THE MCC
Today and the future
Mandisa Hela
Let us recap on OBLIGATIONS
• Public safety & protection through ensuring efficacy,
safety & quality of medicines throughout their
lifecycle
• Risk assessment – minimization of harm and
maximization of benefit
• Timely access to medicines & timely action on safety
& quality
• Transparency & accountability
• Responsiveness
• Capacity to regulate
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How is the MCC doing ?
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Quality of reviews – well
Members of PICS
Supply chain integrity - reasonable
Timeliness – poor
Transparency – limited
Responsiveness – needs improvement
Capacity – suboptimal
Where did we go wrong ?
• Current structure conceived more than 40
years ago
• Over - reliance on external experts
• Internal technical expertise limited –
Government department
• Government implemented pro-access policies
without doing an impact assessment,
analysing and adapting affected units
Gaps
• Do not regulate complementary and alternative
medicines
• Do not regulate African traditional medicines
• Do not regulate medical devices and in vitro
diagnostics
• Do not regulate cosmetics
• Do not adequately regulate blood products and
antivenins
• Do not adequately regulate adequately starting
materials - amending legislation
HOW ARE WE FILLING THE GAPS
• Establishment of SAHPRA as public entity
Regulation of orthodox medicines
Regulation of complementary and alternative
medicines
Regulation of African traditional medicines
Regulation of medical devices and in vitro
diagnostics
Regulation of foodstuffs and cosmetics
How are we filling the gaps ? cont.
• Increasing internal capacity
 Numbers
 Skills base
 Attitude
 Improve peer review system – frequency of meetings
 Specialised areas -retainer system
 Reorganise the appeal process
• Cooperation with recognised regulatory
authorities on cutting edge issues
Current challenges
• New technologies which respond to
conditions exclusively or overwhelmingly
prevalent in our country e.g. MDR and XDR TB
• New type of applicant e.g.
Product Development Partnerships
• Balancing early access to new drugs with the
need for comprehensive data
• Managing newer technologies e.g. biosimilars
• Managing borderline devices or medicines
• Maintaining access for older molecules
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Emerging challenges
• Regulation of advanced therapy
medicinal products
 Gene therapy medicinal products, Tissue engineered
products , biologicals containing GMOs
 Combined products with devices used as excipients
or carriers
 Emerging / evolving areas e.g. Advanced therapies
with accompanying diagnostics
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What is happening globally?
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Work sharing among regulators
Co-evaluation
Abridged methods that avoid duplication of effort
In relation to supply chain integrity:
electronic symbology initiatives to ensure
interoperability of tracking systems across the
supply chain
• Linkage between regulators and Health
technology assessment
• Involvement of the public in regulation
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What is the way forward ?
• Co- operation with other regulators is imperative
from an efficiency, capacity and responsiveness
point of view
• How?
What is in the tool box?
What frameworks do we need?
• Are currently available tools sharp enough? Are
they robust enough?
What can we adapt to attain a perfect fit to our
needs?
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Food choices
Food choices
Food choices
Stepping Stones
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Shared vision
Consistency, transparency and responsiveness
Communication, education & training
Common standards
Enabling Legal instruments
Coordination & cooperation
Trust & mutual respect
A pinch of optimism, an ounce of patience and a
healthy dose of perseverance
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A glimpse into the future
• Is all this pointing to a global regulatory body?
• If so what checks and balances are necessary
to ensure national regulatory authorities are
responsible for the benefit /risk assurance for
their citizens?
• What frameworks are necessary to ensure
vigilance, responsiveness and appropriateness
to different circumstances are maintained?
• How will growth be ensured?
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Conclusion
• Prioritise the public good
• No one can do it alone
• Familiarisation with global initiatives is a
MUST
• Good regulatory principles still apply – It is
about accurate data, data elements, trust,
responsiveness, sharing, consistency &
transparency
• Improve on communication and legitimacy
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Conclusion cont.
• Trust is rebuilt by focusing not on what the
other person did or did not do but on
critiquing one's own behavior, improving one's
trustworthiness and focusing attention not on
words and promises but on actions, attitudes,
and ways of being.
Kenneth Cloke and Joan
Goldsmith
The Art of waking people up
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