access & regulation of medicines · mcc mandate 4 regulation of medicines based on safety...

REGULATION OF MEDICINESIN SOUTH AFRICA

POLICY & LEGISLATIVE FRAMEWORK

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National Drug PolicyMedicines and Related Substances Act of 1965

to provide for:- The establishment of the Medicines Control

Council (MCC)- The registration of medicines and related

substances for human and animal use- The control of medicines and scheduled

substances

LEGISLATION

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Medicines & Related SubstancesAct, 1965 (Act 101 of 1965) Provides for– Prohibition of sale of medicines which are

subject to registration and are not registered Sell means sell by wholesale or retail and includes import,

offer, advertise, keep, expose, transmit, consign, convey, ordeliver for sale, authorise, direct or allow a sale, or prepareor possess for purposes of sale, and barter or exchange orsupply or dispose of to any person whether for aconsideration or otherwise

MCC MANDATE

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Regulation of medicines based on safety efficacy and quality Approval and management of clinical trials Pharmacovigilance Post- marketing surveillance Licensing manufacturers, wholesalers, importers and

exporters Provision of information Control Aspects: Who may manufacture, distribute,

prescribe, dispense, import, export, etc Effective law enforcement

HOW THE MCC WORKS

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Evaluators drawn from Academia, Research Institutions,Practice settings, very few in-house Eight Expert Peer Review committees meet every 4-6 weeks GMP / GCP / GWP / GPhP inspections Sub committee ad hoc working groups when necessary MCC meeting every 6 weeks for decision making Registrar keeps register of all medicines Registered products and guidelines on MCC website

PRO ACCESS FLEXIBILITIES IN LAW

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Provision for- sale of an unregistered medicine- Authorisation in writing to a person to sell during a

specified period to any specified person or institution aspecified quantity, for a specific purpose of the use ofsuch medicine Compassionate use Investigational drug (Clinical Trial) Assumes treating practitioner will monitor patient closely

and motivate why an unregistered medicine must be used Patient must be informed that the drug is not

registered and sign informed consent form

PRO ACCESS FLEXIBILITIES IN LAWcont.

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section 15 C Enables parallel importation Enables compulsory licensing read with Patents Act Need for permit and registration Read with Patents Act, enables Bolar type provision

Competitions Act prevents abuse of dominance inrelation to intellectual property rights

ACCESS ENABLING CLAUSES

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Provision for Expedited registration process for medicines on the

Essential Medicines List and Medicines containing new chemical entities that are

considered essential for national health

Provision for-Exclusion of any drug from the operations of Act 101-

PRESERVATION OF SECRECY

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section 34No person shall, except for The purpose of the exercise of his powers The performance of his functions For the purpose of legal proceedingsWhen required to do so by any competent court of

lawWith the written authority of the Director General

PRESERVATION OF SECRECY cont….

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Disclose to any other person any information acquiredby him in the exercise of his powers or the performanceof his functions under this Act and Relating to the business or affairs of any person Or use such information for self-gain Or for the benefit of his employer

CURRENT ENABLING REGULATORYINITIATIVES

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Members of the Pharmaceutical InspectionCo-operation Scheme (PIC/S)

Recognise the WHO GMP inspection reports Agreement for sharing information with FDA Alerts from Europe, FDA & the WHO Provide for Abbreviated Medicine Registration Procedure in

the Guideline Documents Expert reports on safety efficacy and quality as well as CPP from

countries recognised by the MCC Full dossier still required Few applicants use it

CURRENT CHALLENGES

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Small country of 50 million people Inspection of starting material sites Ensuring seamless end to end supply chain tracking Experience in inspecting Good Manufacturing Practice

(GMP) in vaccine and other biological productmanufacturing sites – few in-country sitesMicrobiologyDestructionOperator protectionCleaning validation

CURRENT CHALLENGES cont.

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Demand for evaluation towards marketauthorisation during the development phase –afirst for us New type of applicant e.g.

Product Development Partnerships Scarcity of resources demands efficiency Pressure from a public health perspective to

speed up evaluation without sacrificing safety,efficacy and quality

EMERGING CHALLENGES

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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

companion diagnostics

WHERE ARE WE WITH REGULATION OFBIOSIMILARS

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Guideline applicable to biological medicines containing wellcharacterized recombinant DNA-derived therapeuticproteins that can be shown to be similar to a biologicalmedicine registered in South Africa Largely similar to EMA Guideline in relation to quality, non-

clinical and clinical data requirements Risk management plan a requirement Not considered to be interchangeable with the reference

product or other medicine of the same class Guideline for monoclonal antibodies being finalised for

comment

REGULATORY CHALLENGES WITHBIOLOGICAL SIMILARS

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Inherent batch to batch microheterogeneity andvariability over time Physicochemical and biological characterization Post-marketing additional indications

extrapolation Changes in manufacturing process Is a Biosimilar therefore a Biosimilar forever or

does it have a lifecycle of its own

REGULATORY CHALLENGES WITHBIOLOGICAL SIMILARS cont….

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Need for factual and unbiased communication onBiological similars with prescribers and funders Information in Biosimilar label for the benefit of

prescribers – how far to go Information for patients – how far to go

GAPS

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We do not yet regulate medical devices and in vitrodiagnostics – regulations at drafting stage. Currentlyrely on CE mark and appropriate ISO standard.Regulations at drafting stage.We do not yet regulate complementary and alternative

medicines – regulations at drafting stageWe do not yet regulate African Traditional medicines Long evaluation time lines Regulator currently being re-engineered to improve

capacity and flexibility

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 oftracking systems across the supply chain Linkage between regulators and Health technology

assessment

CULTURE

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Does the regulator have a mandate to act on culture andattitudes ? If so, would that be acceptable, permissible or

legitimate? If not regulators, who would be responsible? There may be compliance with technical and legal

prescripts but if the underpinning values are absent,short cuts will be found. Does our culture as regulators need transformation?

WHAT IS THE WAY FORWARD

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Co- operation with other regulators is imperative froman 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?

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

A GLIMPSE INTO THE FUTURE

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Is all this pointing to a global regulatory body? If so what checks and balances are necessary to

ensure national regulatory authorities areresponsible for the benefit /risk assurance fortheir citizens?What frameworks are necessary to ensure

vigilance, responsiveness and appropriateness todifferent circumstances are maintained? How will growth be ensured?

CONCLUSION

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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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ENDMs Mandisa Hela

helam@health.gov.zaSouth Africa