Address drug makers set up hurdles

Recent pandemics, including the Covid-19 have triggered the calls for deglobalisation in the production of medical products to ensure these products are made closer to where the need is.

Africa, like many other regions, has seen renewed calls for local manufacturing of medical products. These calls have attracted the attention of the highest political players, with several African presidents and heads of government calling for acceleration of plans toward self-sufficiency of Africa starting with vaccines, perhaps because of the lessons from the Covid-19 pandemic.

Besides the political voices, Africa Union agencies have taken practical steps towards this goal. At this point, it is crucial to take note that the idea for local manufacturing has been in place since 2007 when Africa Union established the Pharmaceutical Manufacturing Plan for Africa (PMPA).

To fully realise this goal, we need to look at various enabling factors that need to be addressed to enable sustainable journey towards local manufacturing of medical products in Africa.

First, the place and role for mutual, beneficial partnerships including but not limited to overseas companies and organisations is crucial.

The coexistence of global, regional and local manufacturers provides the necessary synergies to stimulate the development of the pharmaceutical industry in general.

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Anecdotal evidence shows that markets which have good mix and coexistence of research and development [R&D] based, and overseas manufacturers tend to have better developed local manufacturing ecosystem.

Under these types of partnerships, the local manufacturers benefit from among other factors the early introduction of latest medical technologies, expansion of medical education opportunities, likely passive technology transfer if not specific active bilateral initiatives.

As such it is important to cultivate partnerships across all levels of manufacturers and identify areas of mutual benefit including tech transfer initiatives, voluntary licensing among others.

One important player in this co-existence beyond the industry remains the government through various policies that should encourage such co-existence especially with recent unilateral calls for near total localisation of pharmaceutical manufacturing, a situation which could harm the local manufacturers more than benefit them in the long run.

In the regulatory front, the last decade of harmonisation and convergence of regulatory requirements and the events and efforts culminating to Africa Medicines Agency (AMA) through the Africa medicines Regulatory Harmonisation (AMRH) initiative have presented a unique opportunity to local pharmaceutical production.

The outcome has been the progressive strengthening of medical products regulatory systems. Introduction and presence of well-developed alternative regulatory pathways presents an opportunity for local producers to get to market faster, even in the absence of special treatment from home countries.

Among practices that will continuously support these efforts include reliance practices especially between countries in the regional economic communities (RECs) and later within AMA framework.

It is exciting to take note of efforts towards establishment of continental framework for reliance thanks to efforts by AUDA NEPAD and partners.

The WHO GBT assessments and the race to Maturity Level 3 (ML 3) by multiple countries in Africa will certainly play an important role as it will allow countries to have regional or even bilateral agreements for mutual recognition, which is the apex of reliance and is seen as a great enabler for regional manufacturers to bring products to market.

For this to work however, other enablers such as fast tracking of free movement of good as expected via the African Continental Free Trade Area will be crucial.

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For long time, the excess fragmentation of the local production industry and with “me too” type of products has held back the region from growth, with introduction of harmonised regulatory standards via RECs and ultimately via AMA will mean that countries can now consolidate the available markets as will be occasioned by free movement of products.

However, this is far from being realised owing to multiple administrative requirements and national requirements. It is therefore crucial for the countries through their national regulatory agencies to identify these administrative pain points and address them progressively.

By extension, consolidation of the manufacturing efforts should aid efforts towards strategic pool procurement, another important strategic market development tactic required to support growth of medical products market in Africa and to make it attractive to more investment.

At this juncture it is important to note that local manufacturing is not only for companies currently domiciled in the continent, but there are also those overseas companies that aspire to relocate at least some of the production activities to the continent.

However, they are often held back by among other circumstances the limited predictability of operating environment in Africa, and the obscure market signals, case in point is the recent exodus of major companies from sub-Saharan Africa in recent times.

Even among the most determined ones, a proof of concept is important before full scale production relocation. Unfortunately, the current environment doesn’t anticipate the in-between of local and overseas production.

Herein lies an important opportunity that we should take, that of putting together a clear framework of manufacturers that wish to transition some of the products from global sites to local / regional hubs in Africa.

Often the lack of clarity on this process hinders the smooth transfer of production activities. In this regard, we would encourage regional/national authorities to consultatively develop practical guidance for industry to effect these transfers.

This framework for instance should recognise the phased introduction of localization initiatives and offer the full benefits of the same upfront such as fast-tracked registration timelines among others.

Manufacturing of medical products must in the end make economic sense. To join the race for local manufacturing, Africa needs to exercise caution not to join the bandwagon without assessing where it really has a competitive advantage/edge.

The cost for production for most of the essential products is way favorable, for example, from India and China, perhaps after decades of systematic investment in local production by these countries.

Policy makers in Africa should therefore be cognizant to this fact and realize that just producing pharmaceutical products locally is not the only solution, identifying what makes economic sense, supporting factors within the manufacturing ecosystem including key enablers such as power supply, road infrastructure, the health systems capacity, tax incentives, sustainable supply of inputs and raw materials are equally very important. The starting point should be from where the continent has a competitive edge.

Finally, there is need to accelerate efforts to market shaping factors: The need to have a clearly defined market, additionally the market shaping aspects such as, taxation policies, differential pricing among others. need to be attended, to make the market attractive.

It is important to highlight the importance of creating a favorable manufacturing ecosystem that supports would be manufacturers.

Such would include introduction of common and shared services like Clinical Research Organizations (CROs), packaging materials suppliers, pharmaceutical manufacturing waste management among others.

It is therefore important to highlight the importance of some of the initiatives that the governments are putting in place such as the special economic zones, innovation campuses and regional centers of excellence all meant to support the mainstream manufacturers get the auxiliary services they require closer home and hopefully at competitive prices.

In conclusion, local and regional manufacturing of medical products is long overdue for Africa. However, careful consideration is required to address some of the aspects highlighted above among others.

Finally, to remember that this is for the long haul and not necessarily likely to be all successful in the short term but with the right investments, intentions and sustained support from all stakeholders is certainly realizable target.

The writer is Pharmaceutical Industry Expert & Commentator