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THE MCC. Today and the future Mandisa Hela. L et 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

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The mcc


Today and the future


L et us recap on obligations
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


Capacity to regulate

H ow is the mcc doing
How is the MCC doing ?

  • Quality of reviews – well

  • Members of PICS

  • Supply chain integrity - reasonable

  • Timeliness – poor

  • Transparency – limited

  • Responsiveness – needs improvement

  • Capacity – suboptimal

W here did we go wrong
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

G aps

  • 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

H ow are we filling the gaps cont
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

C urrent challenges
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

E merging challenges
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

W hat is happening globally
What is happening globally?

  • 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

W hat is the way forward
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?

S tepping s tones
Stepping Stones

  • 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

A glimpse into the future
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?

C onclusion

  • 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

Conclusion cont
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