Gilles Forte Policy Access and Use Team Department for Essential Medicines and Health Products World Health Assembly Resolution 6722 Access to essential medicines Recognize the importance of effective national medicines policies and their ID: 731422
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Slide1
Access
to
affordable and quality assured essential medicines
Gilles Forte
Policy
, Access and Use Team
Department for Essential
Medicines and Health ProductsSlide2
World Health Assembly Resolution 67.22 Access to essential medicines
Recognize the importance of effective national medicines policies, and their implementation under good governance for
improving access to affordable, safe, effective, and quality-assured essential medicinesWHO Model Essential Medicines List recognized as a valuable tool that enables countries to identify a core set of medicines which need to be accessible to provide quality medical care – special mention of children. Strengthening monitoring mechanisms, in order to better understand the causes of
essential medicines shortages
, and
develop
strategies to prevent and mitigate
shortages
This resolution provides
WHO with
a renewed mandate to continue to support MS in improving
access
in line with UHC,
the
MDGs and the NCD global action plan. Slide3
Access to
affordable and quality
assured
essential medicines
1. Selection
and responsible
use
4.Reliable & efficient supply chain
2.
Affordable
prices &
sustainable
financing
3. Assured quality
Policy &
Governance of systems Slide4
Selection of essential medicines based on scientific evidence Guiding principle:
Identify a limited range of carefully selected essential medicines leads to better health care, better medicines management, and lower costsDefinition: Essential medicines are those that satisfy the priority health care needs of the populationSelection:
Selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.Slide5
The WHO Model Essential Medicines List
1. WHO Model EML: 1977 1
st Model List published, 208 active substances - List revised every two years by WHO Expert Committee - 2002 Revised procedures approved - WHO (EB109/8) - Last revision -April 2013
:
374
medicines (
278
paediatric) Guideline
for updating country EMLGlobal database on evidence Interagency New Emergency Health KitSlide6
Responsible use of medicinesAssess whether prescribing is in line with best-practice treatment guidelines (WHO supports development of treatment guidelines)Health care professionals and patients/consumers need accurate & independent information
about medicines Promotional practices of pharmaceutical industry need to be monitored (WHO has developed criteria for ethical promotion)Concerns about antimicrobial resistance have given a renewed focus to the responsible use of medicinesSlide7
Access to
affordable and quality
assured
essential medicines
1.
Responsible
Selection and use
4.Reliable & efficient supply chain
2.
Affordable
prices & Sustainable
financing
3. Assured quality
Policy &
Governance of systems Slide8
Affordability of essential medicinesIn low and middle-income countries much of the health expenditure is out-of-pocket (OOP) Aim of UHC is to avoid high OOP expenses that put care out of the reach of many patients and impoverish families
While availability of medicines is higher in the private sector, also the costs of medicines are higher Taxes, government tariffs and mark-ups applied to medicines reduce affordabilityOne measure of affordability is how many days wages are required to purchase a course of medicines or one month of treatmentSlide9
9
Low public sector availability leads patients to the private sector, where medicines are
less affordableSlide10
Access to essential medicinesHow does WHO contribute ?
Affordable prices and financing
WHO/HAI tools for assessing medicines prices, availability & affordability (medicines basket under revision e.g. NCDs) WHO/HAI database on prices and availabilityWHO guidelines on pricing policies e.g. generics, duties, taxes, markups, reference pricingTechnical support to countries for pricing, financing and reimbursement policies and mechanisms Slide11
Access to
affordable and quality
assured
essential medicines
1. Rational
Selection and use
4.Reliable & efficient supply chain
2.
Affordable
prices & Sustainable
financing
3. Assured quality
Policy &
Governance of systems Slide12
Access to essential medicines of assured qualityStrong National Regulatory Authorities (
NRAs) to ensure effective regulation of manufacture, distribution and use of medicines & other health technologiesLegal, administrative and technical aspectsLicensing of manufacturers, importers, wholesalers, suppliersAssessing safety, efficacy and quality; issuing market authorizationInspection and surveillance activities
Controlling & monitoring quality, promotion, adverse reactionsProviding independent information to professionals and the publicRegional harmonisation initiatives e.g. EMA, EACSlide13
Access to essential medicines of assured quality How does WHO contribute ?
WHO Expert Committees: Quality Assurance guidelines e.g. GMP, GDP, MQAS, International Pharmacopeia etc. Tools & training for Rapid Alert System for counterfeit medicines Tool for assessment
of the medicines regulatory system in countries (plan for a computerized assessment tool covering medicines, biologicals including vaccines, diagnostics and medical devices) Pharmacovigilance – monitoring network with Uppsala Collaborating CenterPre-qualification of
finished pharmaceutical products, active pharmaceutical ingredients,
quality control laboratory for international procurement and strengthen countries capacity
Slide14
Access to
affordable and quality
assured
essential medicines
1. Rational
Selection and use
4.Reliable & efficient supply chain
2.
Affordable
prices & Sustainable
financing
3. Assured quality
Policy &
Governance of systems Slide15
Effective procurement and supply systemsSupply chains for medicines are long and complex and require appropriate policies and best practices that are effectively implemented and enforcedAccurate quantification, efficient logistics information and management systems are
needed to avoid stock-outs or over-stocking of essential medicinesRequires trained personnel Minimise vulnerability to
corruption that waste limited health resources, it is important to have transparent processes, institutional checks and balances, codes of conduct for public employees in place Slide16
Inefficiencies and unethical practices can occur throughout the medicines supply chain
Promotion
Conflict
of interest
Pressure
Falsification
safety/
efficacy data
Bribery
Patent
R&D and clinical trials
Manufacturing
Inspection
Distribution
Registration
SelectionProcurement & import
Pricing
Prescription
DispensingPharmacovigilanceTheftsOver-invoicingCounterfeit/substandard
CollusionUnethical donationsUnethicalpromotionHigh pricesInappropriate forecasting
Inappropriate
useLossesSlide17
Access to essential medicines How does WHO contribute ?
Reliable and efficient supply systems -Tools for indepth assessment
of procurement and supply chain-Guidelines for medicines procurement (IPC)-Guidelines for medicines donations & disposal
of
pharmaceuticals
-Model
Quality
Assurance System for
procurement agencies (through Expert Committee
)-Good Governance of the supply chain-Technical support to countries for policies and best practicesSlide18
Access to essential medicines:an unfinished agendaDespite some improvements towards MDGs, problems with access to key essential medicines remain:
Patients with HIV, TB, malaria untreated/sub-optimally treated MDR-TB poses significant threats to management of TB
Unmet needs of mothers and children for essential medicines and reproductive health commoditiesGlobal challenges of non-communicable diseases; poorest countries are dealing with double burden of communicable and NCDsProviding access to cancer therapies and other high cost medicinesManaging responsible use of antimicrobials to deal with problems of antimicrobial resistanceSlide19
WHO mandate within the International Drug Control Conventions1961 Single Convention on Narcotic Drugs (Article 3)1971 Convention on Psychotropic Substances (Article 2)Both Conventions require
(art 3 SC; art 2 PsSubstC)WHO to examine risks of dependence and harm due to use of specific substances – WHO ECDD
WHO to consider therapeutic usefulness of the substancesRecommandations from ECDD for international control made to CND for further decision (art 5.2 PsSubstC
)Slide20
Use of Controlled Medicines
Ergometrine and ephedrine: emergency obstetricsBenzodiazepines
: anxiolytics, hypnotics, antiepilepticsPhenobarbital: Antiepileptic
Opioid analgesics:
e. g. morphine
moderate and severe pain
Long-acting
opioid agonists:
methadone, buprenorphine
treatment of opioid
dependenceSlide21
Research showsthat in 2010, worldwide an estimated 4.65 billion people
were living in countries with low to non-existant access to controlled
medicines (on a total world population of 7 billion) (Scholten W and Duthey B, J Pain and Symptom Management, 2014; 47(2):283-297)The consumption of opioid analgesics remains inadequate in most parts of the world and, as a result, patients with moderate and severe pain do not receive the treatment they need.66% of the world population has virtually no consumption, 10% very low, 3% low,4% moderate, and only 7.5% adequate. For 8.9%, no data was available.
Slide22
From: B
Duthey
and W
Scholten.
J Pain
Sympt
Manag
.Slide23
Barriers to access to controlled medicinesMedicines selection and use - inefficiencies
Prices, affordability and financingProcurement and supply
chainInsufficient training for prescription and use Attitudes Excessive fear for abuse and dependenceExcessive fear for diversionProblems related to assessment of medical needs Slide24
Legislative barriersLimitations on prescriptions and administrationDuration
Maximum dosageAdministration of medicines restrictedSpecial prescription formsLimitation of outletsLimitations on who is allowed to prescribeSlide25
Therapeutic Guidelines for better useWHO Guidelines for clinical management of persisting pain in children: a
two step approach: Mild pain: non-opioids
Moderate and severe pain: opioid agonists (e.g. morphine, oxycodone, fentanyl etc.)WHO Guidelines on opiods dependence: Require availability
of
methadone
(first
choice
) and
buprenorphineOther WHO pain guidelines to followPersisting Pain in AdultsAcute PainSlide26
WHO Policy Guidelines21 Guidelines:Content of drug control legislation and policy (2 GLs)
Authorities and their role in the system (4 GLs)Policy planning for availability and accessibility (4 GLs)Healthcare professionals (4 GLs)Estimates and statistics (3 GLs)
Procurement (3 GLs)Other (1 GL)http://www.who.int/medicines/areas/quality_safety/guide_nocp_sanend/en/index.html
Ensuring Balance in National Policies on Controlled Substances,
Guidance for accessibility and availability of controlled medicines
(Geneva 2011
) - while preventing misuse and diversionSlide27
ATOME:
Objective: To i
mprove
access
to
controlled
medicines
in 12 countries in particular for opioids for:
Analgesia
;
Treatment of opioid dependenceAnalysis of country-specific barriers to opioid accessibilityCountry teams worked on a national strategic action planTraining of legislation analysis / In-depth review of legislation relevant to controlled substancesPreparation of reports with targeted recommendations for each countryDiscussion of implementation of recommendations during national workshopSlide28
Operationalizing across the 3 organizational levels
HQ (PHI, TSN, RSS, PQ, SAV, PAU)
Countries
EURO
SEARO
WPRO
AMRO
AFRO
EMRO