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MUST READ!!! GOVERNMENT POLICIES AND IMPACT ON PHARMACEUTICAL SERVICE DELIVERY – PHARM. AHMED YAKASAI, FPSN

Permit me to convey the depth of my gratitude to the organizers of this seminar for the invitation extended to the President of the Pharmaceutical Society of Nigeria

Our nation has always been privileged to enjoy a retinue of laws, policies, regulations, gazettes and related instruments structured to boost pharmaceutical services delivery in the ultimate public interest.

Stakeholders will have to remain circumspect and dispassionate if a critical appraisal of the various policies is embarked on.

For us to have an impactful insight this paper will take a cursory look at the National Drug Policy (NDP) 2005 which incidentally is the second edition of the NDP in Nigeria. This review will dovetail into government’s new tax policy which goes by the nomenclature Import Adjustment Tax (IAP).

 

  1. REVIEW OF THE NDP 2005

The maiden National Drug Policy (NDP) for Nigeria was adopted and launched in 1990 against the background of inadequacies in drug availability, supply and distribution resulting from various factors, such as:

 

  • An ineffective system of drug administration and control;
  • Inadequate funding of drug supply and drug ‘control activities;
  • High dependence on foreign sources for finished drug products, pharmaceutical raw materials, reagents and equipment;
  • Inadequate facilities for storage, transportation and distribution of drugs Poor selection and procurement practices;
  • The involvement of unqualified persons in procurement, distribution and sale of drugs;
  • Poor performance of drug suppliers to Public Healthcare institutions; and
  • Lack of political will to provide safe, efficacious and good quality drug to meet the health needs of Nigerians.

 

The policy was formulated with laudable goals and objectives intended to address the unsatisfactory situation at that time. Its adoption was seen as a positive development by observers. After over a decade of its adoption and implementation, a slightly below average progress has been recorded. These include the publication of an Essential Drugs List (EDL), and a National Drug Formulary (NDF), the establishment of a statutory agency with responsibility for drug administration and control (NAFDAC), and the introduction of drug registration procedures. However, much more still remains to be done in many areas, such as the realisation of self-sufficiency in local production of essential drugs, the establishment of an effective drug procurement system, evolving a well-ordered drug distribution system, the harmonisation and updating of drug legislation, the effective control of drug advertisement and promotion, the entrenchment of and commitment to rational use of drugs at all levels of health care, and drug research and development etc.

 

The goals of the NDP 2005 is to make available at all times to the Nigerian populace adequate supplies 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 essential drugs. In order to critically evaluate the attainment of the NDP 2005 with regards to pharmaceutical service delivery, it is important to highlight the targets of the NDP which includes:

  1. Establishment of a National Drug Policy Monitoring and Evaluation Division in the Food and Drugs Services Department of the Federal Ministry of Health by the year 2005;
  2. Total adherence to the use of the Essential Drugs List in public health institutions by 2008;
  • Production of National Standard Treatment Guidelines (STGs) for all levels of the health care system by 2006 and 80% adherence by 2008;
  1. 80% adherence to good drug procurement practices in the public sector by 2008;
  2. Entrenchment of a rational and properly structured drug distribution system in the private sector by 2008;
  3. 90% of targeted publication of prices of essential drugs by 2005;
  • Availability of adequate drug storage conditions in 80% of the public and private health care sectors by 2008;
  • Proper disposal of expired, deteriorated and sub-standard drugs in 60% of public and private care health facilities by 2008;
  1. Establishment of appropriate storage and quality control laboratories at designated ports of entry and export of drugs by 2005;
  2. Establishment of three new, fully equipped and adequately staffed laboratories in strategic locations of the country for more effective quality assurance of drugs and pharmaceutical products in Nigeria by 2005;
  3. Establishment in every public health care delivery institution at the federal, state, and local government levels by the end of 2005, properly operated drug revolving fund schemes with distinct bank accounts, transparent drug procurement procedures and mechanisms to check diversion of the fund for other purposes;
  • Total compliance with national guidelines on drug donations by 2008;
  • Increase in local production capacity to a level where 70% of total output satisfies at least 60% of national drug requirements of essential drugs while the balance is exported by 2008;
  • 80% awareness of the concept of rational use of drugs by prescribers, dispensers and consumers by 2006; and 60% adherence by prescribers and dispensers by 2008;
  1. Inclusion of the Rational Use of Drugs Concept and the National Drug Policy Issues in the curricula of all health professional schools and continuing education programmes by 2006;
  • 80% adherence to the rational use of narcotics and antimicrobials in the country by 2008;
  • Institutionalization of functional Drugs and Therapeutics Committees and drug information centres in 60%of secondary and tertiary health facilities by 2007
  • Publication of a list of all medicines in the Nigerian market in three categories, namely prescriptions only, pharmacy only, and general sale by 2005;
  • Awareness of appropriate self-medication practices by 40% of the population by 2008.
  1. Establishment, by 2006, of well-equipped national and zonal pharmacovigilance centres and achievement of 40% reporting of adverse drug reactions by 2008;
  • Total compliance of all drug promotion and information with national regulations by 2005;
  • Annual publication of registered drugs by 2004 and thereafter;
  • Provision of funds to satisfy a minimum of70% of research needs by 2006;
  • Publication of a Nigerian Pharmacopoeia, incorporating a list of effective herbal medicines by 2005;
  • Enactment of a reviewed and harmonised drug legislation in Nigeria by 2006;
  • Commencement of harmonisation of drug laws in the ECOWAS sub-region by 2006;
  • Full integration of the drug management aspects of all Ministry of-Health programmes by 2005; and
  • 60% compliance with the use of EVDL, VDF, SVTG in veterinary practice by 2008.

 

The NDP 2005 has been a mixed grill in terms of deliverables using the various goals, objectives and targets (which give us specific timelines) as a benchmark. A comprehensive analysis of the twenty eight (28) targets is graphically reflected below.

 

  1. It is noteworthy that a NDP monitoring and evaluation division now exists in the Food and Drug Services Department of the Federal Ministry of Health. This division tilts towards a proactive output and even coordinated botched attempts to develop a Drug Prescription Policy for the nation in 2013.
  2. Total adherence to use of the Essential Drug List (EDL) in public health institution by 2008 remains a mirage. Checks conducted on primary, secondary and tertiary health institutions in public sector confirm that adherence rate is abysmally low as it is less than 50%.

iii.        While the appropriate committees have produced the National Standard Treatment Guidelines (STGs) for all levels of the health system, it is certainly not an impactful document. The recently constituted National Essential Drugs and Formulary Committee having observed that care-providers would rather use reference books from other climes is canvassing more political will to entrench the recently launched EDL and STGs which were launched in July 2017.

  1. The drug procurement practices in the public sector remains a sour point especially at the level of the Federal Ministry of Health itself. For the records major drug procurements at Federal Ministry of Health are not coordinated by the Food and Drug Services Department. The fallout of this misnomer is to contend with hundreds of millions of expired drugs because of deficient drug quantification. The 80% adherence expected since 2008 will remain an unrealizable utopia for as long as government does not change its methodologies to embrace total professionalism.
  2. The structuring of the drug distribution system which should have been attainable in 2008 is still grounded in no remarkable departure from the status quo in 2017.
  3. The target of publication of prices of essential drugs is non-existent, yet a 90% adherence was set 12 years ago.

vii.       Appropriate and adequate drug storage in public and private health facilities need to be improved upon; while vaccines are often times kept well in cold chains same may not be applicable for other categories of drugs.

viii.      Disposal of expired and sub-standard drugs is officially handled by NAFDAC today. We have not however met the 60% adherence rate set for 2008.

  1. Establishment of quality control laboratories at our port of entries is still not the norm even at the officially designated airport and seaports for drug importation in Nigeria.
  2. Establishment of 3 new laboratories for quality assurance of drugs in strategic locations has been achieved.
  3. The DRF which should have been a panacea to resolve age long challenge of out of stock syndrome is in shambles in most Public Health Institutions from primary to tertiary level. The fundamental defect usually is decapitation of the funds through diversions to endeavours other than purchase of drugs as most hospital managements do not allow pharmacists who should be project managers of DRF to be signatories to the DRF accounts thus outrightly jeopardizing the system. In institutions like the National Orthopaedic Hospital, Igbobi the credibility of DRF is legendary. Today the Pharmacy Department has put up a property worth at least N150m from the proceeds of a well run DRF without compromising the integrity of the DRF.

xii.       Compliance with national guidelines on drug donations is largely haphazard.

xiii.      The tilt towards self sufficiency of essential medicine remains a tall order as over 70% of our drugs are still imported. Investment and funding of manufacturing endeavours remains far in between as incentives are lacking. The not too impressive credentials in local drug manufacturing at  a time we have successfully gotten four of our local manufacturers to receive WHO pre-qualification certification remains a big concern as the contribution of the pharmaceutical sector to National Domestic Products remains very insignificant.

xiv.       Rational drug use by prescribers, dispensers and consumers set for 2006 is a ruse. The unholy concept of dispensing doctors and prescribing pharmacists continues to flourish.

  1. Inclusion of rational drug use in the curricula of health professional schools is not a reality.

xvi.       Poor control of the use of narcotics and antimicrobials is still commonplace in 2017 despite our time line of 2008.

xvii.      A partial institutionalization of functional Drugs and Therapeutic Committees and Drug Information Centres (DIC) has taken place in some Federal Health Institutions (Tertiary). However, less than 20% of secondary facilities have DICs.

xviii.     Official bureaucracy and other efforts towards listing available medicines in Nigeria along the lines of OTC, pharmacy only and prescription only medicines have been perennially stalemated.

xix.       The philosophy of responsible self medication is not yet grasped by the majority of the population. Even the modest target of 40% by 2008 has not been achievable.

  1. Pharmacovigilance is gradually being entrenched and more of ADR reporting is being achieved in Health Institution.

xxi.       Compliance of all drug promotion and information with regulators is gradually coming up. The 2005 deadline was not met.

xxii.      NAFDAC regularly publishes list of registered drugs which is also available on its website.

xxiii.     We have failed woefully to dedicate funds for research and development in pharmaceutical sector like all other sectors of national life.

xxiv.     A Nigerian pharmacopeia incorporating herbal medicines not achievable since 2005 target.

xxv.      Harmonised drug legislation in Nigeria is still not attainable.

xxvi.     Harmonised drug legislation in the ECOWAS region is still not attainable.

xxvii.    Extremely poor integration of drug management aspects of Federal Ministry of Health endeavours like witnessed in NACA coordinated HIV/AIDs drug management that gave birth to ARV dispensing doctors.

xxviii.   Poor compliance with the use of EVDL, VDF, SVTG in veterinary practice thus jeopardizing the 2008 target.

 

From the in-depth appraisal in the review of the NDP 2005, it is very obvious that government and stakeholders in health failed woefully to meet the target of the NDP 2005. In apocalyptic terms, we have been able to achieve only a success rate of about 40% even as at 2017 for a 2005 implementation plan designed to achieve peak levels within a five year period.

 

  1. THE IMPORT ADJUSTMENT TAX AND DRUG PRICES

Prior to the new tax policy dubbed Import Adjustment Tax which now imposes a 20% tax on imported medicines, what existed was a 0% duty on imported duty.

 

Nigeria a major sub-regional super power had supported ECOWAS position that since there was a dearth of medicine manufacturers in the West African region; a need arose to meet the gap in supply through affordable imported drugs. The only realistic means to achieving this was reasoned to be charging zero or insignificant duties on medicines.

 

Even before the ECOWAS treaty the World Trade Organization (WTO) which Nigeria subscribes to in 1988 recommended not more than 5% duty on medicines because of its life saving nature. This was probably the motivation for Nigeria to adopt the ECOWAS position of 0% duty on medicines in 2013 as this was perceived as an incentive to affordable medicines in the Nigerian market. Today this has now been reviewed by a recent circular of the Federal Ministry of Finance with consequences for consumers of health.

At an exchange rate of close to N400 to a $1, importation of medicines is already bad business which an additional burden of 20% Import Adjustment Tax may sound a retrogressive knell.

 

The current National Drug Policy (NDP) 2005 has as its thrust a vision to make safe, efficacious and affordable medicines available to all Nigerians. This new 20% Import Adjustment Tax toughens the attempts to attain the NDP 2005. The other dimension is that once genuine medicines are not affordable, merchants of death who trigger the fake drug syndrome will return in full measure to do what they do best. If the medicine market is flooded with fake drugs, the other dimension of the NDP 2005 to have safe and efficacious drugs would have been compromised.

 

In Nigeria today the most obvious scenario of the graphic context is to look at malaria as a clinical disease state. We say that 65% of clinical visits are malaria based. Incidentally, the National Malaria Policy advocates the use of Arthemisine Combined Therapy (ACT) medicines as drugs of choice in the treatment of malaria.

.

The present increase has taken the average shelf price of an ACT medicine to N1,600 with a propensity to hit N2,000.00 before the end of the year. It is the same scenario with anti-infectives particularly antibiotics which are common drugs of choice in our health system. It is obvious that what this policy might cause is to increase mortality rate in the ranks of consumers of health if it is not carefully managed.

 

Statistically, malaria reportedly killed about 200,000 in 2015 alone when the average price of ACTs was less than N700.00, it is then left to imagine what the fatality rate will be like from 2017 at a price above N2,000.00 for a country that runs an obviously deficient and unsuccessful National health Insurance Scheme which still compels over a 70% out of pocket expenses for health.

 

The PSN will continue to canvass the dire need to attain self sufficiency in local drug manufacturing through setting realistic targets on a short, medium and long term basis.

 

It is imperative to insist that the Import Adjustment Tax of 20% must be applicable to those drug products our local industry has installed capacity and capacity utilization to produce on a short term projection.

 

THE WAY FORWARD/SUGGESTIONS

  1. Government must bring the necessary political will to bear on the system through advocacy, better funding and relationship management of professional bodies/NGOs in the quest to entrench the use of EDL and STGs in all public health institutions.
  2. The Federal Government owes Nigerians a sense of responsibility to redress the monumental injustice associated with drug procurement practices where the Food and Drugs Department is side-lined conveniently in the overall procurement implementation plan. In previous dispensations this led to enormous waste transcending into huge hundreds of millions of expired drug products. In the Federal Health Institutions, it took a presidential intervention in 2010 to compel hospital managements to allow the pharmacy departments handle drug procurement in line with existing statutes.
  3. The finest tenets of supply chain management including adequate and appropriate storage conditions must be embraced in the value chain of drug distribution at Public and Private Sector levels.

 

  1. In Public Health interest more equipped laboratories must be established in strategic centres in drug distribution and the officially designated airports and seaports for drug importation to boost an agenda of quality control and assurance of drugs offered for sale in Nigeria.

 

  1. Government must tinker with the obviously sabotaged DRF in public health institutions. The DRF has gone beyond a policy matter as it is encapsulated in the provisions of decree 43 of 1989 now EDL Act Cap 252 LFN 2004. In the reality, that it is a statute, it is compelling that Public Health institutions at primary, secondary and tertiary levels follow the dictates of its implementation as provided for in both the NDP 2005 and the EDL Act.

 

The PSN strongly advocates zero financing to resurrect the DRFs in our Public Health institutions. All it takes is to canvass seed stock from pharmaceutical manufacturers and importers to commence new schemes. To ensure competence and efficiency we strongly posit that interested public institutions will sign MOUs with the suppliers to assure them of payment after six weeks credit supply. The MOUs must also insist on adherence to form books especially the provisio that pharmacists will be signatories to all DRF account to avoid decapitation.

 

  1. The Federal Government must commence an agenda to boost local manufacturing of drugs. This would include granting tax holidays and incentives as well as compulsory patronage of the local pharmaceutical industry. For the local pharmaceutical industry to grow all products which can be sourced through installed and demonstrable capacity utilization should not be imported.

 

  1. The Federal Ministry of Health must complete work on the delineation of categories of available drugs in Nigeria on the basis of OTC, pharmacy only and prescription medicine. The stratification boosts professionalism as well as enhances the prestige of all major players in the pharmaceutical sector.

 

  1. The Federal Government should immediately review the 20% import duty on imported medicines along the reflected lines and categories:

 

–        Category A

Include all pharmaceutical products that are manufactured in the country, with PROVEN ADEQUATE local manufacturing capacity (following an independent forensic audit by an accredited auditor.

 

Recommendation: 20% Import Adjustment Tariff (IAT)

 

–        Category B

Include all pharmaceutical products that are manufactured in the country, but withINADEQUATE local manufacturing capacity.

 

The local manufacturers should engage the importers for possible contract manufacturing of ‘Own Brand Labels’ to attain the required local capacity by the country.

 

There should be a calibrated upward review of the import tariff following a bi-annual independent forensic audit/review by an accredited auditor/institution.

 

Recommendation: IMMEDIATE 5% IAT with upward bi-annual review up to 20% until 100% local manufacturing capacity is reached.

 

–        Category C

Include all pharmaceutical products that are NOT manufactured in the country, but CAN BElocally manufactured.

 

The local manufacturers should engage the importers for possible contract manufacturing of ‘Own Brand Labels’ to attain the required local capacity by the country.

 

There should be a calibrated upward review of the import tariff following a bi-annual independent forensic audit/review by an accredited auditor/institution.

 

Recommendation: 5% IAT in 2019 with upward bi-annual review up to 20% until 100% local manufacturing capacity is reached.

 

–        Category D

Include all pharmaceutical products that CANNOT be manufactured in the country either because the molecules are under patent or because we do not have the required technology locally.

 

Recommendation: 0% IAT until such product or molecule can be categorized under Category C.

 

  1. The Federal Ministry of Health must resuscitate work on the suspended National Prescription Policy which the NDP division of the Food and Drugs Department coordinated in 2013 at the behest of former Health Minister, Prof. Christian Chukwu. The practical way to enhance rational drug use is to ensure legitimate prescription and dispensing habit in the Health System.

 

  1. Government must compel public sector pharmacies in secondary and tertiary to run DICs, while hospital managements institutionalize Drugs and Therapeutic Committees.

 

  1. Creating the template for responsible self medication in the ranks of consumers through advocacy and counseling.

 

  1. Better appropriation of funds for research and development endeavours in the pharmaceutical sector through NIPRD and special research units in the universities like the Drug Research and Production Unit, OAU, Ife, Centre for Drug Discovery, Research and Production at University of Ibadan and others. We must also encourage partnerships between the private sector and the various faculties of pharmacy.

 

  1. A full integration of the drug management aspects of the special intervention programs of the Federal Ministry of Health including HIV/AIDs, tuberculosis and leprosy, guinea worm, onchocerciasis and other clinical disease state.

 

  1. Embracing the use of EVDL, VDF, SVTG in veterinary practice. The ground rules in the use and dispensing of veterinary drugs must also continue to be subjected to the dictates of the relevant Poison and Pharmacy Act.

 

The Federal Government must as a necessity give effect to all statutory appointments in the pharmaceutical sector including a substantive DG and Council of NAFDAC, Chairman and Council of PCN as well as Council of NIPRD.

 

  1. Government must enforce the deadline of the closure of Open Dug Markets, while making it very clear to owners of CWCs that they must deliver on their facilities. All would be operators must also participate in capacity building workshops to enhance professionalism in these facilities.

 

  1. Funding of the key regulatory agencies and research organizations including PCN, NAFDAC and NIPRD remains a major stimulus in the overall sanity of the pharmaceutical space as a prelude enhancing good service delivery in the sector.

 

CONCLUSION

The NDP 2005 has certainly not impacted on pharmaceutical services delivery, even though there is ample room for improvement especially in the current dispensation where the leadership of the Federal Ministry of Health appears focused.

I wish to thank the organizers of this seminar once again for inviting me to participate. I assure you as always that our doors are always open to dialogue and rules of engagement to advance the profession of pharmacy. May the Almighty God bless our nation and profession continually in His mercies.

Thank you very much.

Ahmed I. Yakasai,FPSN,FNAPharm,FNIM

President, PSN

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