INTRODUCTION

The Promotion of Access to Information Act (“the Act”) gives effect to section 32 of the Constitution, which provides that everyone has the right to access any information held by the state or by another person, where such information is required for the exercise or the protection of any rights. It seeks to promote a culture of transparency, accountability and good governance.

In furtherance of this objective, Section 51 of the Act requires private bodies to compile a manual,

which will assist persons requesting information (called requesters) in obtaining information from such private body. The manual must contain sufficient detail to facilitate a request for access to a record, a description of the subjects on which the body holds records and the categories of records held on each subject. Any person may request access, including an employee, the public, government or competitors.

It is foreseeable that the Act may be utilised to obtain information in respect of inter alia the following:

Discrimination; Health and safety; Land claims; Environmental issues; Unfair competition; Financial and Commercial information.

Click on www.acts.co.za/Prom_of_Access_to_Info/ to view the act

Part 1. [Section 51(1)(a) of the Act]

COMPANY INFORMATION AND CONTACT DETAILS

Roche Products (Pty) Ltd (South Africa) is part of the global Roche Group, with the Holding Company, Roche Holding AG Limited, Switzerland. Roche Products operates through the following Operational Divisional Groups (ODG’s):

Pharmaceuticals (Pharma) – Importation, manufacturing and marketing of pharmaceuticals.

  • Rx Therapeutics – Prescription Medicines
    Roche is engaged in the following therapeutic areas:

- Central nervous system
- Infectious diseases
- Oncology
- Virology
- Cardiovascular diseases
- Inflammatory and auto-immune diseases 
- Dermatology
- Metabolic disorders
- Respiratory diseases.

Diagnostics - Importation and distribution of diagnostic systems and reagents within the following business units:

  • Molecular Biochemicals: molecular and cellular medicines, biotechnology
  • Molecular Systems: products based on the state-of-the-art PCR (polymerase chain reaction) technology
  • Laboratory Systems: chemistry laboratory systems, therapeutic drug monitoring, drugs of abuse testing
  • Patient care: diabetes monitoring and point-of-care

Registration number  - 1947/027044/07

Registered address - 4 Brewery Street , Isando

Postal address - P.O.Box 129 , Isando. 1600

Auditors - KPMG

Chief Executive Officer - Maturin Tchoumi

Company Secretary and duly authorised Information Officer - Rodney Cadwell, Rodney.cadwell@roche.com , Tel: +27 011 9288725

Part 2. [Section 51(1)(b) of the Act] SOUTH AFRICAN HUMAN RIGHTS COMMISSION GUIDE

In terms of Section 10 of the Act, The South African Human Rights Commission (SAHRC) must compile a guide containing information that may be required by a person who wishes to exercise a right in terms of the Act. The guide is intended to assist users in the interpretation of the Act and will become available in August 2003.

The Human Rights Commission may be contacted at:

Address: Private Bag 2700 Houghton 2041,
Telephone: (011) 484 8300
Facsimile: (011) 484 0582
Website: http://www.sahrc.org.za.

Part 3. [Section 51(1)(c) of the Act]

CATEGORIES OF RECORDS WHICH ARE AVAILABLE WITHOUT A PERSON

HAVING TO REQUEST ACCESS IN TERMS OF THE ACT

Click on www.roche.co.za for the Roche South Africa website.

Click on www.roche.com for the Roche Global website.

Part 4. [Section 51(1)(d) of the Act]

RECORDS AVAILABLE IN TERMS OF RELEVANT LEGISLATION

Roche Products (Pty) Ltd. keeps information in accordance with the following legislation:

1. Basic conditions of Employment Act, No. 75 of 1997
2. Companies Act, No. 61 of 1973
3. Competition Act, No. 89 of 1998
4. Compensation of Occupational Injuries and Diseases Act, No. 130 of 1993
5. Customs and Excise Act, No. 91 of 1964
6. Electronic Communications and Transactions Act, No. 25 of 2002
7. Employment Equity Act, No. 55 of 1998
8. Income Tax Act, No. 58 of 1962
9. Insolvency Act, No. 24 of 1936
10. Labour Relations Act, No. 66 of 1995
11. Machinery and Occupational Safety Act, No. 85 of 1993
12. Occupational Health and Safety Act, No. 85 of 1993
13. Promotion of Access to Information Act, No. 2 of 2000
14. Skills Development Levies Act, No. 9 of 1999
15. Stamp Duties Act, No. 70 of 1968
16. Trademarks Act, No. 194 of 1993
17. Unemployment Insurance Act, No. 63 of 2001
18. Value – Added Tax Act, No. 89 of 1991
19. Pharmacy Act, No. 53 of 1974
20. Medicines and Related Substances Control Act, No. 101 of 1965
21. Hazardous Substances Act, No. 15 of 1973
22. Regional services councils Act, No.109 of 1993
23. The Commission for Employment Equity Code of Good Practice on key aspects of HIV/AIDS and Employment, 2000

Part 5. [Section 51(1)(e) of the Act]

5.1 DETAIL OF CATEGORIES OF RECORDS AVAILABLE

5.2 HOW TO REQUEST A RECORD

5.1 DETAIL OF CATEGORIES OF RECORDS AVAILABLE

Regulatory Affairs

  • Information in accordance with the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) as amended excluding Registration Data which is not in the public domain.

Technical

  • Site Master File
  • Applicant Master file
  • Standard Operating procedures
  • Pharma manufacturing standards
  • Batch Manufacturing and packaging records
  • Quality Control records
  • Complaint records
  • Distribution records
  • Technical Agreements
  • Qualification and validation documents
  • Material specifications
  • Investigation records
  • Quality Audit reports- internal and third party/vendors
  • Reject records
  • Technical training records
  • Guide to current Good Manufacturing Practices (cGMP)

Medical

  • Clinical Trials

Human Resources

POLICY INDEX SECTION 1: Company Benefits

  • Allowances
  • Leave
    - Annual leave
    - Maternity leave
    - Miscarriage
    - Adoption
    - Maternity benefits
    - Sick leave
    - Compassionate leave
    - Household moving leave
    - Paternity leave
    - Family responsibility leave
    - Sports leave
    - Unpaid leave
    - Study leave
  • Conditions of Employment 
    - Medical Aid
    - Pension & Provident Fund
    - SACWU national Provident Fund
    - Roche Defined contribution (RSA) Pension Fund

SECTION 2: Company Practices

  • Loans
  • Payroll
    - Deductions
    - Bonuses
    - Payment of salaries
    - Personnel records
  • Termination of Employment
    - Termination of Service
    - Termination of employment
    - Retirement
    - Ad-hoc Practices

SECTION 3: Labour Relations

  • Disciplinary Enquiry
    - General Rules
    - Documentation requirements
    - Parties involved at the Enquiry
    - Preparing for the Enquiry
    - Disciplinary Enquiry Procedure
    - General Notes on Disciplinary Enquiry
    - Appeals and grievances against disciplinary enquiry
    - Disciplinary enquiry
  • Grievance Procedure
    - Definitions, Objective and Guarantee against victimization
    - Procedure to be followed
  • Labour Relations Principles
    General Management of Discipline
    - Introduction
    - Communication of Standards of Conduct and Performance
    - General Principles
    - Procedural and substantive fairness and the penalties for non compliance
    - Types of disciplinary action
  • Incapacity vs. Misconduct
    - Introduction
    - Substantive differences
    - Procedural differences
    - Incapacity
    - Misconduct
    - Disciplinary enquiry
  • Medical Incapacity
    - Ill health, injury or medical incapacity
    - Temporary ill health, injury or medical incapacity
    - Permanent ill health/ incapacity
    - Medical incapacity enquiry form
  • Misconduct
    - Record of verbal warning
    - Written warning form
    - Final written warning for misconduct

POLICIES:

  • Car policy
    - Car scheme and car allowance scheme
  • Poor Work Performance
    - Written warning form – Tools
    - Counseling
    - Appeal form for all disciplinary measures
  • Recruitment procedure
    - Authority to recruit (ATR) form

Finance & Information Technology

- Memorandum and Articles of Association
- Board resolutions and minutes of meetings
- Company act related documents - CM27, 29 and 31
- List of authorised employees and their signing limits
- Invoices from suppliers and to debtors
- Property ownership documents (Title Deeds)
- Asset Registers
- Rental agreements
- Contracts in general
- Bank facility agreements
- Opening of Accounts documentation
- Internally generated journals
- Computer generated journals
- Agreements relating to computer systems & programs
- Asset registers
- Authorised employees & their signing powers
- Minutes of meetings

Public Affairs and Communications

  • Internal Administrative Info:
    - Copies of all payments + supporting documents
    - Contacts - names and telephone numbers
    - Orders/telephone reports
    - Travel Requests
    - Presentations
  • C S I:
    - Declined request replies
    - Sponsored request replies
    - Copies of payment requests
  • Projects:
    - Phelophepa information and correspondence
    - Swiss Business Council
  • General Info:
    - Basel Group Info - International
    - Isando Notice Board Info
    - HIV/AIDS Issues
    - Product issues
    - Universities
    - Copies of IC's
    - Copies of Notices
    - PMA correspondence and info
  • Media Info:
    - Basel Media Notices - Products and Issues
    - Press Issues - Product Q & A
    - Press Issues - General Info
    - Press Releases
  • Literature:
    - Copies of INDABA
    - Back copies of HEXAGON
    - Roche in Progress Booklet
    - We Innovate Healthcare Booklet
    - Roche Presentations
    - The Roche Corporate Design
    - Set of books on design of stationery, flags, signs etc
    - Roche history books eg:
  • Basel 100 year books
  • Roche in South Africa - 50 years
    - Roche Principles
  • Daily News:
    - Newspapers: (kept for + 3 weeks)

HIV/AIDS Workplace Policy

- Purpose, Preamble and General Principles
- Basic information on HIV/AIDS
- Creating a non-discriminatory and caring environment
- Roche HIV/AIDS Programme
- Implementation and Co-ordination responsibilities
- Annexure: Management of occupational exposure to HIV/AIDS

SUB-SAHARA AFRICA

- Contracts - Distributors
- Profile of Division
- Invoices from suppliers
- Invoices to Debtors
- Internally and Computer generated journals
- General Information
- General Export Information/Details
- Promotional Material Information/Details

DIAGNOSTICS

- Key responsible Managers
- Product Information
- Disease / Health information
- Address of branches and contact people
- Roche affiliates
- Social projects
- Career opportunities
- Publication / press releases

5.2 HOW TO REQUEST A RECORD (click on www.acts.co.za/Prom_of_Access_to_Info/ )

  • Section 53 prescribes that the requester must use the prescribed form to make the request for access to a record. This must be made to the head of the private body, or his duly authorised information officer. This request must be made to the address, fax number or e-mail address of the body concerned.
  • The requester must provide sufficient detail on the request form to enable the information officer to identify the record and the requester.
  • The requester must identify the right that he or she is seeking to exercise or protect and provide an explanation of why the requested record is required for the exercise or protection of that right.
  • The head of the private body (or his authorised information officer) must notify the requester (other than a personal requester) by notice, requiring the requester to pay the prescribed fee of R50 before further processing the request. The requester may lodge an internal appeal against the payment of the requested fee.
  • If the request is granted then a further access fee must be paid for the reproduction and the search and preparation of the records for disclosure.
  • The head of the private body will then make a decision on the request and notify the requester on the required form.

Part 6. [Section 51(1)(f) of the ACT]

Not applicable

Part 7. [Section 51(3) of the Act]

AVAILABILITY OF THE MANUAL

Copies of this manual are available for inspection, free of charge, at the offices of Roche Products (Pty) Ltd (see details above); copies are also available from the SAHRC and from the Government printers.

Part 8.

FEES IN RESPECT OF PRIVATE BODIES

  1. The fee for a copy of the manual as contemplated in regulation 9(2)© is R1.10 for every photocopy of an A4-size page .
  2. The fees for reproduction referred to in regulation 11(1) are as follows: 
    a) For every photocopy of an A4-size page - R1.10
    b) For every printed copy of an A4-size page held in an electronic medium - R0.75
    c) For a copy in a computer readable form on;
       I. Stiffy disc - R7.50
       II. Compact disc - R70.00
    d) For a transcription of visual images for an A4-size page - R40.00
        Ditto copy - R60.00
    e) For a transcription of an audio record, for an A4-size page - R20.00
        Ditto copy - R30.00
    The access fees payable by a requester referred to in regulation 11(3) are as follows:
    f) For every photocopy of an A4-size page - R1.10
    g) For every printed copy of an A4-size page held in an electronic medium - R0.75
    h) For a copy in a computer readable form on;
       I. Stiffy disc - R7.50
       II. Compact disc - R70.00
    i) For a transcription of visual images for an A4-size page - R40.00
        Ditto copy - R60.00
    j) For a transcription of an audio record, for an A4-size page - R20.00
        Ditto copy - R30.00
  3. The requested fee payable by a requester, other than a personal requester, referred to in regulation 11(2) is R50.00
  4. To search for and prepare the record for disclosure, R30.00 for each hour or part of an hour reasonably required for such a search and preparation.
  5. For purposes of Section 54(2) of the Act, the following applies:
    a) 6 hours as the hours to be exceeded before a deposit is payable
    b) 1/3 of the access fee is payable as a deposit by the requester
  6. The actual postage is payable when a copy of a record must be posted

Part 9. [Section 53(1) of the Promotion of Access to Information Act, 2000]

REQUEST FOR ACCESS TO RECORD OF PRIVATE BODY

PRESCRIBED REQUEST FORM [Regulation 10]

A. Particulars of private body

Roche Products (Pty) Ltd

B. Particulars of person requesting access to the record

  • The particulars of the person who requests access to the record must be given below
  • Proof of the capacity in which the request is made, if applicable, must be attached.

Full names and surname:
Identity number:
Postal address:
Telephone number:
Fax number:
E-mail address:
Capacity in which request is made, when made on behalf of another person:

C. Particulars of person on whose behalf request is made

This section must be completed only if a request for information is made on behalf of another person

Full names and surname:
Identity number:

D. Particulars of record

Provide full particulars of the record to which access is requested.

E. Fees

  • A request for access to a record, other than a record containing personal information about you, will be processed only after a request fee has been paid.
  • The fee payable for access to a record depends on the form in which access is required and the reasonable time required searching for and preparing a record.
  • If you qualify for exemption of the payment of any fee, please state the reason for exemption.

Access to Info    
 

ROCHE PRODUCTS (PROPRIETARY) LIMITED (South Africa)

MANUAL PREPARED IN ACCORDANCE WITH SECTION 51 OF THE PROMOTION OF ACCESS TO INFORMATION ACT, ACT NO. 2 OF 2000 (“the Act”)