HIV, Globilisation and Futures:HIV Clinical trials in a global world

Dr Gillian HalesRoche Products

HIV and the Futures of Globilisation

HIV and Globilisation are issues that relate to the individual and to the global community

Globilisation has led to increased information and expectations

The effect of Globilisation on Clinical trials & changes for the Pharmaceutical Industry

‘Developing Countries’ – An Umbrella Term

Tiers defined by economic status (World Bank)

Least Developed Countries (LDCs) e.g. Cambodia, Afghanistan, Haiti, Uganda

Defined by profound poverty & weakness of economic, institutional and human resources

Low Income Countriese.g. India, Indonesia, Vietnam

Lower Middle income CountriesChina, Philippines, Thailand

HIV and the Futures of Globilisation

Why should we undertake clinical trials in developing countries?

Broader demographics

Different clades

Large number of treatment naïve patients

HIV and the Futures of Globilisation

Ethical issues in clinical trials in developing countries

Ensuring that drugs post study are affordable

Ability for poor patients to provide informed consentif no other treatment options accessible

Different standards for trials in developing countries vs. high income countries e.g.:

Usage where contraindicated, e.g. breastfeeding

“Sub- standard” therapy

HIV and the Futures of Globilisation

What do clinical trials provide in developing countries?

Infrastructure

Education

Treatment

HIV-NAT

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),

HIV-NAT has completed 10 trials and is currently involved in conducting 12 additional trials in which approximately 1500 people are currently enrolled

Post-trial patients are receiving antiretroviral therapy at 17 sites throughout Thailand

The HIV Netherlands Australia Thailand research collaboration: lessons from 7 years of clinical researchKelly Safreed-Harmona, David A. Cooper, Joep M. A. Langec, Chris Duncomb, Praphan PhanuphakdAIDS 2004, 18:1971–1978

HIV-NAT

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),

HIV-NAT opened in 1996 with only one physician,

two nurses and two part-time laboratory staff members.

The organization now employs 40 people, including 6 physicians and 10 nurses.

The HIV Netherlands Australia Thailand research collaboration: lessons from 7 years of clinical researchKelly Safreed-Harmona, David A. Cooper, Joep M. A. Lange, Chris Duncomb, Praphan PhanuphakdAIDS 2004, 18:1971–1978

Eight Roche Policies Relevant to ‘Developing Countries’

Clinical trials (x2)1. All Roche drugs 2. HIV/AIDS specific

Patents (x2)

Pricing (x3)

Drug donations

Policy posted on http://www.roche.com

Aim of Policies

Provide clear and consistent parameters with guidance for action

A key part of Roche’s commitment to sustainability in action

Roche HIV drugs

Roche HIV Clinical Trials In

‘Developing Countries’

Covers Roche Sponsored Clinical StudiesANDRoche Supported Third Party Clinical Studies

Roche takes responsibility for issues relating to third party studies which it supports

Roche sponsored HIV studies

Continuous assured supply of Roche ARV for all participants after trial ends assured for as long as they continue to receive medical benefit from that medication, (provided that the benefit-risk ratio for the product continues to support such use)

Provisions for post trial care to be secured before the trial commences and clearly specified in patient consent forms

Description of post trial drug supply incorporated into the protocol

Support for third party sponsored HIV clinical trials in developing countries

SoC according to accepted standards of therapy as defined in WHO treatment guidelines for resource-limited settings or international treatment guidelines

A written agreement describing how post trial treatment will be assured for as long as participants continue to benefit from that treatment

Preference given to studies in developing countries which include centres in high income countries as well

Ethical standards demonstrably equivalent to those of a high income country

Commitment to publish information on a public Clinical Trials Registry

Roche Patent & Pricing Policies

Roche is committed to finding healthcare solutions that are sustainable and have a long-term impact, particularly on the lives of those living in the Least Developed Countries and sub-Saharan Africa

Roche aims to have a transparent patent and pricing policies for all its medicines in the world’s Least Developed Countries

Roche Patent Policy

Not to file patents for any medicines – across all disease areas – in the Least Developed Countries

Not to file patents on new or investigational HIV medicines in Least Developed Countries and sub-Saharan Africa

Not to take action in Least Developed Countries and sub-Saharan Africa against the sale or manufacture of generic versions of HIV medicines

No patents for its treatments for malaria – Fansidar® (sulfadoxine/pyrimethamine) or Lariam® (mefloquine) – in Least Developed Countries and sub-Saharan Africa

Roche Pricing Policies

HIV protease inhibitors (Invirase and Viracept) supplied at no profit to Least Developed Countries and sub-Saharan Africa (69% of all people living with HIV worldwide)

Roche no profit prices are 30-59% lower than the price of generic versions of these medicines

Reduced pricing for Invirase and Viracept available to low and lower middle income countries (+ 24% PLWHA)

Roche Drug Donations Policy

Drug donations not a key component of our policies to increase sustainable access to Roche medicines

Donating drug for chronic diseases is totally different to donating emergency aid

Pegasys for cryptosporidium in children (Africa)

Valcyte (Uganda)

Rocephin (Cambodia)

HIV therapy is lifelong; unethical for Roche donate ARVs without guarantee of lifelong continuous supply for each recipient

Regional commitment to HIV/AIDS

HIVNAT – Roche contribute to funding for HIVNAT

Cambodia Treatment Access Programme (CTAP)Cambodia currently has the highest recorded HIV prevalence in Asia, with over 170,000 people currently living with HIV/AIDS CTAP was established in September 2003 and is a three-way partnership between:

The Cambodian Ministry of Health The National Centre in HIV Epidemiology and Clinical Research (UNSW)Roche

The new treatment centre has been established to provide a range of clinical services and has been designed to provide the framework for a comprehensive programme of training and research in HIV medicine

Global commitment to HIV/AIDS

CARE ProgrammeThe Cohort programme to evaluate Access to antiretroviral (ARV) therapy and Education (CARE), which was set up by Roche and Pharm-Access International

The program aims to widen access to HIV therapy by focussing on disease education and building up local medical infrastructure

Roche provides the funding plus HIV treatment and diagnostic tests for the programme

Roche and HIV

Roche has a continued commitment to research and development in HIV/AIDS

Development of novel pharmaceuticals and diagnostic strategies to address key unmet medical needs, including an investment of US $800 million dollars to develop fusion inhibitors

Implementation of antiretroviral access programs in resource-poor settings

Establishment of collaborative partnerships to help build and strengthen healthcare infrastructures in these areas

Back-Up Slides

Roche Sponsored Clinical Trials in ‘Developing Countries’ - All drugs

Where continued treatment is necessarye.g. life-threatening diseases – cancerand no alternative treatment is available commercially,

an adequate supply of treatment is to be assured for all trial participants following the trial, until Roche drug available commercially

Provisions for post trial careto be secured before trial commences to be specified in patient consent forms

Roche Supported 3rd Party Clinical Trials in ‘Developing Countries’ - All drugs

The SoC according to accepted standards of therapy for the treatment of the disease as defined in WHO or international treatment guidelines

Preference given to studies in developing countries which include centres in high income countries as well

Ethical standards demonstrably equivalent to those of a high income country

Commitment to publish trial information on a public Clinical Trials Registry and results and outcomes on a public repository