International AIDS Activists meeting with generic Pharmas in Mumbai

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International AIDS Activists meeting with generic Pharmas in Mumbai

Joe

The US based The International Treatment Preparedness Summit/

Coalition. (ITPS) representatives are meeting with Indian generic

ARV producers in Mumbai on January 10th and 11th 2005. ITPS Act in

an advisory capacity to pharmaceutical companies, government

agencies, scientific researchers and other relevant bodies

Representatives of Ranbaxy, Cipla, Hetero and Strides are expected

to meet with the ITS delegates on January (10th and 11th).

As with the first World Community Advisory Board (CAB)meeting last

year in San Francisco, HIV I-Base a London based HIV AIDS activists

group is organizing the meetings on behalf of ITPC.

The ITPS delegations is consist of about 25-30 people, with 5-6

representatives from each region each region (i.e. Africa,

Asia/Pacific, Latin America/Caribbean, Eastern Europe/Former Soviet

Union and industrialized countries)

Although, no non ITPS delegates are invited to be part of the

delegation, it appears that if any of the Indian community groups

and agencies do have any pressing concerns, they wish to raise with

the Indian Generic ARV Pharma representatives, the ITPS team may be

willing to take up those issues with the industry.

DRAFT AGENDA

(As per the discussion taking place on the ITPS e FORUM this is a

tentative/ preliminary agenda).

1. INTRODUCTION and current status

a) Introduction from each company (product range and prices, current

distribution). (I'd also like to hear the process for each company

to

identify and formulate a drug).

Use of their drugs in India and Asia (this could also be in any

of

the other sections like Development and Future)

c) Status of the companies' re-application to the WHO's

prequalification project and bioequivalence testing more generally;

d) Whether they are applying to US FDA and what the process has

involved so far (how easy is the response, access to US pharma data

in application etc

e) Status of registration of products in least developed and middle

income countries;

f) Status of pricing policies (e.g. terms and conditions or Clinton

HIV/AIDS Initiative's negotiated price);

g) Experience/comment on country importation issues (tax etc)

h) Use of distributors who mark up drug prices

2. DEVELOPMENT - community identified needs

a) Need for paediatric formulations of ARVs and FDCs;

Pipeline generics: is there a timeline for tenofovir, nelfinavir,

ritonavir, kaletra, atazanavir etc. are there production

difficulties

that mean that some drugs will never be available as generics? Is

there a minimum timeline after FDA approval before a generic version

is considered? (ie non-refrigerated RTV);

c) Need for second-line regimens, in fixed-dose combinations;

d) Providing drugs for clinical studies;

e) Safety and monitoring issues: are side effects reported?

f) Side effects: reduced dose formulations of d4T;

3. POLICY - impact of ongoing global and national trade policies

a) Future use of compulsory licences and their marketing strategy in

a new IP legislative context in India;

Impact of the post Jan 1 2005 product patent regime in India

Registration bottlenecks in importing countries;

c) Joint ventures with R/D based pharma and the status of raw

material and patents;

4. OTHER

a) Other specific regional issues

References:

internationaltreatmentpreparedne

ss/

UK CAB

http://www.i-base.info/ukcab/index.html

First World CAB meeting report. 5-7 February 2004, San Francisco

http://www.i-base.info/wcab/index.html

HIV I base London

http://www.i-base.info/