Do the ‘African Lions’ appreciate the importance of medical products regulation?

Swithin J Munyantwali, IBA Fellow

About the IBA Fellowship for Innovation

As I observed in a previous article for the IBA, numerous respected commentators applaud the promise of economic development in Africa. This has resulted in complimentary phrases, such as 'lions on the move' coined by McKinsey and the continent being compared to the Asian Tigers, who have rapidly moved from third to first world status.

This article focuses on healthcare, an important indicator of well-being in any society, and assesses whether the ‘African Lions’ meet the legal requirements to deliver dependable and acceptable care to the populations currently living on the continent.  The general failure of a robust regulatory framework in a country is usually indicative of failure to regulate in a specific context.

Having access to regular and high-quality medical care is a basic human right.  As an individual living on the African continent, I am constantly struck by the poor or almost non-existent access to any kind of normal medical services. A substantial part of the problem is the lack of solid legal regimes to regulate medicine and pharmaceutical products.

A legal regime that does fails to do this risks the well-being of current and future African generations.

The single largest crisis facing Sub-Saharan Africa

As previously indicated, the view of the most respected Africa observers is that Sub-Saharan Africa is the next frontier for development.

Subsequently, it is expected that Africa will take its place as an increasingly influential and important driver in global affairs.

With almost 200m people aged between 15 and 24, Africa is perched upon unbridled potential. Any observer of the efforts by the private sector and civil society will witness a credible effort for Africa and Africans to be globally competitive across all sectors. This is evident in the impressive strides in sectors such as telecoms where the ability to move money across mobile phones has led to a financial and technological revolution giving access of most citizenry to access heretofore unavailable basic financial services.

But the promise of a youthful population capable of effectively contributing to the continent’s growth is contingent upon, amongst other things, systemic access to high-quality goods and services that facilitate the universally recognised rights of access to health and well-being, education, and opportunities for gainful employment.

However, all current indications (with the exception of South Africa, and a few states in the Southern African region) point to the chronic lack of access to healthcare. Many would argue that this is the single largest crisis facing Sub-Saharan Africa.  

According to a 2012 report published by KPMG entitled The State of Healthcare in Africa, 65 percent of all deaths in Africa are attributed to communicable diseases, maternal and perinatal conditions and nutritional deficiencies (of which 63.7 per cent are infectious and parasitic diseases), compared to only 27.5 per cent credited to such causes worldwide.

Given the high percentage of deaths attributable to largely preventable illness, it is no coincidence that Africa has the lowest life expectancy of any region as classified by the World Health Organisation (WHO) at 54 years, compared to 65 in Southeast Asia and 76 in the Americas.

A simple visit to most countries in the region clearly demonstrates the magnitude of the crisis, validating the statistics. For example, African markets are flooded with counterfeit and substandard medicines and pharmaceutical manufacturers, and yet regulatory systems across the region are ill-equipped to detect these substandard and counterfeit medicines and remove them from the market – one observer familiar with this sector indicated that in some countries, the entry of medicine and other pharmaceutical products is completely unimpeded.

The chronic corruption in many states facilitates this status quo. In most cases policies preventing the sale and distribution of these products are lacking or simply not enforced. The poor quality of medications can result in drug-resistant forms of diseases, and ultimately, inflict a serious strain on the economy. 

While most African countries have existing legal and regulatory frameworks that provide for a national medicines regulatory authority (NMRA), they frequently suffer from regulatory gaps and overlaps, leading to confusion.

Most NMRAs face uncertainty in sustainable financing as well as a lack of qualified staff and operational resources. While several countries have legal procedures for the registration of medicines, they are generally not consistent with WHO or recognisable international best practice standards.

African countries are often characterised by limited import and export controls, poor coordination amongst authorities responsible for licensing and inspection, limited quality control capabilities and poor implementation of post-marketing surveillance.

To put this in context, many other sectors of our economies, such as viable and credible education systems, suffer from the same level of inefficiency: a clear indication of continuing incompetence in the management of important national affairs.

Notwithstanding the challenges, important strides are being made in the regulation of medicines and should be built upon. A notable effort is the African Union’s (AU) promulgation of the Model Law on Medical Product Regulation.

There is an urgent need by member states in the region to own the process of domesticating the Model Law. This requires African countries to assess their own regulatory systems and address gaps and work towards communication, harmonisation and a cooperative response in the regulation of medicines across the continent.

These efforts should go hand-in-hand with efforts to strengthen management systems and institutional capacity of NMRAs and the establishment of joint platforms for coordination and enhanced enforcement. As demonstrated in other parts of the developing world, strengthened access to quality medicines and improvements to basic healthcare delivery has the potential to drastically address Africa’s health crisis, and bring to reality the promise of economic and other development empowerment.

What can African countries do to ensure effective regulation?

Political will to recognise that a problem exists

In the 1980’s, the Ugandan Government recognized that the HIV/AIDS crisis was a national emergency that threatened to cripple the well-being of Ugandan citizens and subsequently its economy.

Following this, the Government began a national sensitisation campaign which was nationally owned, and with support of the international community. Within the following years the rate of infection drastically dropped, and the country was held out as a global model to fight the scourge.

A similar effort must be expended to address the current crisis.

Marshall all relevant institutions to reverse the current trend

In addressing the problem, there is no need for African countries to ‘reinvent the wheel’. There are many established countries the world over who can provide lessons of experience for Africa to develop its own unique model to address the challenge of inadequate medical and pharmaceutical regulation.

Ultimately, bringing together the following institutions to establish a coherent and time-sensitive plan for reform would be a credible first step:

NMRAs; private drug and pharmaceutical manufacturers and distributors; health professionals; relevant parliamentary committees, including, for example, those responsible for health legislation and finance; representatives from ministries of justice and law reform commissions responsible for the drafting of legislation; relevant civil society and media, responsible for public awareness and advocacy; national standards bureaus; related experts from academia, research institutions and professional associations; consumer associations/consumers; police; customs officials; and other relevant justice, law and order sector institutions.

The consultative meetings will seek to develop national awareness and buy-in for the requirements set forth in the Model Law for Medical Product Regulation and the respective implications for each of the relevant authorities. This will be of key relevance at the time of implementation and will ensure institutional accountability and advocacy. The Parties will seek the participation of the African Union’s New Partnership for Africa’s Development (NEPAD) African Medicines Regulatory Harmonisation Programme and its relevant established Regional Centres of Regulatory Excellence.

The participation of enforcement agencies, including police, customs and other justice, law and order sector institutions, will form a key part of the consultative process. The interface between NMRAs and enforcement agencies, facilitated through this intervention, will be pivotal in ensuring effective inspection of medical products at ports and other points of entry and distribution, detection and investigation of individuals involved in illegal trade and counterfeiting of medical products, and systematized apprehension and prosecution of criminals.

Assessing Legal and Regulatory Framework

Following the convening of relevant stakeholders, carry out an assessment of the existing legal and regulatory framework in each country, establish buy-in for enhanced medical regulation amongst key stakeholders.  Subsequently, provide the relevant support towards development of a legal and regulatory framework in line with the Model Law on Medical Product Regulation, and pursue widespread sensitization of relevant stakeholders on the socio-economic implications of the draft law.

Regionalisation

It is hoped that the aforementioned national efforts would be discussed at the level of regional economic communities to ensure that there is harmonization of legislation so that those involved in importation of medicine and pharmaceutical products are operating in a predicable region, devoid of inconsistent procedures. This will facilitate acceptable trade and investment in an increasingly interconnected region. Naturally, technical assistance should be provided to important constituencies such as representatives from Ministries of Justice/Law Reform Commissions in each of the target countries, assisting them to domesticate the Model Law on Medical Product Regulation in light of local needs, conditions and the existing legal and regulatory framework.

Consensus-Building within National Parliaments

With reference to the NEPAD African Medicines Regulatory Harmonisation Programme, there would be a need for national workshops to help private drug and pharmaceutical manufacturers and distributors to effectively sensitize and build consensus within national parliaments in the passage of the domesticated draft law on medical product regulation. This would ensure that the socio-economic implications of the draft law are well understood by parliamentarians, a key constituency in the law reform process.

The following would result from such a process:

  • Strengthened buy-in for medical product regulation amongst key stakeholders;
  • Enhanced cooperation between NMRAs and justice, law and order sector institutions charged with enforcement of medical product regulation;
  • Domesticated draft legislation across affected Sub-Saharan countries — harmonized with the AU Model Law on Medical Product Legislation; and
  • Parliamentarians are sensitized as to the socio-economic implications of the domesticated draft legislation for medical product regulation.

Swithin J Munyantwali is Vice-Chair of the African Centre for Legal Excellence. He is one of three Fellows under the IBA’s newly inaugurated Fellowship for Innovation programme