Addressing challenges of substandard medical products

Essential medicines save lives and improve health when they are of assured quality, available, affordable and promptly used. Quality is a key word here.

The threat of accessing substandard and falsified medical products can lead to devastating consequences on families, health systems and the economy. When medicines do not work the way they should, they can prolong illness and in the worst case scenario people die. It is now a threat to global security and threatens to undermine progress towards achieving the Sustainable Development Goals (SDGs).

It is in this regard that Kenya has made a deliberate and pro-active decision to forge a solid defence mechanism to contain this threat. Since no country can fight this problem alone, our defence mechanism must act in unison at national, regional and global levels.

Recognition of this interconnectedness is the foundation of Kenya’s three-pronged approach; to contain substandard and falsified medical products as stated by His Excellency President Uhuru Kenyatta in the recent United Nations General Assembly’s side event on the fight for quality medicines in Africa.

Kenya’s broad reform agenda has triggered structural realignment across all sectors, through policy, legal and institutional reforms. These reforms are anchored on the Kenya Constitution 2010, which confers fundamental rights to citizens, including the right to the highest attainable standard of health, and the right of consumers to goods and services of acceptable standards.

Medical products

These rights cannot be attained without availability and access to safe, effective and quality medical devices. Therefore, fighting substandard and falsified medical products is a constitutional duty of the Government. Attaining the fundamental rights and freedoms relating to health require a bold reset of how we deliver health to our people.

That explains why the Government has prioritised Universal Health Coverage (UHC), as one of the “Big Four” agendas and committed to progressively increase the health budgetary allocation at national and county levels. As we revamp our health sector, we have placed special focus on the stewardship role of government.

Through the Health Act 2017, the government envisions a single but robust and effective regulatory authority for all health products and technologies.The restructuring of the medicines regulatory system to integrate standard-setting and enforcement for food, medicines, vaccines, devices, diagnostics and other health technologies has commenced.

This model is designed to enhance efficiency and collaboration in mitigating health risks that include substandard and falsified medical products informed by sound science and evidence. Indeed, a multi-agency team involving the health and trade sectors, anti-counterfeit, customs as well as security agencies are conducting a crackdown on this menace and I am confident that we shall overcome this problem.

Secure world

Additionally, Kenya is committed to supporting the work of regional, international and multilateral organizations in finding lasting solutions for a free and secure world. Kenya has, therefore, reiterated its support and commitment to the establishment of the Africa Medicines Agency (AMA) by the African Union.

Promoting access to medicines and health commodities alone is not sufficient. Mechanisms will be put in place to guarantee continuous compliance to acceptable quality standards. This requires that information on these standards is readily available to assist regulatory authorities in ensuring the information is available publicly.

Strengthening of the national supply chain of pharmaceuticals and non-pharmaceuticals through Kemsa is our priority and very much part of our roadmap to attaining UHC while addressing the challenge of poor quality products.

This will include Infrastructure enhancement to address any challenges along distribution channels like the provision of proper storage facilities and deployment of technologies.

My ministry will work with county governments to invest more on convergence and harmonization of our regulatory systems and contribute to mutual learning.

The international community on their part should consider making the needed resources available, to facilitate efforts in fostering technical and political convergence in the fight against substandard and falsified medical products.

Mrs Kariuki is the Cabinet Secretary, Ministry of Health