IAC, Melbourne, Room 203-204 Thursday 24 July, 14:30 – 16:00

Access to Innovation: Making Generic Versions of Newer Antiretrovirals Affordable

Focusing on middle income countriesLeena Menghaney, MSF Access Camapign

IAC, Melbourne, Room 203-204Thursday 24 July, 14:30 – 16:00

Organised by International AIDS Society

KKL, IAS, 2013, Andrew Hill

UTW, 17th Edition2014

UTW, 17th Edition2014

Issues in middle income countries

• World Bank classification of countries• Affected by TRIPS patent regime • Lack of transparency on prices being paid by

governments• Pressure not to use TRIPS flexibilities combined with

lack of political will • Left out of geographical scope of voluntary licenses • Lack of negotiation power/case by case basis• Very high prices in middle income countries. • Barriers to benefiting from generic competition

Use of TRIPS Flexibilities • Countries can send out clear message with a few CLs• Reserve IP incentive for new compounds i.e. active

ingredients that represent a fresh contribution to the stock of products available for medicinal use

• But not all patent applications relate to new compounds. Majority are for existing drugs (new use, new forms and new formulations)

• These can be rejected as such inventions that are common knowledge and practice in the pharmaceutical field

• Reduce the patent terms by addressing evergreening

First CL in India

Bayer Natco Pharma

0

50,000

100,000

150,000

200,000

250,000

300,000Rs. 2,80,428

8,880 6,840

Originator CompanyGeneric Companies

Rs.

/per

pati

en

t per

year

Cancer Drug-Sorafenib Tosylate 200 mg tablet

* The graph highlights the generic price of the cancer drug sorafenib tosylate. The drug is patented in India and Bayer's price is unafford-able. Natco has applied for a compulsory license to the Indian patent office in July 2011 and has committed to substantially reduce the prices by 97%(31 times) for cancer patients in India who need the drug if the compulsory license to produce the generic version is granted to the company by the Indian patent office.

Natco Pharma requested for a CL for the anti-cancer drug Nexavar (Sorafenib Tosylate), patented by Bayer

Not for drug supplied to the Public sector but actually sold in The private sector

Granted in March 2012:o Bayer’s import was grossly

inadequate to the needs (hardly 2%)o No import in certain yearso Price not reasonably affordable to

the public. Bayer price 5210 USD for 120 tabs for a month; Natco 164 USD

Generic competition or tiered pricingshort term gain – long term pain

1 2 30

50000000

100000000

150000000

200000000

250000000

300000000

10,000,000

45,000,000

250,000,000

Cost of new DAA

Tota

l Cos

t of T

reati

ng 5

0000

pati

ents

900$ 5000$

Generic competition

Recommendations

• Systematic Data collection on drug prices in middle income countries

• Highlighting the problem• Patent Reform in middle income countries (e.g. Argentina)• Challenging the geographical scope of VLs – using it as a

ground for a CL• Global Fund should continue supporting middle income

countries• Challenging the World Bank classification of countries as

not applicable to public health