healthcare

Realising Local Manufacturing of Vaccines

October 6, 2021

Stakeholders in the Nigerian pharmaceutical industry share their views on how to make the National Vaccines Policy sustainable, Dike Onwuamaeze, writes

Nigeria is set to reap from the unintended consequence of the outbreak of COVID-19 pandemic disease, which chartered global socio-economic lives in the whole of 2020 and still ravaging on.

Woken by the devastation the pandemic wrecked on its national life and its exposure of the weaknesses in the country’s health sector, the federal government launched the Nigeria Vaccine Policy (NVP) last week on Thursday, September 30. It is the first of its kind in Nigeria.

The policy was meant to encourage the manufacture of vaccines in Nigeria and enhance access to the use of vaccines for protection of its citizens from infectious diseases.

Speaking at the launch of the maiden edition of the NVP, the Minister of Health, Dr. Osagie Ehanire, declared that the policy would create a supportive environment for access and use of vaccines as well as setting the requirements and mandates for protection of citizens from internal and external harm.

Ehanire observed that there is need to resuscitate the local production of vaccines and intensify research and development along the same line.

The federal government, in furtherance of this objective, had a partnership with May and Baker Pharmaceutical, that established the Biovaccine Nigeria Limited (BNL) to encourage local vaccine manufacturing.

In addition, the unveiling of the NVP would enable prospective domestic manufacturers to use appropriate technologies in modern vaccines production to boost local production of vaccines in Nigeria and make vaccines available to Nigerians and the entire West Africa.

He said: “A NVP will reflect new realities and trends, including the provisions enumerated in the Universal Health Coverage (UHC), Sustainable Development Goals (SDGs), National Health Act 2014, National Health Policy 2016 and PHC Under One Roof (PHCUOR). This will further ensure the development of strategies that will respond adequately to global health trends for emerging diseases and pandemic that impact on the Nigerian health system.

“Most importantly, the ongoing global efforts to develop COVID-19 vaccines further provide a strong justification for enacting a NVP in the interest of achieving vaccine security in Nigeria,”
He asked the governing council of the BNL to mobilise resources from governments across all levels, individuals, the international communities, donor agencies.

Ehanire noted that the launch of the third edition of the national drug policy came on the heel overall Health Sector Reform (HSR) Programme (HSRP) of the federal government.

According to him, “no matter how vibrant a health policy, without availability of good quality and affordable medicines, that policy will be sterile.”

He said the government has also taken a number of pragmatic steps towards boosting the local capacity for the manufacture of essential medicines “to ensure that the local pharmaceutical industry becomes a major actor in providing good quality essential medicines for our health care programmes.

“It is my earnest hope that the launch of the third edition of the National Drug Policy will further increase the vibrancy of the pharmaceutical sector for the overall improvement of people’s health,” he said.
Earlier, the Permanent Secretary in the Federal Ministry of Health, Mahmuda Mamman, said a NVP was required to achieve an effective manufacture, storage, importation and distribution of safe, effective and good quality vaccines to the end users, adding that countries needed to have strong mechanisms that would enable informed decision-making about immunisation priorities and the introduction of new programme strategies, vaccines and technologies.

The declaration of the NVP resonated with the conversion a day earlier by the country’s eggheads in the pharmaceutical sub-sector under the theme “Enhancing Local Manufacturing of Medicine and Vaccines,” which was organised by the Nigeria Economic Summit Group (NESG) as part of its build-up to its NESG27 Conference titled “Securing Our Future: The Fierce Urgency of Now.”

According to the Minister of Industry, Trade and Investment, Mr. Niyi Adebayo, who was represented by an Investment and Agribusiness Advisor, Ms. Judy Melifonwu, at the NESG’s event, said that self-sufficiency in the local production in medicines and vaccines would undoubtedly go a long way in preserving lives of Nigerians.

Adebayo observed that the current COVID-19 pandemic has created a global vaccines production race that some countries and companies have taken advantage and made billions of dollars from the production of vaccines. It has also forced countries to examine how self-sufficient they are in the development of medicines by amplifying the vulnerabilities of the health sector.

He said that Nigeria should analyse where it stands and “what we need to do to take us where we need to be.

Nigeria as the largest market in Africa always has the potential to emerge a major pharmaceutical manufacturing hub in Africa. Yet, we are able to meet only 30 percent of our demand for pharmaceutical products through domestic production, which leaves a significant gap being met through importation.

The local pharmaceutical manufacturers are currently subdued by high cost of production, low uptake by consumers and the importation of low cost sub-standard syringes and needles.

Adebayo said: “The Ministry of Industry, Trade and Investment has worked extensively with the Ministry of Health and various industry players, key stakeholders to develop a national industrial policy on medical devices. This calls for high import duties on raw materials and machineries, high interest rate on credit and also the importation of sub-standard syringes and needles into the country. Our aim is to ensure Nigeria produces good quality, affordable and accessible medical devices and create jobs for skilled young Nigerians.

For the Founder and Managing Director of the Fidson Healthcare Plc, Dr. Fidelis Ayebae, there is no other path for sustainability than local manufacturing “because there will be times like this as we have now with the pandemic when every country will have to protect its own. I am not surprised with the so called vaccine nationalism and other therapeutic agents for the management of COVID-19. Every country is affected and impacted and the primary loyalty of any leader is to his people.”

He identified the absence of clear headed and targeted policy by the government to protect the pharmaceutical industry as the major issue hindering the expansion of access and availability of vaccines and drugs in Nigeria.

“Any country that cannot manufacture on a sustainable basis the drugs it consumes is in the process of being consumed in times of crisis and war. Nigeria unfortunately is facing this reality at the moment. We have not had clear headed and focused policies to address how to make drug manufacturing sustainable in Nigeria.”
The President of the Pharmaceutical Society of Nigeria (PSN), Mr. Sam Ohuabunwa, said that policy on health care provision from manufacturing to distribution should be matched by consistent action by avoiding policy inconsistency that move the country a step forward and two steps backward.

Ohuabunwa said that the COVID-19 shock has woken Nigeria to begin to take actions. “But it is an all emergency actions and soon we will go back to our ways.”

He said that the viability of manufacturing vaccines in the country would be affected by the limited customer base for the product as vaccines were not sold in the open market.

Ohuabunwa also warned that the government should avoid the policy summersault that ruined the country’s past attempt to manufacture HIV drugs in the country.

“We want to be sure that our governments are ready to buy our vaccines. Because we have had cases where we were told to make HIV products but government made its purchases from multilateral agencies. That frustrated those who invested money in the HIV products. I hope it won’t happen in vaccines down the road. There must be holistic policies that see the end from the beginning so that we can sequence what we can do at each stage. We need to speed up FX allocation and customs clearance,” he said.

The Chief Executive Officer of May and Baker Plc (M&B), Mr. Patrick Ajah, who was represented by Mr. Everest Okeakpu, said that a lot is happening in the vaccines manufacturing in the country through the establishment of the BNL, a joint venture between the federal government and the M&B.

Ajah said that his firm’s strategies to address the issue of local manufacture of vaccines in Nigeria were based on five cardinal pillars, which include infrastructure for capacity building for local manufacture of essential vaccines.

The second strategy is putting in place infrastructure for the manufacture of vaccines critical to the West African region. “Of course, when you are able to manufacture the traditional vaccines, the skills you learn from it will now be translated to begin to address those challenges that are peculiar to Nigeria. For instance, every year we have the Lassa fever outbreak and a couple of them that are vaccines preventable diseases. Because of the shortfall of the capacity to be able to do this locally we have not been able to address this challenge that is peculiarly ours. And no big foreign pharmaceutical will invest money there unless Nigerians,” he said.

The third strategy is to have institutions that would address the issue of vaccine hesitancy in the country. He argued that the effective way to address vaccines hesitancy is to have them manufactured locally.
The last of its strategy is training and capacity development for the people who will carry on this dream.
“There is need for collaboration among all stakeholders in identifying implementable actions, finance and timelines to competitively produce Nigerian vaccines.

“The critical success factors are basically technology partnerships that is needed to begin to manufacture vaccines locally.

“We need infrastructural requirements and enabling ecosystem. Policy thrust should support these efforts. It should address issue of market access and some incentive for technology transfer. There is need to look at the regulatory environment. The NAFDAC and customs should not feel that they are solely revenue making agencies of government.

“Also is funding and grants in the right currency, particularly at “these initial stages where you are required to procure equipment that are not manufactured locally.”

The Chief Executive Officer of the GlaxoSmithKline Plc (GSK), Mr. Kunle Oyelana, said that collaboration between local manufacturers and multinational pharmaceuticals is needed to make a success of the NVP in terms of building their capacity to produce quality exportable products.

“The priorities should be how we should formalise these partnerships and collaborations with the global players in order to bring global best practices into Nigeria for the local manufacturers. This has begun to happen. One of the things that are needed is a framework around the collaboration for in-country manufacturing. The pharmaceutical industry should be prioritised for foreign exchange because we are dealing with products that save life every day.

“I am also conscious that the AfCFTA is quite at the door. So, it is important that this collaboration should happen so that the pharmaceutical industry in Nigeria can take the advantage,” he said.

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