ESSENTIAL MEDICINES
Gavin Steel – National Department of Health
Policy - Section 27 of the Constitution
(1) Everyone has the right to have access to –
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(a) health care services, including reproductive
health care;
(2) The state must take reasonable legislative and
other measures, within its available resources, to
achieve the progressive realisation of each of these
rights.
(3) No one may be refused emergency medical
treatment.”
Policy – National drug Policy (1)
• The goal of the National Drug Policy is to
ensure an adequate and reliable supply of
• safe,
• cost-effective drugs
• of acceptable quality
• to all citizens of South Africa and the rational
use of drugs by prescribers, dispensers and
consumers.
Policy – National drug Policy (2)
Chapter 5. Drug selection
• The selection of drugs on the National
Essential Drugs List will be based on the
following criteria:
• must meet the health needs of the majority of the
population
• sufficient proven scientific data must be available
regarding the effectiveness of any such product
• products should have a substantial safety and
risk benefit ratio
Essential Medicines List
• Divided into 3 categories:
• Primary Heath care
• Hospital care
• Adult
• Paediatrics
• Tertiary and quaternary care
• Primary and hospital care are Standard Treatment
Guideline (STG) based and tertiary is a pure formulary
system.
Essential Medicines List (2)
Current status
Note the list is:
• Generic (INN) based.
• Does not specify formulations and the pack size.
• Makes use of 64 therapeutic classes
Essential Medicines List (3)
Selection of Essential Medicines
• Quality
• Registered medicines.
• Safety
• Clinical trial data
• Pharmacovigilance data
• Effectiveness {not efficacy}
• Evidence based medicine approach
• Cost
• Market analysis
• Pharmacoeconomics
Process
1.
Three year review cycle
2.
Call up notice for comments.
3.
Expert committee reviews STGs:
4.
Chapters sent for comment.
5.
Peer review of evidence based submissions.
6.
Publication:

STG Book and cell phone application.

Formulary

Medicines review
Process (2)
 Peer review is a critical component:
• Technical subcommittees
• National Essential Medicines List Committee
• National Department of Health Programmes.
• Universities.
• Provincial PTCs.
• Clinical societies.
• Medical schemes.
Process (3)
• Medicines
• Identified as an integral component of the STG
• Technical medicine report
• Background, quality of the evidence, effectiveness, safety.
• Once effectiveness and safety have been established cost is considered.
• Pharmacoeconomic review
• Market intelligence to establish input costs.
• Generic preferred due to competition
• Modelling as required.
• Evidence and costs and reviewed from a practice perspective and
recommendation is made.
Process (4)
• Value of an evidenced based medicine approach
• Transparency
• Contributes toward the management of conflict of interest
• Decisions based on a holistic perspective of the evidence as
opposed to the most recent trial
• Conflict resolution
• Increased “buy in” on the ground.
• Promotes effectiveness as opposed to efficacy based decisions
• Remember Decision = Evidence + values
• Reviews can therefore be translated into formularies at the
Provincial or Medical Scheme level.
Medical Schemes and the EML
• Provision has been made for inclusion of medical
scheme experts on the technical sub committees.
• Medical schemes included in peer review.
• EML serves as the basis for formularies with
schemes.
• Training at medical schools is EML based so the
medicines are know to all professionals.
• NHI contracted Prescribers will be able to
integrate between systems.
Coalition of Leadership
• Pharmaceutical industry’s marketing
machinery is based on Key opinion Leaders
(KoLs).
• Discordance between the public and private
sector leads to disorder and we end up at the
mercy of the clam pharmaceutical marketing
machinery.
• Participation in the EML is a logical coalition
of leadership.
Important Medicines Policy Directions for
medical Schemes.
• Recent government gazette on market inducements
by the pharmaceutical industry.
• This neutralises the competitive advantage.
• CCMDD – Central Chronic Medicines Dispensing and
Distribution program.
• Supply chain reforms.
• Direct deliveries.
• Cross docking.
• Track and trace.
THANK YOU