wec-ief panel on community engagement washington, 12 th of may, 2005 boehringer ingelheim’s...

WEC-IEF Panel on Community EngagementWashington, 12th of May, 2005

Boehringer Ingelheim’s Viramune® Donation Programme

Boehringer Ingelheim GmbH

Dr. Hartmut Leidig

Dr. Hartmut Leidig, Boehringer Ingelheim WEC-IEF Panel, Washington, 12 May 2005 2

BI’s Viramune® Donation ProgrammeOutline of the presentation

1. C(S)R1) /Sustainability in pharmaceutical industry sector

2. PPP2) - and C(S)R-programmes of pharmaceutical companies

3. HIV/AIDS-pandemia4. The “lost continent” Africa (?)5. Boehringer Ingelheim in Brief6. Boehringer Ingelheim’s ARV3) - Drugs7. Boehringer Ingelheim’s Viramune® Donation

Programme8. Further activities of BI in fighting against HIV/AIDS9. Conclusion

1) C(S)R: Corporate (Social) Responsibility2) PPP: Public Private Partnership3) ARV: Antiretroviral


BI’s Viramune® Donation ProgrammeC(S)R/Sustainability in pharmaceutical industry sector I

Results of the CSM1)/WWF Research Project (2003):“The Business Case for Sustainability-Pharmaceutical Industry sector report” 2) Industry’s C(S)R/Sustainability-Impact

Social dimension- Large impact on stakeholders and society as a whole

Environmental dimension- Low to moderate impact on stakeholders and society as a

whole Industry’s level of achievement

Social dimension- Achievements in terms of stakeholder needs low to

moderateEnvironmental dimension

- Achievements in terms of stakeholder needs relatively high

1) Forum for Corporate Sustainability Management at Int. Institute for Management Development (IMD), Lausanne, Switzerland

2) Participation of 15 global PharmaCos and 15 stakeholder institutions


BI’s Viramune® Donation ProgrammeC(S)R/Sustainability in pharmaceutical industry sector II

Results of the CSM/WWF Research Project (2003):

Major C(S)R/Sustainability issues

- Access to healthcare (esp. in the developing world)

- R&D expenditure (“civilization” diseases versus infectious diseases)

- Intellectual Property, Patent Protection and TRIPS 1)

- Health economics in the developed world

1) TRIPS: Trade-Related Aspects of Intellectual Property Rights


BI’s Viramune® Donation ProgrammePPP and C(S)R-Programmes of pharmaceutical industry I

A few examples: Reduction of child mortality

- Donation Programme for Prevention of Mother to Child Transmission of HIV1 (Abbott, Boehringer Ingelheim)

- Donation of 30 Mio Polio-vaccinations in 16 African countries(Sanofi-Aventis)

- Secure the Future AIDS/HIV Project(BMS)

- 1500 Programmes in 80 countries against vitamin A deficiency in small children (Hoffmann La Roche)

- Vitamin A Programme for 250.000 Indian children to avoid blindness (J&J)


BI’s Viramune® Donation ProgrammePPP and C(S)R-Programmes of pharmaceutical industry II

Fight against infectious diseases (HIV/AIDS, malaria, tuberculosis, etc)- Accelerating Access Initiative for AVR-drugs

(Abbott, Boehringer Ingelheim, BMS, Gilead, GSK, Hoffmann La Roche, Merck & Co)

- Several large anti-malaria programmes(inter alia Sanofi-Aventis, Novartis, GSK)

- Tuberculosis-Programmes in East Europe, India, Africa(Astra Zeneca, Novartis)

- 16 Mio antibiotic treatments in 11 countries for prevention of river blindness (Pfizer)

- Programmes against sleeping disease(Sanofi-Aventis, Bayer)


BI’s Viramune® Donation ProgrammeFacts on HIV/AIDS-Pandemia

Today: > 40 Mill humans infected with HIVthereof ~ 25 Mill in Sub-Saharan Africa

Until 2015: ~ 80 Mill deaths on AIDS estimated in Africa

Currently most of new infections are in women in childbearing age

In some African countries the sexual active generation (15 – 45 years) is currently largely infected and will “die out”

AIDS in Africa is only one disease amongst others (malaria, tuberculosis, sleeping sickness, etc)


BI’s Viramune® Donation Programme Reasons for HIV/AIDS-Pandemia

Vicious Circle of Poverty and Illness:Illness is the main cause for poverty!Poverty is the main cause for illness!

Poverty leads to a loss of all human rights:- right of health care- right of adequate food- right of education- right of justice

Other Reasons: Lack of sex educationLack of informationPolygamyCultural taboosPolitical/social ignorance & disavowal

Poverty Illness


BI’s Viramune® Donation Programme Fighting against HIV/AIDS-Pandemia I

• “HIV/AIDS is no longer

simply a public health crisis

in the developing world - it

is a major development

issue”

• a multisectorial response

is required involving

public-private

partnerships

Kofi Annan - December 1999


BI’s Viramune® Donation Programme Fighting against HIV/AIDS-Pandemia II 2003: WHO announced 3 by 5 initiative

i.e. Medical treatment for 3 Mill AIDS patients in 2005

Sep. 2004: ART1) for ~ 333.000 AIDS-patients through

AAI2) of pharmaceutical companies

Global Fund to Fight AIDS, Tuberculosis & Malaria (GFATM)

US President’s Emergency Plan for HIV/AIDS Relief (PEPFAR)

Bill Gates foundation

1) ART: Anti-retroviral therapy2) AAI: Accelerating Access Initiative


BI’s Viramune® Donation ProgrammeThe “Lost Continent” Africa (?) View from the outside

Sub-Saharan Africa is facing its most serious crisis in history!

Perception of Europeans about Africa:

- Incapable of “modern” development

- “Tribe wars” on the scene

- Stop of democratic development in many countries

- Violence and brutality everywhere

- Corrupt regimes

But: Keep in mind the Balkans war (ex-Yugoslavia) in the 1990’s!


BI’s Viramune® Donation ProgrammeThe “Lost Continent” Africa (?) Challenges & Parallels to European history IThere are 4 challenges or rather 4 processes to

undergo:

1. Challenge/process: PANDEMIAAfrica: AIDS (tip of the iceberg) – Malaria – TuberculosisEuropean Parallel: ‘The Plague’ – middle of the 14th century

> collapse of all social, economic, political systems

> Europe was a “valley of misery”

2. Challenge/process: DECLINE of AUTHORITY of the STATEAfrica: Somalia, Ruanda, Congo, Liberia

> Corrupt regimes, war lords, vacuum of powerEuropean Parallel: “The Thirty years war” in Middle Europe in the 17th century

> horror, cruelties, brutality > “Swedish drink” – “To tar and

feather”


BI’s Viramune® Donation ProgrammeThe “Lost Continent” Africa (?) Challenges & Parallels to European history II3. Challenge/process: NATION BUILDING

Africa: Eritrea, Congo, Somalia, Suda > nations were build arbitrarily at the end of

colonial period without considering ethnicities and culturesEuropean Parallel: Current European nations are built in 19th/20th Century > Bismarck: “Nations are forged out of blood and iron!”

4. Challenge/process: GLOBALISATIONAfrica: African countries are faced with globalization although being at

the brink of world economyEuropean Parallel: Globalization is the social & economic challenge of the 21st century


BI’s Viramune® Donation ProgrammeThe “Lost Continent” Africa (?) Challenges & Parallels to European history III

What makes the difference between EUROPE and AFRICA in

managing these 4 Challenges/Processes?

EUROPE had 800 years to manage them.

AFRICA has to manage all of them at once!


BI’s Viramune® Donation ProgrammeThe “Lost Continent” Africa (?) - Prospects

There is a future for this continent!

Because > Africa is not dominated from outside anymore

> Fortunately there is no/little interest of “super powers” in

Africa

> Realization of African problems and problem solutions is growing

> some African leaders opt for “African Renaissance”

But > There is no quick rebirth

> There is no rescue from outside

(at least support of global community)


BI’s Viramune® Donation ProgrammeThe “Lost Continent” Africa (?) – Encouraging Example

Developed World

Miss ‘World’

Beauty contest

Luxury

‘haute couture’

Botswana (Africa)

Miss “Stigma Free 2005”(Miss HIV)

Not only beauty but HIV-coming out on stage

Breaking taboo of HIV-infection

FORMULA: ‘Education & Entertainment’

The ‘Catwalk’


BI’s Viramune® Donation ProgrammeBoehringer Ingelheim in Brief (I)

Focus on Human Pharmaceuticals and Animal Health

Operating worldwide (152 affiliated companies)Research-drivenFounded in Ingelheim, Germany in 1885Family-ownedApprox. 36,000 employeesNet sales 2004

Total: EUR 8,157 millionBy region: Americas: 48%

Europe: 32%AAA:* 20%

BI rank: 15. by sales (among leading Pharma Cos)

* Asia, Australasia, Africa


BI’s Viramune® Donation ProgrammeBoehringer Ingelheim in Brief (II)

BI’s business areasHuman Pharmaceuticals (96% of net sales)

- Prescription Medicines (76% of net sales)

- Consumer Health Care (12% of net sales)

- Industrial Customers (8% of net sales)(Fine Chemicals, Biopharmaceuticals)

Animal Health (4% of net sales)

Top 10 products Branded Prescription Medicines

Flomax ® - Mobic® - Micardis® - Spiriva® - Combivent® -

Sifrol® - Viramune® - Atrovent® - Catapresan® - Mucosolvan®


BI’s Viramune® Donation ProgrammeBoehringer Ingelheim’s ARV 1) - Drugs Viramune®

INN2) : Nevirapine- 1. non-nucleoside reverse transcriptase inhibitor

(NNRTI)- Market introduction 1997/1998

Aptivus®INN2) : Tipranavir

- Non-peptidic protease inhibitor (NPPI)- Activity against HIV that is resistant to other

commercially available protease inhibitors- Submission of Marketing Authorisation Application to

European and US-health authorities: October 2004

1) Antiretroviral2) International non-proprietary name


BI’s Viramune® Donation ProgrammeWorldwide children HIV Infections 2004

A Crushing Choice for Ethiopian Mothers with HIV

The Washington Post, Feb 19, 2005

Adobe Acrobat Document


BI’s Viramune® Donation ProgrammePMTCT - Definition

Since July 2000 Boehringer Ingelheim has provided

VIRAMUNE®

free-of-charge to developing countries

for the Prevention of Mother to Child Transmission of HIV- 1

(PMTCT)

(Programme adheres to WHO Donation Guidelines)Over 120 countries are eligible worldwide(as defined by the World Bank list)

Eligible countries


BI’s Viramune® Donation ProgrammePMTCT - Who is Who?

Facilitator:

BI works with Axios International, which is world leader in providing health care services in developing world, particularly PMTCT.

Axios …provides evaluation and support for applicants…discusses and evaluates the quantities of drugs needed…facilitates communication between BI and MTCT programmes…sensitizes the programmes on the need to address the issues of import, storage and distribution of VIRAMUNE…ensures appropriate dispensing and use of the drug…assists some programmes to improve the programme design or put them

in contact with institutions that can help


BI’s Viramune® Donation ProgrammePMTCT - Access the donation

The Application

Online at

www.pmtctdonations.

org

- ask questions

- download and submit application form

- check progress of Donation Programme

Direct Contact Axios

Axios7, bd de la

Madeleine 75001 Paris, France

Phone: +33 144 860 760

Fax:+33 144 860 122

E-mail: [email protected]


BI’s Viramune® Donation ProgrammePMTCT - A catalyst for inter-company cooperation

Abbott Laboratories donates the “Determine® rapid HIV test kit” free of charge for use in PMTCT

BI and Abbott cooperate to reduce burden on applicants

- common application form www.pmtctdonations.org

- common information outreach Baxa donates syringes for use within the

Viramune® Donation Programme

- BI confirmed 2 months stability of the Viramune

- Baxa syringes are part of the shipments


BI’s Viramune® Donation ProgrammePMTCT - Progress

Number of applications is constantly increasing

- 125 programmes in 57 countries included in the VIRAMUNE® Donation Programme

- Viramune provided to reach ~461,000 mother-child pairs


BI’s Viramune® Donation ProgrammePMTCT - VIRAMUNE provided for mother-child pairs

0

50000

100000

150000

200000

250000

300000

350000

400000

450000

Q2-2001

Q3- Q4- Q1-2002

Q2 Q3 Q4 Q1-2003

Q2 Q3 Q4 Q1-2004

Q2 Q3 Q4

MC Pairs


BI’s Viramune® Donation ProgrammePMTCT - Participating Countries


BI’s Viramune® Donation ProgrammePMTCT - Challenges

Drug component is a relatively small part of the financial and human resources required for a comprehensive MTCT prevention programme

The challenges are:

- community education and awareness of HIV and MTCT

- programme management

- training of medical staff

- HIV testing

- voluntary counseling

- antenatal and postnatal care


BI’s Viramune® Donation ProgrammePMTCT - Opportunities

As the price of nevirapine is not a barrier

Availability of nevirapine is, in itself, a catalyst for the investment and development of health care infrastructure

- increased willingness of HIV+ and HIV- mothers to participate in the health care system

VIRAMUNE® Donation Programme is a partnership

- capturing important information about PMTCT programmes that will be provided back to the community


BI’s Viramune® Donation ProgrammeFurther activities of BI in fighting HIV/AIDS

Accelerating Access Initiative (AAI)Cooperation of 7 globally

operating pharmaceutical

companies have significantly

reduced the prices for their

respective antiretroviral drug.

Joint materiales e.g. press releases

Number of HIV patients in the developing world

receiving antiretroviral treatments provided by AAI

companies reached > 333,000 (Sep 2004). This is ~ 50% of all chronic

treatments

BI is one of the 5 founder partners of the AAI in 2000!


BI’s Viramune® Donation ProgrammeAccelerating Access Initiative


BI’s Viramune® Donation ProgrammeFurther Activities of BI in fighting against HIV/AIDS

VOLUNTARY LICENSESBI as patent holder signs agreement with generic companies to allow production of generic nevirapine alone or in combination under certain pre defined conditions

Current status:

- Aspen Pharmacare (SA)

- Thembalami (SA)

- CIPLA Medpro (SA)

- Memphis (Egypt)

- Cosmos (Kenya)

Export to 47 sub saharian

countriesExport to Egypt and COMESA countriesExport to

Uganda and Zimbabwe


BI’s Viramune® Donation ProgrammeConclusion

Are these PPPs and Programmes

C(S)R/Sustainability business cases for the pharmaceutical industry

or mere charities?

They are C(S)R/Sustainability business cases

as

they are increasing the value of a company and they support the sustainable development of a

company!


BI’s Viramune® Donation Programme

Inaugural Adress of Franklin D. Roosevelt (January 20, 1937)

“….The test of our progress is not whether we add more to the abundance of those who have much;it is whether we provide enough for those who have too little….”

Thank you for your attention!

Questions?

Comments?

wec-ief panel on community engagement washington, 12 th of may, 2005 boehringer ingelheim’s...

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