Parly okays overdue medical regulations

. . . days of rogue pharmarcies, health practices numbered

MATHATISI SEBUSI

MASERU – Health practitioners using medical devices and diagnostics equipment, along with pharmacies and laboratories should anticipate significant legal, regulatory and market changes beginning this year. These changes are expected to have a lasting impact on the industry. This is after the adoption by the National Assembly of the Medicines and Medical Devices Control Bill of 2019, which the medical sector says is long overdue. The sector is, however, hopeful that the law will address their concerns over the worrying number of mushrooming pharmacies and unregulated medical facilities and outlets offering medical services, with all and sundry acting as medical practitioners.

In an interview with Public Eye following these developments the president of the Pharmacy Association of Lesotho (PAL), Teliso Letsatsi, highlighted that because of non-existent medical regulation in the country, individuals have been opening pharmacies, selling and manufacturing medicines without any medical qualification allowing them to do so. He said this has not only put a lot of lives in danger, but has opened the floodgates for counterfeit medical products being imported into the country, along with other potentially dangerous ones that are being produced right here in the country.

Letsatsi also cited the risks posed by the sale of medication on the streets across towns in Lesotho claimed to cure particular aliments but only end up being dangerous to users. He said they have all along been forced to watch from the sidelines as there was no stopping anyone from selling medicines and medical products. He said without regulations, pharmacies owned by unqualified individuals have also been mushrooming around the country and continue to increase in alarming numbers.

“People do as they please in terms of selling pills, medicines and medical products and there is nothing we can do about it. Some are opening pharmacies without proper documentation and these do not only put people’s lives in danger but put the whole country at the risk of consuming forged products imported by foreigners into the country. We do not know if medicines sold on the black market are safe for human consumption or not,” he said.

Letsatsi revealed that they been pleading with all past governments for years to regulate the industry; enact laws that will restrict the sale of medical products by unregistered and unqualified persons. As much as he appreciates the Bill, he, however, warns the relevant portfolio committee to be aware of other medical professionals, that include but are not limited to doctors, nurses, dentists and veterinary doctors who are pushing for the Bill to serve their own personal interests.

Letsatsi stressed that pharmacists are the only legal custodians of medicines worldwide that are trained, among others, to ensure that the public is safe in consuming medication. He said this involves scrutinising prescriptions from other medical practitioners so that the drug is changed to have safer options before it is passed on to patients. Other health professionals are only allowed to prescribe medicines but are not the custody of medication.

The Portfolio Committee on the Social Cluster recommended passing of the Medicines and Medical Devices Control Authority Bill of 2019 by parliament this week. The Bill was itself tabled before parliament by the Minister of Health, Semano Sekatle, in December 2019. Sekatle says the purpose of the Bill is to establish a medicines regulatory authority which will be a statutory body responsible for regulating and controlling medicines and medical devices.

He says unregulated medicines result in the use of ineffective, poor quality and harmful medicines which can lead to therapeutic failure, exacerbation of diseases, and resistance to medicines which have adverse side effects on users, advertisement of medical products with false claims attached on their effects, malpractices in the medicines outlets and unauthorized trials.

The Bill aims to address these challenges by regulating and controlling manufacture, sale, distribution and use of medical products to ensure that such products meet the required standard of safety, efficacy as well as quality in order to protect public health. When enacted, all medical products will be registered, premises used for manufacturing and selling of medical products as well as personnel handling medical products will also be licensed.

However, the parliamentary committee has noted that the implementation of the Bill shall require some funds from government for setting up the authority’s offices and recruiting staff. Government will, in turn, collect revenue in the form of licenses issuance as well as registration of medical products.

“The government should speed up the establishment of the Bureau of Food Standards in order to have shelf life of food produced in the country. “The relevant ministry ought to establish one body governing the following: pharmacists, pharmacist technicians, nurses, assistant nurses, radiographers, assistant radiographers, labour technicians, optometrists, dentists, assistant dentists, urologists and ophthalmologists.”