[Ip-health] Access to Medicine Index 2016 - Published today

Danny Edwards dedwards at atmindex.org
Mon Nov 14 01:27:59 PST 2016

Dear IP-health colleagues,

I'm emailing to inform you all that the Access to Medicine Index 2016 was launched today, Monday 14 November.  It is now live on our website: www.accesstomedicineindex.org.  
It is the result of two years of methodology review, stakeholder input, company input, data collection, analysis and writing.  Thanks to all those who contributed to this.
I’ve included a high-level summary of the Index in this mailing, and some of the headline key findings for this report, with a bit more in depth in IP findings.   I’m happy to respond to any questions.
GSK, leading the Index for the fifth time, performs best when it comes to matching its access activities with externally identified needs.
GSK is joined at the top of the Index by a closely packed group comprising Johnson & Johnson, Novartis and Merck KGaA. The pharmaceutical industry is extremely diverse, and this is reflected in the way each company approaches access to medicine. However, the four companies in this leadership group share some distinguishing characteristics. They have the most mature access programmes, with well-organised access strategies that support business development in emerging markets, where the need for access to medicine is high. They also show the most evidence of addressing independently identified high-priority needs.
The companies that rose most significantly up the Index were AstraZeneca and Takeda, which both extensively expanded and updated their access strategies. AstraZeneca climbed eight positions into the top 10 to take 7th position, while Takeda moved up five places to rank 15th. Novo Nordisk, Roche and Gilead have experienced the most significant drops in ranking, after being outperformed by peers.

The 2016 Index has assessed the extent to which a company’s access operations are needs-oriented: where actions match specific priorities identified by, for instance, countries, the global health community or the Index. In this regard, the Index analysis reveals uneven performance.
The companies have 850 products on the market for the 51 most burdensome diseases in low- and middle-income countries, and are developing another 420. This includes more than 100 products that have entered the pipeline since 2014 and 151 with low commercial incentive but which are urgently needed, mainly by the poor.
The diseases getting the most attention from company access activities are heart disease, lower respiratory infections and HIV/AIDS. R&D is still concentrated on five diseases, with lower respiratory infections getting the most focus, followed by diabetes, malaria, viral hepatitis and HIV/AIDS.

The same three companies lead in Patents & Licensing as in 2014. All three have pulled ahead from the pack, with Gilead and GSK extending their lead over Bristol-Myers Squibb.

Since 2014, seven companies have published new or expanded pledges to waive or abandon patent rights in certain countries or regions. A total of 16 now have such pledges (13 of these are publicly available). These vary in breadth and scope, with some covering more countries and regions, and some focused on only one product.

Three companies now voluntarily self-disclose of their patent portfolios, which supports the supply of generic medicines. This compares with none doing so in 2014 (outside of those who disclose via MedsPal @ the Medicines Patent Pool)

In a change from 2014, licensing is now being applied to products for hepatitis C, as well as for HIV/AIDS. Five companies in scope are marketing new-generation hepatitis C products: AbbVie, Bristol-Myers Squibb, Gilead, Johnson & Johnson and Merck & Co., Inc. Bristol-Myers Squibb has agreed to license daclatasvir (Daklinza.) and Gilead has agreed to license sofosbuvir (Sovaldi.) sofosbuvir/ledipasvir (Harvoni.) and sofosbuvir/ledipasvir/velpatasvir (Epclusa.) respectively. These products (except for Epclusa.) are on the WHO Model EML. Licensing need not be limited to HIV/AIDS and hepatitis C. Companies should now view licensing as an important tool for efficiently deploying products for many diseases, particularly in high-volume markets. GSK has signalled that it is open to licensing its entire patented portfolio, including future oncology products. AstraZeneca has also signalled a readiness to license its products, but has excluded products for non-communicable diseases, which account for most of its patented portfolio.

While companies succeed in including some MICs with high inequity in the scopes of their licences, they leave other such MICs out. For hepatitis C products: Armenia, Brazil, China, Colombia, Mexico, Moldova, Kosovo, Peru, Tajikistan, Thailand and Ukraine are not covered by licences. These countries are home to 22.4 million people living with hepatitis C."
The Index examines 22 diseases and conditions for which the G-FINDER tool from Policy Cures has identified a need for new products with limited commercial incentive. Companies are addressing 18 of these diseases, with most activity focusing on malaria, HIV/AIDS and tuberculosis, followed by viral hepatitis. Activity in this area is concentrated among a handful of companies. A core group of six account for nearly three-quarters of the 151 high-priority, low-incentive products in development. GSK is developing the most, with 32 projects in the pipeline, followed by AbbVie, with 19 projects, and Johnson & Johnson with 17. Meanwhile, four of these companies devote more than 50% of their relevant pipelines to high-priority, low-incentive product gaps.
The majority (67%) of the research projects that companies have for high-priority, low-incentive products are being conducted in partnerships. 
Some diseases that urgently need products, such as soil-transmitted helminthi- asis, have very few R&D projects targeting them, while others, such as Buruli ulcer, trachoma, cysticercosis and syphilis, have none. Some diarrhoeal diseases are 
being addressed, but not cholera, giardiasis or particular intestinal E. coli infections even though they have all been identi ed as needing attention.
A product can only be made available in a country once it has been registered there. The Index finds that, for their newest products, companies apply for registration in only 25% of countries the Index identifies as the highest priority. 

The Index finds that pricing schemes that take account of the ability to pay are being applied to one-third of relevant products. This has not changed since the last Index two years ago. Only 5 % of products (44 out of 850) have such pricing strategies applied in countries the Index identifies as the highest-priority, with at least one socio-economic factor being taken into account. Around half of these products are from GSK and AstraZeneca.
We’ve been looking at this for 10 years now, and the thing that stands out is how diverse the industry is.  This diversity shows a variety of different ways in how companies approach access - and this allows us to see what works, and what doesn't work so well. In this way, we find sharing practices which stand out (referred to as best practices in the report) and unique-in-industry practices (referred to as innovative practices) helps the companies to learn from each-others work.

Hashtag is #atmi2016

All the best,

Danny Edwards
Research Programme Manager
Access to Medicine Foundation

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