1. Public Hearings on the Medicines and Related Substances Amendment Bill [B44 – 2008] Presentation to the Portfolio Committee on Health
Cape Town
6th August 2008

2. AGENDA NAPM - Who we are NAPM Position on Proposed restructuring
NAPM Concerns: IP
Two Tier Registration Process
Expediting the registration of generics
Transition period/phase
4. Conclusion
5. Way forward
6. Q & A

3. 1. NAPM – Who we are Vision Mission
The Association aims to champion affordable healthcare by promoting generics
Mission
Promote the Use of Generics
Promote the development of the  South African  Pharmaceutical Industry

4. NAPM Membership
Abex Pharmaceutica Arrow Pharma SA Austell Be-Tabs Biovac Bodene Columbia Dr Reddy’s Laboratories Enaleni/Cipla-Medpro Ferring Medreich SA Merck Generics / Mylan SA Omnimed Pharma Dynamics Pharmafrica Ranbaxy Sandoz Sekpharma Thebe Medicare

5. 2. NAPM Position
Restructuring of the RA - supported by industry
Why??

6. Mandate of the Regulatory Authority
In line with Medicines Act: Safety Quality Efficacy
Issues...
Public interest → constitution / government policies √
Pricing → PC - well-established, up & running √
Intellectual Property → Patent Act:
~ conducive to emerging economy √
~ Support public health issues √

7. Functioning and processes of SAHPRA
Should be: Transparent
Independent
Accountable
Fair
Consistent
How ??
Role of MoH → Policy setting, commitment = important
Scientific process → international standards /
best practice = safety, quality & efficacy
Conflict of interest → important for good governance - legislate

8. Role of the Regulatory Authority
What ??
Public → guarantee safety, quality & efficacy of all medicines
Industry → guarantee certainty in terms of registration timelines/processes
Government → support access to medicines
~ timely availability
~ fast track registration
~ National Drug policy
- generic medicines
- mandatory generic substitution
~ educate patients/health professionals

9. What is an Effective & Efficient RA ?
Is defined by:
Scientific Principles Safety Quality Efficacy
Timely registration of medicines Timely availability of medicines Well resourced Open 2-way communication Transparent decision making Independence

10. 3. NAPM Concerns 2-stage registration process Intellectual Property
Expediting the registration of generics
Transition Phase / Period

11. 2-Tier Registration Process
Inefficient and Costly
An expensive scientific process could result at the end a completely wasted exercise
Safety, Quality and Efficacy does translate into public interest
Defies principles of transparency
Will create uncertainty for industry
Complicates registration process
- mixes scientific evaluation with broader issues covered elsewhere in legislation
Pricing within the PEEU
IP covered in the Patent Act
Industrial imperatives covered in Industrial Policy within DTi

12. Intellectual Property - Introduction
Access to affordable healthcare is a worldwide challenge
Generic medicines play a major role in facilitating access to
affordable medicines
Introduction & availability is dependent and influenced by the
patent term of the innovator, whose abuse or misuse can present a
barrier to entry
MTT (no generic representation on task team) recommended:
“It will be the responsibility of the industry applying for registration of its products to certify that it does not infringe IPR of the country.”
“Where the RA receives an application that contains confidential supporting information of an innovative product, the authority has the obligation to keep that information confidential, not to use that information to grant another license.”

13. Patent System in SA Current Patent Act Progressive TRIPS compliant
Protects public health - Supportive of DOHA declaration
Balance between innovation and access
Current Patent Filing System
Patents not examined or evaluated – granted as applied for
Open to abusive ever-greening practices
Generic companies respect valid patents, provided public benefits at
the end by full disclosure & ability to freely use invention once the
patent expires (wrt marketing not reg).

14. Intellectual Property and RA
Affidavit of patent non-infringement
contravention of section 69A of the Patents Act
~ allowed to develop, research but not make available for sale prior to patent expiry
~ How will the RA deal with non-patent infringing products introduced prior to patent expiry? This will delay introduction of a generic with huge cost implications for the country.
question of the validity of patents and/or patent infringement is the sole preserve of the Commissioner of Patents
sensitive to abusive ever-greening practices
Patent Term Extensions
Of no benefit to SA since R&D minimal to none & focus not on diseases of the poor
Clinical trials done out of convenience rather than investment need
Data Exclusivity
Not a requirement of TRIPS

15. NAPM Position on IP and RA
Regulatory delays affect both generics and originator medicines & will be addressed by restructuring of RA
IP = complex
~ will complicate registration process
~ will divert much needed resources away from core function of RA
~ will delay registration and entry of generic medicines
Generics industry unequivocally supports IPR for as long as the patent is in place and is valid but must allow immediate competition once patent expires
hence
IPR inclusion is unnecessary - RA cannot be held liable for “patent infringement” when their role is to assess safety, quality and efficacy
RA must stick to Scientific Principles - Safety, Efficacy and Quality

16. Expediting the registration of generics…. National Drug Policy
Why ??
promotes access to medicines
increases competition
How ??
Ensure timely availability of generics
Provide for fast track registration with strict timelines
Create a dedicated Office for Generic Medicines in the Authority
Support National Drug policy
~ encourage use of generic medicines → mandatory generic substitution
Educate patients/health professionals

17. Generic Lifecycle E X1 X2
R 78.00
R 65.00
R 52.00
R 39.00
R 26.00
SAVINGS D B A C D C Y
Further generic entry reduces price of generics and originator drugs
A reduction of up to 90% for the 250mg Ciprofloxacin
Originator price reduced as the effect of genericisation began to take effect.

18. Volume split between generics and originators (S3 –S7)
Ratio progression in volume terms bet originator & generic which is within a range of 35.3% up to 53.5 % evidences the significant volume growth for generics compared to that of originator & the relative pedestrian value growth for generics

19. Value split between generics and originators (S3 – S7)
Ethical = originator
MAT is the Moving Average Total from December of one year to December of the next year
TRD is the Trend in Percentage Rand
Ratio progression in value terms between originators & generics which is within a range of 22, 6% to 25% evidences the reasonably static growth of generic uptake in value terms.

20. Transition Phase from MCC to SAHPRA
Proposed changes = wide reaching - could lead to further registration delays if it is not managed appropriately
Management of transition phase/period = vital
Existing arrangements and commitments must be honoured
Registration queue is maintained
Pending registrations are completed
Consider phased approach
Set Time-lines for implementation
Adequate resources should be available and vacancies should be filled

21. 4. Conclusion
What needs to be done to facilitate restructuring process:
Bill must be clear
Bill must contain more detail
Non-core functions to be removed:
~ 2-step process must be removed
~ Intellectual Property (IP)
Must enable necessary regulations that give effect and support process

22. 5. Way forward Finalise Amendment Bill Enact necessary regulations
Direction on transition process

23. 6. Q & A
Thank you….