to be adopted by the National Assembly,” said Dr Pukosey.
The National Assembly Health Committee made a raft of changes in the Bill. The Bill will capture both cadres in pharmacy practice – pharmacists and pharmaceutical technologists. The vets will not be under the KDA.
“The Bill should only concern itself with human health products and technologies. Vet services will not be in the Bill,” read one of the amendments.
The pharmaceutical technologists according to the Bill amendments will be treated on equal terms like the pharmacists.
At the same time the pharmaceutical technologists won the battle to control scheduled medicines and have been given a leeway to administer them.
Another amendment that was a blow to pharmacists in the amended Bill include inclusion of pharmacists and pharmaceutical technologists in wholesale dealership in medicines and health technologies.
If it gets the members nod it will land at President Ruto’s desk at State House for signing into law or he may return it to the assembly with his own amendments after consultation with his advisers.
The Health committee amendments may be the last nail in the coffin of this controversial debate.
