Overdependence on drug importation, others kill local pharma industry, threaten medicine security

With Nigeria’s growing population expected to hit 206 million by 2020, ensuring national sufficiency and medicine security is crucial in tackling diseases, mortality and catering for other healthcare needs.

It is also important in combating falsified, substandard and counterfeit pharmaceutical products, which pose threat to the economy and security of the nation.

But unfortunately, Nigeria’s overdependence on drug importation and donor aid, not only put the lives of Nigerians at risk of these falsified, counterfeit and substandard pharmaceutical products, which sometimes leads to death due to its adverse effect in the body, but also threatens the attainment of the United Nations’ Sustainable Development Goals (SDGs), 1, 3, 8 and 9, which seeks an end to extreme poverty, ensure healthy living, promote sustained, inclusive economic growth and productivity, as well as sustainable industrialisation.

The local pharmaceutical manufacturing industries have also cried foul on the situation of medicine production in the country, blaming the Federal Government of frustrating efforts of local drug production and the sector, by putting stringent barriers to paralyse the industry worth about N300 billion, while foreign drugs and companies are patronised.

Also, players in the pharmaceutical industry decry a situation where 70 per cent of drugs consumed in the country are imported, which is against the National Drug Policy 2005 as amended that stipulates that, among other things, 70 per cent of the drugs consumed in the country should be produced locally while 30 per cent is imported.

Meanwhile, Nigeria and other African countries spend at least $14 billion on importation of pharmaceutical products needed in the continent, owing to lack of capacity in local products, according to the United Nation’s Economic Commission for Africa’s (ECA) Executive Secretary, Vera Songwe.

Key players lament
The Chairman, Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG-MAN), Dr. Fidelis Ayebae, stressed that it is worrisome to note that Nigeria, which is known as the giant of Africa with its vast natural resources, is overly dependent on imported drugs and donor aid to satisfy the essential medicine needs of her rapidly growing population.

Ayebae, who is also the Managing Director/Chief Executive Officer, Fidson Healthcare Plc lamented that the local facilities have remained under-utilised, while the government is paying no attention to the pharmaceutical sector.

He stressed that it is very discouraging to see the products, which the industry has the capacity and competence to produce locally are being imported into the Nigerian market space.

He said each time the government imports medicines from other countries; Nigeria takes a step backward and limits her attainment of the Sustainable Development Goals.

“With about 200 million people, Nigeria cannot depend on importation of drugs, unless its population suffers from various health hazards.

“We need to prioritise local pharmaceutical industry. We are making Nigeria a dumping ground for the rest of African countries who are positioning themselves with the opportunity provided by African free trade,” he noted.

The Chief Executive Officer, Miraflash Nigeria Limited, Oluwalade Moses, said pharmaceuticals cannot be taken away from the system, noting that the rot in the system is as a result of “government’s greed for money and the inordinate ambition of political office holders.”

He stressed that the environment for local pharmaceutical industry to thrive and produce medicines for her population is not made available, thereby limiting the industry and the country from attaining medicine security and national sufficiency.
Limitations to medicine security

Minister of State for Health, Dr. Adeleke Mamora

The Minster of State for Health, Dr. Adeleke Mamora, said, while the United Nations’ report projected Nigeria to be the third most populous country by the year 2050, it has therefore become imperative to adopt the concept of medicine security and national sufficiency.

He said there are numerous challenges faced by the pharmaceutical industry, among which are access to finance to set up appropriate infrastructure and good pharmaceutical quality management system, in line with the World Health Organisation (WHO) pre-qualification standard and benchmark.

Mamora said other limitations facing the industry include, none capacity utilisation and patronage by state actors; challenges of market access and policies that are not so protective of the industry, as well as harsh business environment, lack of access to raw material, poor research and development culture.

The Minister said: “Oftentimes, some of our hospitals run out of stock for drugs, that is, medicines not been available. We need to look at what is available to us and make the best of it and in doing this; we cannot allow other countries to turn Nigeria into dumping ground.

On his part, the Director, Chemical and Non-Petrochemical, Industrial Development Department of the Federal Ministry of Industry, Trade and Investment, Dr. Francis Alaneme, lamented that the challenges and deficiencies affecting medicine security, affordability and self- sufficiency in Nigeria include: fake and counterfeit products; lack of patronage to locally manufactured medicines; and issues in the upgrade of pharma factories to achieve WHO pre-qualification.

Others are: difficulties in the overdependence of imported raw materials; weak technology and engineering base; weak industrial linkages and supply chain (chaotic distribution system); weak regulatory environment; poor funding and lack of access of credit; and multiple taxations and levies.

Also lamenting on the limitations to national medicine security, the Managing Director of Ferma Pharmaceutical Industries, Prince Degun Agboade, noted that factors such as, the absence of conducive environment for manufacturing, lack of infrastructure, high taxation, high cost of operating industry, among others, were limiting the local production of drugs, as well as expose the country to the dangers of falsified and sub-standard pharmaceutical products.

“There are so many problems. The first thing is funding, government selected some key areas and gave them special fund. Second is infrastructure, a lot of us having about two to four generators that we run with heavy cost on diesel. We don’t have infrastructure to put that together apart from electricity – we are the ones that build the roads to our factory – you have to dig the well for water and we refine it.

“Thirdly is patronage. Why should government take gifts for us, instead of asking us to manufacture. By the time they are giving us free medicines and they are saying they are through donors, we are exporting our employment to other countries. Let us produce here, we will employ lots of Nigerians,” he stressed.
Weak policy and regulations

The local pharmaceutical sector players lamented that since the National Drug Policy of 2005 was put in place to achieve medicine security, the country is yet to see the implementation of the policy.

Ayebae said while the sector thought of the drug policy to be the strongest illustration of government to achieve an enabling health professional drug policy for Nigeria, it has not implemented up to four per cent of the entire policy till date.

Bemoaning the government’s effort at enforcing its Import Prohibition List to checkmate influx of unsafe medicines into the country, Ayebae said: “As we speak, the closest competitor nation for us has 49 items on their import prohibition list, Ethiopia has up to 80, while Nigeria has only 11. The country that has 49 does not even have up to 50 percent of the total population of Nigeria.”

On the recent African Free Continental Area Agreement (AfCTA) signed by Nigeria along with some other African countries, Ayebae said government must do more to position the pharma industry, such that Nigeria does not end up as dumping ground for pharmaceutical products, which could endanger the life of the populace.

The Director-General, National Agency for Food and Drug Administration and Control, (NAFDAC), Prof. Christianah Adeyeye, stressed that weak regulatory system impedes strong pharmaceutical industry, noting that Nigeria’s lack of readiness will hinder its attainment of national drug security.

“It is time we got ready as a country, it does not matter how much we talk, without a strong regulatory system we cannot boast of quality drugs. To have a strong regulatory system is to build internal capacity and capability.

Director General, NAFDAC, Prof. Mojisola Christianah Adeyeye

“The role of NAFDAC is to enhance and strengthen the local manufacturers so that the million people that died because of Human Immuno-deficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) in Africa will not repeat itself. If we are not ready as a nation to take on the responsibility of providing ourselves with drugs, then the consequences will be grave.

“Of course you cannot manufacture everything in Nigeria, but we want to change the tide of imported to local. Our goal is to strengthen local pharmaceutical manufacturers so that we can have drug security at the peak of HIV/AIDS. This cannot succeed unless the NAFDAC is strong.

“We started with quality management system, a system where corruption doesn’t take place, rather you think of the harm of whatever wrong you will do to the patient, which may compromise the image of Nigeria,” she added.

Economic implications
Ayebae stressed that the ripple effect of over-dependence on imported medicine cannot be overemphasised.

He said the implications include, exporting jobs to other countries and importing poverty to Nigeria, exerting pressure on the country’s foreign reserve, as well as giving window for falsified, substandard and counterfeit medicine.

“The question arises that why is Africa poor and why is Nigeria poor? The reason why we are poor is because there are no enough economic policies for people to create wealth.

“One of the reasons why we are not getting enough economic opportunities is because of the policies we create and execute, that is why our youths are leaving the country in drones. How are we then creating economic opportunities?

“If we are to attain self-sufficiency and medicine security, deliberate radical policy must be put in place. An enabling business environment must be created by government to promote, protect and grow this industry,” he noted.

Agboade decried the weak policing of Nigeria’s boundaries to guard against importation of fake and sub-standard drugs, noting that the large amount of drugs seized by the customs at the ports, not only exposes the dangerous business of traffickers, but is also jeopardising the health of Nigerians.

He said out of five pharmaceutical companies that were qualified by international organisation to manufacture and sell drugs, three of the companies have liquidated as at today, because of the non-favourable and harsh economic environment, while some were sold off.

Meanwhile, Alaneme explained that the pharmaceutical sector is one of the five high priority manufacturing subsectors that has a high potential for development in the short to medium term for the implementation of Nigeria Industrial Revolution Plan (NIRP), which is now a component of Economic Recovery and Growth Plan (ERGP).

He said from studies and analysis, 15 percent to 25 percent of all healthcare spending in developed countries goes towards pharmaceuticals, while Nigeria allocated less than 20 per cent in its 2018 National budget.

This, he said, is significantly less than the USD 2 percent per capita, which is relatively low by global standards and the government is making efforts to bridge the gap.

“It has become necessary to ensure all machines for pharmaceutical production are zero duty. This is aimed at supporting local pharma industries to grow and ensure competitiveness. The sector had come a long way despite numerous challenges, but it has contributed to national building through paying taxes, tariffs and employs over 300, 000 person in direct and indirect jobs,” he added.

Lessons from India
The High Commissioner of India, Shri Abhay Thaku, said the key to India’s success has been affordable solutions, be it in machinery, housing, health, education, agriculture or telecom, while it is set to become the world’s fifth largest manufacturing economy by the end of 2020.

He said India’s Gross Domestic Product (GDP) is targeted to double from $2.5 trillion in seven years, adding that the country’s rapid growth will be accompanied by a stronger manufacturing sector, going up to 25 per cent of its economic output, while integrating even more into the global value chain.

Thaku said India leverages on bilateral economic cooperation and trade, with pharmaceuticals among its leading exports to Nigeria, with over 135 Indian companies operating in Nigeria and many more exploring to set up.

He said Indian-origin companies have invested over USD 10 billion in Nigeria’s pharmaceuticals and other sectors and are the second largest employers in the country.

“India companies are encouraged to examine opportunities and advantages as well as consider setting up their units in Nigeria to increase their localisation content, which would be the best way to sustain and promote economic and commercial growth,” he added.

Call for action
Ayebae said, while other countries consider self-sufficiency as an issue of national and political discourse, engaging robust policies, it will be strategic of the Nigerian Government’s next level led by president Muhammadu Buhari, to take full advantage of the Trade and Related Aspects of International Property Rights (TRIPS) flexibilities, by setting up a Committee on National Medicine Security (CONMS) to rig and re-invigorate the industry with radical policies that will ensure the following: establishment of local Pharmaceutical Manufacturers’ Expansion and Export Intervention Fund of N300 billion; ensure increased patronage of locally manufactured medicine by the government – enforce the Executive Order 003 faithfully with institutionalised monitoring and evaluation mechanism; expansion, enforcement and enhancement of the Import Prohibition List (IPL); sustenance of the Domestic Preference Policy as recommended in Public Procurement Act of 2007; zero per cent tariff for pharmaceutical raw and packaging materials as well as retention of 20 per cent tariff on imported finished pharmaceutical products that local pharma industries have capacity to produce.

Other recommendations, he noted are to: increase funding of NAFDAC to live up to the International Stringent Regulatory benchmarked standard, essentially supporting the NAFDAC 5+5 validity policy and following through and faithfully on the Federal Government of Nigeria plan on Expedited Medicine Access Programme (E-MAP).

Alaneme said the ministry is working with relevant stakeholders to ensure a holistic and robust National Industrial Policy for Pharmaceuticals, which will soon be ready for validation and onward submission to Federal Executive Council (FEC).

He said the policy will: ensure capability of local manufacturers to produce high quality, affordable pharmaceutical products across all essential medicines; reposition, foster growth and development of pharma industries in Nigeria through various incentives, concession and waiver; and ensure local production of at least 80 percent of the nation’s drug needs by 2022 through support programmes.

Others include: ensuring local manufacturing of vaccines in Nigeria healthcare and ensuring implementation of the Executive Order 003 among Ministries Departments and Agencies (MDAs); and to ensure the sector is a net exporter of pharma products to Economic Community of West African States (ECOWAS)/ the African Continental Free Trade Agreement (AfCFTA) countries and beyond in the next three years.

This, Alaneme said, is to ensure Nigeria takes its rightful position in the continent, as well as improving the competitiveness of local manufacturers globally, improve Good Manufacturing Practice (GMP) and achieve WHO GMP certification for pharmaceutical companies.

He also recommended sanitising the distribution systems to international standards in order to eradicate fake and counterfeit products by adopting track and trace system; and supporting the development of the Active Pharmaceutical Ingredient (API)/fine chemical industry.

The chemical industry can be simplified into two main parts – fine chemicals, which are pure and complex, and bulk chemicals, which are made in huge quantities. Fine chemicals provide the means for things like drugs, fragrances, and additives in food. Some examples of bulk chemicals are ammonia, sulphuric acid, and sodium hydroxide, which are all made at large chemical plants via a variety of different processes.

Alaneme said this industry is expected to process pharmaceutical chemicals into synthetic medicinal substance, including the output of several intermediate substances.”
Way forward

Mamora said: “We need to work together in unity of purpose. Part of the bane of the health sector is inter and intra professional rivalry within the health sectors, it outweighs us and we need to down play that. The key enablers for good relationship are the five Cs, Cooperation, Collaboration, Coordination, Consultation and Cordiality. These one take place in the atmosphere of mutual respect and understanding.”

He added: “President Muhammad Buhari, earlier in the year, rolled out the Basic Healthcare Provision Fund, which was appropriated by the National Assembly in the 2018 budget.

“ The Basic Healthcare Provision Fund (BHCPF) is one percent of Federal Government consolidated revenue set aside to fund basic healthcare needs of Nigerians. There is need for strategic collaboration among stakeholders in achieving these laudable objectives.

“PMG-MAN does have a critical role to play in the area of supply chain management of the BHCPF in the delivery of medicines to primary healthcare centres.”

Mamora noted that in order to drive medicine security and attain national sufficiency, Nigeria must start focusing on home grown solutions, adding that the Federal Ministry of Health recently created a department of traditional medicine and alternative medicine, to have home grown solutions and to access medicines that are of high standards.

“We are not reinventing the wheel, but there must be standardisation with empirical data to back up any claim in herbal and alternative medicines,” he added.

Ayebae said: “We propose that government should as a matter of urgency prioritise the local pharmaceutical industry. Prioritising the industry from the perspective of medicine security and national sufficiency is the only guarantee to make the best out of the AfCTA protocols, which will make Nigeria the Continental Pharma Manufacturing hub. It will also prepare Nigeria to take advantage of the TRIPS Flexibility window of World Trade Organisation (WTO) when domesticated.”

Agboade urged the Federal Government through the Central Bank of Nigeria, to set up the N300 billion Pharmaceutical Expansion and Export Fund, which will provide soft loans to upgrade and improve the factories, as well as increase capacity among indigenous drug manufacturing companies.