Besides guaranteeing the quality, safety and efficacy of medicines at affordable rates, experts say local production of essential drugs will create employment and boost economic development, reports Associate Editor ADEKUNLE YUSUF
To the detriment of her economy, Nigeria depends on importation to feed most of her essential medicine requirements. Annually, as all available records have revealed, between 70 to 80 per cent of Nigeria’s critical medicine needs are produced and supplied through pharmaceutical firms operating outside the country’s shores. That means about 80 per cent of employment opportunities that should have accrued to the country’s expanding army of unemployed graduates from the all-important industry are shipped abroad every year.
But that is not all. Besides turning Nigeria to a dumping ground for all manners of pharmaceutical products in a clime endowed with more than 150 drug manufacturing firms, importation has also ruefully gifted the country with problems of fake and counterfeit drugs. This is, however, not new. The threat of drug insecurity in Nigeria dates back to the 60s, though it was in the 80s and 90s that the crisis reached a climax when ‘briefcase importers’ of drugs created overwhelming situations of chaotic supply and distribution of drugs of questionable quality, with the attendant effects of increased morbidity, treatment failures, drug resistance and deaths. This led to the birth of NAFDAC to address the menace.
What drug security means
Last year, at the annual national conference of the Association of Industrial Pharmacists, in Ilorin, Kwara State, NAFDAC Director-General Prof. Moji Adeyeye delivered a keynote address on the imperatives of national drug security. At the conference, she defined drug security as “measures put in place to ensure that quality, safe and efficacious medicines are produced by facilities that meet the right standards and, that the integrity of such medicines is not compromised during its distribution along the supply chain from the manufacturers down to the consumers.”
Through a deliberate radical policy and an enabling business environment to promote, protect and grow the pharmaceutical industry, Nigeria should emulate other economic powers to attain national self-sufficiency in essential drugs production and ensure medicine security, she said. The imperatives of national drug security are enshrined in the national drug policy, which is to make available at all times to the Nigerian populace adequate supply of drugs that are effective, affordable, safe and of good quality; to ensure the rational use of such drugs and to stimulate increased local production of such drugs. This is also in line with the Sustainable Development Goal (SDG number 3), which seeks good health and wellbeing by targeting universal health coverage (UHC), access to quality healthcare services and safe, effective, quality and affordable medicines and vaccines for all.
The heart of the matter
The reality of drug insecurity in Nigeria can be dire. According to a report by the Federal Ministry of Health, some essential drugs, for example, drugs for diabetes or cancer are only accessible at prohibitive costs, sometimes, several times more than the minimum monthly wage of an average worker. In a country that runs largely an out-of-pocket payment system, this is usually exacerbated if the diabetes or cancer patients are unlucky to be at the low-income level, where about 62 per cent of Nigerian workers belong. Annually, for people living with HIV/AIDS, access to drugs has posed a threat of insecurity, as only about 30 per cent of adults and only 20 per cent of children are said to have access to ARV drugs among the people living with HIV in the country.
Another issue that is contributing greatly to drug insecurity is the menace of substandard and falsified medicines, foisting serious consequences on the populace. Among other grave public health implications, substandard and falsified medical products are responsible for treatment failure, high treatment cost, and development of resistance that are now prevalent in the healthcare delivery system. In many instances, outcomes include fatality and death, and the ultimate loss of confidence in the healthcare providers and healthcare system. This threat of substandard and falsified medicines is more predominant in the private sector, as NAFDAC officials regularly encounter unregulated, substandard and falsified medicines from unscrupulous importers who exploit the loopholes in the country’s drug distribution chain.
The huge dependence on importation, which has negatively impacted local production, is attributable to lack of basic research and development, including insufficient capacity in pharmaceutical analysis and bio-analytical techniques in the academia and the industry, inadequate training in current good manufacturing practices (cGMPs) and non-existence of API or excipients manufacturing facilities.
Prof. Adeyeye, however, believes this heavy reliance on imported pharmaceutical products is not an insurmountable challenge, stressing that it can be turned into an opportunity for the country. “This can be done through early phase collaboration of local manufacturers with foreign contract research organisations. Manufacturing of API and excipients should be encouraged through joint partnership of foreign/local investors. Proactive involvement of the academia in collaboration with the pharmaceutical industry is needed for translatable research that could result in development of bulk drugs and excipients and, subsequently, ensure drug security. However, the local industry has to be strengthened through government intervention and deliberate financing to reduce importation and establish pharmaceutical R&D,” she said.
Many manufacturers, low output
Despite the much-vaunted readiness of the Federal Government to diversify the economy, experts lampoon the poor official support for local manufacturing of pharmaceuticals, saying it is too meagre to improve the lot of the industry. Experts lament that it is sad and unacceptable that imported pharmaceutical products enjoy a zero duty tariff while manufacturing inputs attract heavy import duty tariffs. Currently, in Nigeria, importation accounts for more than 70 per cent of prescription medicine needs, leaving local manufacturers with only less than 30 per cent, sourced from about 150 registered local manufacturers, which are mostly small or medium scale.
This explains why pharmacists and other professionals in the health sector have recommended that Nigeria should devise strategies towards increasing local production of essential medicines to boost drug security, as it is done in other countries. Even on the African Continent, experts say Nigeria will not be alone if it enacts some protectionist measures to save the soul of its local pharmaceutical industry. Other African countries that have realised the strategic importance of the sector and are doing everything to grow their pharmaceutical industry for the benefit of their people are Ethiopia, Ghana, Morocco and other North African countries. Apart from refusing to allow their countries to become dumping grounds for pharmaceutical products from abroad, many African countries also have an unwritten rule that excludes all products being produced locally from their importation lists. For example, Ghana has no fewer than 49 pharmaceutical products on import prohibition list, believing that doing so will help to fast-track the development of its own local manufacturing firms.
When he assumed office as President of Pharmaceutical Society of Nigeria (PSN) earlier in the year, Mazi Sam Ohuabunwa dissected the problems afflicting the sector. Over the years, when the local manufacturing sector is not being punished with policy reversals, it will be a victim of official corruption, policy inconsistencies and multiple taxations, he said. “Import duties favour drug importers instead of producers. Government preaches what it does not practise. They must patronise made in Nigeria drugs and use them. Besides policy inconsistency, there are also problems of poor infrastructure, lack of patronage for local products and uncontrolled market space. We are still importing Active Pharmaceutical Ingredients (API) like grain starch, colourant, and additives and so on. These are things we have capacity to produce,” Ohuabunwa said.
But things may fare better soon. At the Fifth Nigeria Pharm Manufacturers Expo 2019, which held in Lagos recently, Dr. Olorunimbe Mamora, minister of state for Health, vowed that the Federal Government would not allow other countries to turn Nigeria into a dumping ground for foreign drugs, stressing that the administration is committed to home-grown drugs.
The expo was organised by the Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria. The new minister said the government believes in the capacity of her regulatory agencies to prevent dumping of foreign drugs in Nigeria.
“We are not just talking about drugs sufficiency, we are talking about homegrown; that is looking at what we have on the ground to get the best out of the system and this is very important. Oftentimes, in some of our hospitals, you hear out of stock. We need to look at what is available to us and make the best out of it. We cannot allow other countries to turn Nigeria into a dumping ground for these drugs. Let us make use of what we have; let us also reach out, even to the herbal practitioners. All we want to be sure of is to establish the efficacy and the safety of the drugs available,” Mamora said.
The way forward
Among pharmaceutical experts, there is a consensus that the Federal Government should target pharmaceutical manufacturing to achieve drug security. To do this, there should be radical policies focusing on expansion of pharmaceutical manufacturing firms, which the proposed N300 billion intervention fund is meant to achieve in the sector. If approved, the expansion fund will ensure that manufacturing firms will have enough funds to improve their facilities to meet the World Health Organisation’s (WHO) prequalification and standard. Besides the proposed intervention fund, there should also be increased patronage by government and zero per cent tariff for pharmaceutical raw and packaging materials, among other incentives.
