… Seek Urgent Reforms In Drug Regulatory Agenciesand

LAGOS – Stakeholders have urged the Health Ministry to urgently implement comprehensive reforms in drug regulatory agencies, repeal high tariffs for drug products, and GMP inspections with NAFDAC for Nigeria to fully benefit from President Bola Ahmed Tinubu’s recent Executive Order.

On Friday, Independent Newspa­pers reported that President Bola Ahmed Tinubu signed an Executive Order to boost local production of healthcare products and reduce costs.

The targeted healthcare products include pharmaceuticals, diagnos­tics, devices such as needles and syringes, biologicals, and medical textiles.

The new order, according to Prof Alli Pate, Coordinating Minister of Health has introduced zero tariffs, excise duties, and VAT on specified machinery, equipment, and raw materials.

The Minister who hinted about the executive order in February, noted in a post on X Friday night that the new effort would reduce production costs and enhance local manufacturers’ competitiveness.

However, anxious Nigerians who have been grappling with the esca­lating costs of medications nation­wide are highly expectant that the new Presidential drug order would automatically bring down the prices of drugs which have hit the roof.

Contrary to this, stakeholders have alerted the Federal Govern­ment that the country may not reap the benefits of the newly approved Presidential Executive Order unless Prof Pate, quickly embarks on other complementary measures to bring down the skyrocketing prices of drugs in Nigeria.

The Pharmaceutical Society of Nigeria the number said one mea­sure is for the Minister to abolish tariffs of varying dimensions and other procedures and processes being contemplated by the prime regulators in the pharmaceutical value chain.

In a statement this weekend, Prof. Cyril Osifoh, the PSN President was among the stakeholders who made this revelation, despite hailing the Presidential Order. He urged for swift direct comprehensive reforms in drug regulatory agencies and the repeal of high tariffs and cost of reg­istration of drug products and Good Manufacturing Practice (GMP) in­spection with NAFDAC for Nigeria for Executive Order to succeed.

Usifoh’s statement reads, “We are particularly grateful that this order introduces zero tariffs, excise duties, and VAT-specified machin­ery, equipment, and raw materials aimed at reducing production cost and enhancing our local manu­facturers’ competitiveness. This demonstrates that the Nigeria Health Sector Renewal Investment Initiative (NHSRII) is not just anoth­er government initiative but a genu­ine commitment to turn around our ailing health sector.

“The potential for success in this Order is boosted because specified items include active pharmaceuti­cal ingredients, excipients, essential raw materials required for manu­facturing of crucial heat products including drug long-lasting insecti­cidal bed nets, rapid diagnostic kits, and others.

“The Pharmaceutical Society of Nigeria is excited about the pros­pects of this order and therefore encourages the Coordinating Min­ister of Health to embark on other complementary measures instantly to bring down the skyrocketing pric­es of drugs in Nigeria.

“One of such measures remains a tinkering with tariffs of varying dimensions and other procedures and processes being contemplated by the prime regulators in the phar­maceutical value chain.

“Furtherance to the above, the FMOH as part of its broad-spectrum oversight responsibilities must en­sure comprehensive reforms in regulatory agencies which have lawful approbation that borders on drug use and control. The FMOH should additionally evaluate the reality of things since it may take a lead time of 15 to 18 months to set up new manufacturing plants if all the capital is available.

“We certainly need improved installed capacity and capacity uti­lization in the pharma industry to attain the 70 percent target of local manufacturing of essential drugs in our country.

Consumers of health natural­ly imagine that with an executive order, drug prices that have soared will come down automatically by a significant quantum. The FMOH must assist the regulatory agen­cies in the pharma industry to have access to subsidy gaps which will automatically pave the way for a review of existing tariffs which stakeholders in our industry are forced to comply with.

“After the audacious act of sign­ing an Executive Order to create a heritage which we shall consolidate and preserve, the PSN and its lead­ership will work towards institut­ing a landmark in intensive care management with holistic local content,” the PSN boss added.

Recall that in February, Indepen­dent Newspapers reported that the Lagos State PSN Branch lamented the high costs of drugs in the coun­try. The Lagos PSN attributed the major cause of the high drug costs to excessive tariffs introduced in the last few years in the pharma sector as the burden is passed to consumers.

The Lagos PSN had called for urgent intervention by the Federal Government to curb the high cost of registration of drug products and Good Manufacturing Practice (GMP) inspection with the NAF­DAC.

Lagos PSN Chairman, Pharm. Babayemi Oyekunle stressed the need for the government to grant more tax holidays as well as remove some high tariffs introduced in the last few years in the pharma sector as the costs are passed to consum­ers.

The new Presidential Order on drugs should serve as a relief to Ni­gerians. Therefore, as many Nigeri­ans, especially stakeholders from the health, economic, and develop­ment sectors and beyond continue to express their reactions over the President’s action, Prof Mojisola Adeyeye, NAFDAC’s DG also at the weekend hailed the Presidential Order. Adeyeye said that it is a sig­nificant step towards transforming Nigeria’s health sector, promoting excellence and competitiveness among local manufacturers.

The DG in her statement said, “The perennial and persistent cost­ly challenge of importation of all materials needed for manufactur­ing (except water) by local manu­facturers became an open sore. As Director General, my professional heart ached for local manufacturers considering the import duties they have to pay for all materials, some packaging materials and equip­ment,” Adeyeye said.

According to the DG, since taking office, she has pushed for zero tar­iffs on medical supplies, including a short grace period to allow domestic manufacturers to catch their breath and focus on their core strength – producing high-quality medical products. “Then came the Tinubu Administration, and then the ad­ministration of the cerebral Coor­dinating Minister of Health and Social Welfare, Prof Mohammed Ali Pate, and Coordinating Minister of State for Health and Social Welfare, Dr. Tunji Alausa, who put the inter­est of the 200 million plus Nigerians before their interest. Then the un­imaginable started happening—giv­ing local manufacturers a chance to excel and be competitive.”

However, Pharm Olumide Akin­tayo, former PSN President, while lauding the new Executive Order approval, also frowned at tariffs and unfriendly policies by some of the key regulators in the pharma­ceutical sector. Akintayo reasoned that the presidential order would not lead to a reduction drug in pric­es amid such high costs of tariffs, registration of drug products, and GMP inspection with the NAF­DAC. Berating the development, Akintayo, stressed the need for the FMOH intervention to remove the tariffs and retrogressive policies which lead to the high cost of drug production.

He said, “The signing of an Ex­ecutive Order on the availability of Pharmaceuticals in Nigeria is a most significant development that patriots in our sector welcome wholeheartedly.

“We salute the sagacity of the Coordinating Minister of Health and the Permanent Secretary of the FMOH who have galvanized a com­mendable output in the Health Sec­tor in recent times. Prof Alli Pate is beginning to distinguish himself as one who means what he says and therefore does what he says.

“The inherent parturition this Executive Order brings must trigger off a new pharmaceutical industry couched and laden with possibilities and fruitfulness. “We must move away from perambu­lations in the wilderness of retro­gression.

“The Federal Government through the FMOH must progres­sively intervene in the matter of unfortunate tariffs and unfriendly policies churned out by some of the key regulators in the pharma­ceutical sector if prices of drugs will crash in the interim. This is because these tariffs are a major rea­son drugs availability, accessibility, and affordability can no longer be guaranteed in alignment with the National Drug Policy,” Akintayo maintained.

He made a case for the appoint­ment of an Adviser, Pharmaceuti­cals to the President who will coordi­nate the plethora of endeavors that are Pharmacy based and inclined in the Tinubu administration.