Veterinary Medicines Directorate Regulations (Awareness Creation) - Kenya Veterinary Association (KVA)

As of April 2018, KVA had been advocating the separation of the regulation of veterinary medicines from human medicine for some time.

In 2009 KVA undertook a research on veterinary medicines distribution. The research showed substantial misuse of veterinary medicines raising great public health concern and greatly hindering access to markets for livestock and livestock products which are rendered noncompliance with international standards. This made KVA propose reforms in the regulation of veterinary medicines (including importation, manufacturing, registration, distribution, storage and usage) as regulated by the Pharmacy and Poisons Act (Cap 244).

KVA initiated advocacy for a Veterinary Medicines legislation which was redrafted. The Veterinary Medicines Bill was published in 2010 but faced resistance from stakeholders in the pharmaceutical sector who wanted the status quo to prevail. This affected its progress leading to its expiry with the life of parliament in 2012.

The Veterinary Surgeons and Veterinary Para-professionals (VSVP) Bill was tabled and passed in parliament during the same time with KVA heavily influencing its enactment. VSVP provides for separate regulation of veterinary medicines upon establishment of a Veterinary Medicines Directorate (VMD) which is expected to ensure appropriate manufacture, importation, distribution and safe use of veterinary medicines.

In 2012, KVA undertook advocacy for the reintroduction of the Veterinary Medicines Bill and development of Veterinary Medicines Directorate (VMD) Regulations. In 2014 KVA undertook a Regulatory Impact Assessment (RIA) as a new requirement under the Statutory Instruments Act of 2013. The VMD Regulations were successfully gazetted in October 2015 and the VMD council gazetted in October 2016.

However, implementation VMD Regulations have faced resistance especially from the pharmaceutical industry. In November 2016 a petition by the Kenya Pharmaceutical Distributors Association (KPDA) representing pharmacists was filed to challenge the VMD Regulations and the VMD Council, grounds that:

  • some sections of the Veterinary Surgeon and Veterinary Para-professionals Act are unconstitutional;
  • the VMD Regulations are inconsistent with the Pharmacy and Poisons Act;
  • and that the Regulations were in breach of the Statutory Instruments Act and therefore unconstitutional. The case was dismissed by the Court on 29th Sep 2017 on the grounds that the issue was of great public interest as opposed to a narrow commercial interest of the pharmacists and the complaints made were not substantiated.

Currently, a majority of industry practitioners and stakeholders including veterinarians, para-veterinarians, pharmacists, pharmacy technologists, pharmaceutical manufacturers, importers of veterinary drugs, traders and consumers do not know the full implications of the regulatory arrangements. Consequently, compliance is still low.

KVA partnered with the VMD Council to create awareness of the new regulatory mechanisms of veterinary medicines among the industry practitioners and consumers to facilitate enforcement.

Expected Outcome

Creating awareness about the newly established Veterinary Medicines Directorate (VDM) and its role in the regulation of veterinary drugs is expected to facilitate a smooth transition from the Pharmacy and Poisons Board (PPB) and demystify the misperception about VMD.

Proper regulation of veterinary drugs will guarantee the safety of animal products and create access to the international markets for livestock or livestock products thus improve the contribution of the sector to GDP.

You can view a BAF impact assessment on this here Creating the Veterinary Medicines Directorate - an Impact Assessment