New BEE Rules for Health Sector

Introduction

SAHPRA’s is required to implement integrated socio-economic strategies to ensure viable economic empowerment of all black people including Woman, Youth, People living with disabilities.

The objectives of this policy are to:

A new policy was drafted with the intention to govern the issuing of licenses for health product manufacturing, distribution, imports/exports, and related products / services. This policy is based on the following principles:

• Contributing to economic transformation for meaningful black participation in the economy.
• Facilitating significant changes in licensee management structures.
• Encouraging license applicants to adhere to the B-BBEE Act, leading to BEE empowerment.

Scope:

This policy strives to take BEE compliance into consideration during the application process and issuing of licenses. The new guidelines will establish how SAHPRA will determine criteria for license issuance under section 22c of the Medicines Act.

It is anticipated that this policy will not impact the existing SAHPRA registration process for health products but be complimentary to current regulations and the BEE Codes of Conduct.

According to the official SAHPRA policy CEO00, a 2-phased approach will be followed:

Phase 1 (1 year process)

• SAHPRA will require an applicant to submit its B-BBEE level certificate when applying for a license. The effective date is yet to be determined.
• SAHPRA will verify the B-BBEE level status.
• Should an applicant fail to submit its B-BBEE level certificate, or the certificate not be verifiable, SAHPRA will not issue a license to such applicant.
• SAHPRA will utilize the information gathered to understand the current industry structure, and health products supply, to formulate a long-term plan.
• SAHPRA will then develop, in consultation with the industry, and finalise criteria to be applied when license applications are reviewed and eventually issued.

Phase 2 (Post year 1)

• SAHPRA will utilize the applicant B-BBEE level as per the approved criteria to review and issue licenses.

What does it really mean?

Forthcoming regulations and compliance requirements are coming, it is a matter of when will it be effective. In BEE Analyst’s experience, the best approach will be to be pro-active, don’t wait until SAPHRA drops a BEE bomb on your head. Start with your preparations now. Contact BEE Analyst for assistance.

Contact: Jaco Jacobs

Mobile: 082 585 6867

Office: 012 997 0037

E-mail: consult@beeanalyst.co.za