How Strengthening Medicine Regulatory

Authorities can Increase Access to Medicines

Dr. David MabiriziPrincipal Technical Advisor – HIV/AIDS

March 7, 2014

Systems for Improved Access to Pharmaceuticals and Services (SIAPS) ProgramImproved Access. Improved Services. Better Health Outcomes.

• USAID funded 5 year project

• Award: $197 million• Sept 2011- Sept 2016

Health Outcomes

Services

Products

SIAPS Goal and Objective

• Goal• To assure the availability of quality pharmaceutical

products and effective pharmaceutical services to achieve desired health outcomes

• Objective• To promote and use a systems-strengthening

approach consistent with the Global Health Initiative that will result in positive and sustainable health impact

Intermediate Results

• Strengthen pharmaceutical sector governance

• Build individual, organizational, and institutional capacity for pharmaceutical supply management and services

• Address the information for decision-making challenges in the pharmaceutical sector

• Strengthen financing strategies and mechanisms to improve access to medicines

• Improve pharmaceutical services to achieve desired health outcomes

Where SIAPS/SPS Works

• TA in 30 countries• Offices in ~22 countries• 340+ staff worldwide• 80+% of staff from host country

SIAPS 2011-13• Angola• Bangladesh• Brazil• Burundi• Cameroon• Dominican Republic• DRC• Ethiopia• Haiti• Jordan• Lesotho• Liberia• Rwanda• Guinea• Mali• Mozambique• Namibia• Philippines• South Africa• South Sudan• Swaziland• Tajikistan• Turkmenistan• Ukraine• Uzbekistan• Vietnam

SPS AA• Afghanistan• Kenya

Objectives of the Session

• At the end of the presentation, participants should be able to

• Demonstrate how regulation affects access to medicines

• Identify the status of medicines regulatory authorities in Low and Middle income Countries (LMICs)

• Describe examples of strategies for strengthening regulatory authorities

• Describe key challenges in strengthening regulatory authorities in LMICs

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“Medicines regulation is needed to ensure that all pharmaceutical products on the market are safe, effective and consistently meet approved quality standards”

- (WHO Policy Perspective on Medicines, 2003)

Why Regulate Medicines?

• Need to ensure only efficacious and quality medicines in the market

• Ensuring only qualified dispensers are providing services ensuring

• Ensuring that establishments that store, distribute and dispense medicines maintain the quality medicines

• Regulating medicine prices to assure affordability and access

• Monitoring adverse drug effects and regulating medicine promotion

“to protect the public, to protect providers and to achieve optimal treatment outcomes”1

Sources: 1.Managing Access to Medicines and Health Technologies (MDS-3) 2. WHO (2003) . Effective medicines regulation: ensuring safety, efficacy and quality. WHO Policy Perspective on Medicines No. 7. Geneva

Functions of a National Drug Regulatory Authority

• Quality Control • Inspection• Pharmacovigilance• Market Authorization• Control of Clinical Trials• Licensing

Source: WHO (2003). Effective medicines regulation: ensuring safety, efficacy and quality. WHO Policy Perspective on Medicines No. 7. Geneva.

The Current Status of Regulatory Authorities Globally

• 20% of the 191 World Health Organization (WHO) member states have well developed drug regulation system.

• 50% implement drug regulation at varying levels of development and operational capacity.

• 30% either have no drug regulation in place or а very limited capacity that hardly functions.

Source WHO: http://www.who.int/medicines/services/counterfeit/overview/en/index1.html

The Current Status of Regulatory Authorities in LMICs• Every country has or is working on establishing a

regulatory authority

• 65% of National Medicine Regulatory Authorities (NMRAs) in African countries were departments under the Ministry of Health with little or no autonomy

• 15% of the countries had all five main functions of an regulation (pharmacovigilance, marketing authorization, quality control, inspection and licensing)

Source: WHO (2010) Assessment of medicines regulatory systems in sub-Saharan African countries

Current State of Regulatory Authorities (2)

Current State of Regulatory Authorities (3)

Challenges of Regulatory Authorities in LMICs• Weak regulatory capacity

• Outdated legislation and poor enforcement of laws; • Bureaucratic bottlenecks• Lack of personnel (numbers and skills)• Inadequate/inefficient information systems• Lack of sustainable sources of funding

• Lack of autonomy• Lack of platforms/mechanisms to share regulatory information • Duplication of effort across countries in the same geographical

area• Insufficient medicine related information for consumers and

prescribers

Challenges of Regulatory Authorities in LMICs (2) • Unethical marketing practices • Insufficient pharmacovigilance efforts• Code of Ethics and transparency

Compounding factors • Non-availability of essential and appropriate medicines • Non-availability of appropriate formulations• Low levels of local production and • Lack of reliable suppliers• The high cost of medicines

Medicine Regulatory Challenges to Access in Medicines

Source: Seiter, A. (2010) A practical approach to pharmaceutical policySource WHO: ttp://www.who.int/medicines/services/counterfeit/overview/en/index1.html

Inadequate, ineffective or weak drug regulatory control promotes; unregulated importation, manufacture and distribution of medicines results in;

• Increased availability and use of counterfeit and substandard medicines

• Fewer medicine options available on the market• Increases the cost of care

• Irrational use of medicines and poor therapeutic outcomes• Increased risk of antimicrobial resistance

• Public mistrust in the healthcare system

Linking Medicine Regulatory Challenges to Access in Medicines (2)• Harmful prescription and medicines use practices e.g.

medication errors

• 26.4% incorrect ART regimens prescribed; • 19.8% potential drug-drug interactions or

contraindication present; and • 16.6% duration and/or frequency of medication

inappropriate. (Agu, Oqua, Adeyanju et al, 2014)

Overall impact of a weak regulatory system• Limited access to safe and efficacious medicines • Poor health outcomes

Regulatory Interventions that have Improved Access to Medicines: Tanzania’s ADDOs

• In 2001, 75% of population lived in rural areas

• Registered pharmacies were mostly located in urban centers

• Duka la dawa baridi (unregulated drug outlets authorized to sell Over the Counter (OTC) medicines only)• Low quality of service• Widely available counterfeit

medicines

Accredited Drug Dispensing Outlets

incentives+ accreditation + regulation = increase demand and availability of quality medicines

Source: MSH (2001 ) Access to Essential Medicines: Tanzania

Quality Assurance in Brazil

71 samples of TB drugs (Rifampicin, Isoniazid, Pyrazinamide etc.) were collected and 70 analyzed for quality

• Low quality batches were recalled

• Manufacturers were notified• Investigation of quality

issues and impact on drug safety and efficacy

• Workshop to address discrepancies in results and methods for rifampicin quality testing

Source: Lee, D (2013). Quality Assurance for Essential Medicines. Strengthening Medicines Regulatory Systems Abroad: Adapting Messages from Recent IOM Consensus Studies for Disease Control Priorities, Third Edition. National Academy of Sciences.

Registration of Medicines in Namibia

• Increased demand for ARVs

• September 2004~1000 pending applications for medicines49 ARVs on market but few combinations and pediatric products

• Inefficient processes and lack of skilled staff

• New policy to prioritize ARV applications & streamlined registration processes↓ registration time decreased from 13 months to 4 months

• Website was developed to improve transparency

• PharmaDex® used to manage review process1392 applications for new medicines were evaluated in the first year

14 ARVs were approved

InterventionsScenario

Source: Strengthening Pharmaceutical Systems (SPS). 2009. Pharmaceutical Management Interventions that Improve Country Health Systems: The Strengthening Pharmaceutical Systems Program. Arlington, VA: Management Sciences for Health.

Strengthening Medicine Regulatory Authorities • Pre-qualification • Regulatory Harmonization• Governance• Human resources – numbers and skills • Financing - Regulatory fees have potential to fund

NMRA functions• Service delivery –ensuring compliance to guidelines• Information systems

Source: World Bank (2012) Global Medicines Regulatory Harmonization Discussed

Challenges in Implementing Interventions to Strengthen National Regulatory Authorities • The process of changing laws and policies is long

• Limited implementation of revised policies

• Interrelated constraints that require a wider reform – to achieve the recommended changes

• Lack of capacity to implement and follow-up recommended interventions

• Limited or no collaboration between Ministries of Health, National Universities and other stakeholders

• Lack of long-term structured interventions

Key Points

• Weak regulation of medicines results in limited or unsafe access to medicines

• The functions of regulatory authorities are integral to ensuring circulation of quality medicines

• Centralization of these functions and considering a range of options will enhance regulation of medicines

• A key factor to success is the legal authority and capacity to perform these functions

• Thank you

References• Agu KA, Oqua D, Adeyanju Z, Isah MA, Adesina A, et al. (2014). The Incidence and Types of Medication Errors in Patients

Receiving Antiretroviral Therapy in Resource-Constrained Settings. PLoS ONE 9(1): e87338. doi:10.1371/journal.pone.0087338• Barrington, J, Wereko-Brobby, O, Ward, P, et al (2010). SMS for Life: a pilot project to improve anti-malarial drug supply

management in rural Tanzania using standard technology. Malaria Journal 2010, 9:298 http://www.malariajournal.com/content/9/1/298

• Lee, D (2013). Quality Assurance for Essential Medicines. Strengthening Medicines Regulatory Systems Abroad: Adapting Messages from Recent IOM Consensus Studies for Disease Control Priorities, Third Edition. National Academy of Sciences.

• Management Sciences for Health (2001). Access to Essential Medicines: Tanzania. Retrieved from http://projects.msh.org/seam/reports/CR022304_SEAMWebsite_attach1.pdf on February 24, 2014

• Management Sciences for Health (2011). MDS-3: Managing Access to Medicines and Health Technologies. Sterling, VA. Kumarian Press.

• Seiter, A. (2010) A practical approach to pharmaceutical policy. Retrieved from http://www-wds.worldbank.org/external/default/WDSContentServer/IW3P/IB/2010/06/22/000334955_20100622050742/Rendered/PDF/552030PUB0Phar10Box349442B01PUBLIC1.pdf on February 24, 2014

• SIAPS Program (2013). Comparative Analysis of Pharmacovigilance Systems in Five Asian Countries. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.

• Strengthening Pharmaceutical Systems (SPS). 2009. Pharmaceutical Management Interventions that Improve Country Health Systems: The Strengthening Pharmaceutical Systems Program. Arlington, VA: Management Sciences for Health.

• WHO (2003). Effective medicines regulation: ensuring safety, efficacy and quality. WHO Policy Perspective on Medicines No. 7. Geneva. Retrieved from http://apps.who.int/medicinedocs/pdf/s4921e/s4921e.pdf on February 24, 2014

• WHO (2010) Assessment of medicines regulatory systems in sub-Saharan African countries: An overview of findings from 26 assessment reports. Retrieved from http://apps.who.int/medicinedocs/en/d/Js17577en/ on February 24, 2014

• World Bank Group (2012) Global Medicines Regulatory Harmonization Discussed. Retrieved from http://www.worldbank.org/en/news/feature/2012/10/18/gGlobal-medicines-regulatory-harmonization-discussed on February 27, 2014

Interactive Questions

1. How would strengthening of current regulatory systems enhance access to medicines?

2. In recognition of the challenges facing regulatory authorities, what are the key recommendations you can give to governments in LMICs?