creating sustainable value

PRESENTATION TO THE HONORABLE MEMBERS OF THE HEALTH PORTFOLIO COMMITTEE OF

PARLIAMENT ON THE OCCASION OF THE PUBLIC HEARINGS IN RESPECT TO THE MEDICINES

AMENDMENT BILL

BY PHARMACEUTICALS MADE IN SOUTH AFRICA

(PHARMISA)

PARLIAMENT, CAPE TOWN 05 AUGUST 2008

PHARMISA

• Alliance of SA indigenous Pharma Manufacturers that manufacture 50% or more of their products in SA

• Represent approximately 20% of SA market in value and approximately 65% of its manufacturing capacity and production assets

• Has the strongest empowerment credentials

• Our main focus is creating an environment conducive to…

Boosting local manufacture and lessening dependence on imports

Job creation, skills retention & growth and SA technology enhancement

Ensures supply security

Accelerates sector transformation and industrialisation

Provides certainty and predictability to investors & stakeholders

Building a strong export base in order to save on Forex

… Our response to the Amendment Bill is based on the above principles…

MEDICINES AMENDMENT BILL

• PHARMISA supports the Bill and its intentions

• In our view the Bill will enhance access to Healthcare for all those who live in SA

• Our comments are therefore geared at enhancing the objects of the Bill and assisting in re-introducing predictability and certainty to an “at the moment” uncertain sector

• Our comments are confined to Bill, we have however also tried to address legislative gaps as we see them

ISSUES FOR DISCUSSION

ISSUE PROPOSAL1. Lack of empowering provisions in respect of key timelines for registration

Introduce empowering provisions, that enable Regulations to set out timelines for registration

New Chemical Entities = 12 Months

Biologicals = 12 Months

Generics = 6 Months

Clinical Trials = 30 Days

Emergency Unregistered = 24 Hours

2. Two Phase Registration Balance needs to be achieved between minimal scientific interference and public interest.

Minister of Health should have no discretion on scientific evaluation, only (the Authority should) and any discretion on Public interest should be applied consistently, after consultation with the appropriate experts & with fill accountability to Parliament.

For example, S22G Regulation 8 & 9 Annual Price Increase has been applied inconsistently which has let to uncertainty in the Sector with a denting of Investor confidence.

3. S18C – Marketing Code should be mandatory – eliminate many of the market perversities

S18C should compel the Minister to make provisions for the Marketing Code, rather than the current language which does not make this mandatory.

The word “may” in S18C needs to be replaced with “shall” in order to give effect to this

ISSUES FOR DISCUSSION

ISSUE PROPOSAL4. Data Protection Attempts at introducing data protection, will in effect

increase patent lifecycles and reduce access to treatment

5. Section 42 (1) & (2)Transitioning of old into new, in order to ensure that work in progress is not lost

The transitioning measures set out in the S42 need to make more specific provision for existing application pending Registration to be transferred to the new Authority without any further loss in timing.

6. Schedule 0 exemption in respect of S18A, B and S22G of the Amendment Bill

Schedule 0 are currently exempt on sound reasons, this needs to be carried through in the new Bill

OUR CONTRIBUTIONS ARE INTENDED TO:

• Enhance access to treatment

• Contribute towards the creation of a more stable, certain and predictable Healthcare environment, that is conducive to further stimulate investment and growth

• Boost local production capabilities