Presentation to the Honourable Portfolio Committee on Health

Amendments to the National Health Act

Bill [B24 of 2011]

Who is PIASAPharmaceutical Industry Association

of South Africa– Longest established trade association in

South Africa representing pharmaceutical companies

– 18 multinational and local companies operating in South Africa

– Supply more than 25% of medicines into the public and private sectors in SA

– Public sector (based on survey results):– 15 companies currently supply a total of

158 products, most of which are used for the treatment of NCDs (137 products) equivalent to 87%.

PIASA members – responsive to health needs of South

Africa 15 companiesEDL = Essential Drugs ListDisease areas: Non-communicable diseasesHIV/TBMaternal and Child Health

Ref: PIASA NHI Submission

PIASA position

PIASA fully supports the implementation of a structure and

standards aimed at ensuring quality of care, which will ultimately protect

patients whilst optimising compliance to standards by all stakeholders

National Core Standards

• An independent National Inspectorate (OHSC) will carry out inspections to determine degree of compliance and issue public report on their findings and a certificate of compliance.

• BUT– Inspection and enforcement mechanisms

already exist for medicines, therefore there may be areas of overlap between OHSC and other regulators

Medicines are well regulated – quality, safety and efficacy controls across the

value chain

Systems and skills already exist to monitor compliance across the value chain managed

by other regulatory bodies

EXAMPLES OF AREAS OF OVERLAP

Domain 1: Patient Rights

• 1.2. Access to information for patients– 1.2.1 Patients are given

the information they need regarding their treatment, their care after discharge and their participation in research where relevant

Current measures• Medicines Act:

– Provision for package inserts for medicines in regulations

– Package inserts approved by MCC

– GCP requires informed consent from clinical trial participants

– Clinical trial protocol approvals by MCC and ethics committees

• Consumer Protection Act, ethical rules, NHA Chapter 2

Core Standards

Domain 2: Patient safety, clinical governance and

clinical careCore Standards• 2.5 Adverse events

– Adverse events or patient safety incidents are promptly identified and managed to minimise patient harm and suffering• Adverse events policy

and procedure– Adverse events are

routinely analysed and managed to prevent recurrence

MCC Guideline• Requires reporting of

adverse reactions related to medicines by healthcare professionals and manufacturers of medicines within specific timeframes in a specified format

Destruction of medicines

MCC Guidelines• Specific requirements

for medicine destruction, including qualified pharmacists to be present to sign off destruction

Bill• Environmental Health

Inspectors also under OHSC– Overlap with MCC and

SAPC inspectors

Independence and accountability

• 79A(1) CEO appointed by Minister• 79A(4) CEO may be removed by

Minister• 79D(1)(b) & 79D(3)… OHSC reports

to Parliament via MoH’s office• 81(A)(9) &(10) Ombud

recommendations via CEO or MoHPIASA recommends direct accountability of

the OHSC to parliament and real independence for the Ombud to make

decisions

Clause 78 vs. 82 vs. 89 – Monitoring vs. enforcement

• 78 - Objects of Office– To monitor compliance to norms and standards– Consideration, investigation and disposal of

complaints• However, functions outlined in the Bill extend beyond

monitoring to include non-certification and fines• 82A – Non-compliance with prescribed norms

and standards– (4)(a)&(b) fines and referral to NPA

• 89(2) – Offences and penalties– Liable on conviction to a fine or to imprisonment

• Including provisions for norms and standards• Inspections and enforcement

Currently for medicines: provisions for norms and standards, monitoring compliance, inspections and enforcement exist under the Medicines Act and the

Pharmacy Act for ALL in the supply chain

Clause 79(2)(e) & 79B – Delegation, Co-operation and

Harmonisation• 79(2)(e) Negotiate co-operative agreements with any

regulatory authority in order to – (i) co-ordinate and harmonise the exercise of

jurisdiction over health norms and standards• 79B(3) CEO may enter into contracts or appoint

expert or technical committees to assist the Office..• Norms and standards exist for medicines that are enforced

by other regulators, MCC & SAPC– Harmonisation provision is not sufficient in detail to deal with

known overlaps with medicine regulatory system – creates legal uncertainty

– Existing and known overlapping jurisdictions on standard-setting and inspections are not dealt with in the Bill

– If not dealt with, it will create confusion in industry from a compliance perspective and duplicate functions that already exist

PIASA proposes that, standard-setting, compliance and enforcement within powers of MCC and Pharmacy Council be excluded, and, where necessary that these bodies are called

upon to evaluate suspected non-compliance with such standards

Clause 79 (1)(b) & 79 (1)(f) –Inspections and QA

• 79(1)(b) inspect and certify health establishments as compliant or non-compliant with prescribed norms and standards or where appropriate and necessary withdraw such certification

• 79(1)(f) Recommend quality assurance and management systems for the national health system to the Minister for approval

• Medicines are registered on the basis of safety, quality and efficacy by the MCC, including– provisions for inspections to ensure the quality of

medicines through good manufacturing practice– provisions for medicine recalls where quality issues

are identified• SAPC & MCC responsible for inspection of pharmacies,

including manufacturing pharmaciesSpecialised skills are required for monitoring and inspection for compliance to standards with medicines standards; inspectors

undergo specialised training to conduct inspections

Conclusion• Medicine value chain is complex and well regulated• Quality, safety and efficacy controls exist across the

medicine value chain• Specialised expert skills as well intimate knowledge of

operational processes are required for inspection purposes– Base qualifications not adequate– Internationally these requirements have become areas

of specialisation• It is recommended that areas of overlap between the

OHSC and MCC and SAPC be carefully reviewed in order to avoid duplication and facilitate adherence to norms and standards to ensure and maintain quality of medicines to protect patients

• For further information, please contact:Kirti NarsaiHead: Scientific and Regulatory AffairsTel: 011-805-5100Email: kirti@piasa.co.za