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