[e-drug] Access to Medicine Index 2014 published

E-DRUG: Access to Medicine Index 2014 published
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[Interesting reading in this year's report.

All companies try to do something positive for access to medicines.

However I a very worried by the other finding that "18 of the 20 companies have been the subject of settlements or judgements regarding breaches in ethical marketing, bribery or corruption standards or competition laws in the last two years".

GSK seems to have been lucky that its record settlement of $488m for bribery in China was after the ATMIndex research period had closed...

Would be interesting to know if they had then still maintained first position if this was taken into account. WB]

Dear E-drug colleagues,

I'm pleased to inform you all that the Access to Medicine Index 2014 was launched today, Monday 17 November. It is now live on our website: www.accesstomedicineindex.org

Our hashtag is: #atmindex2014

I have included some key highlights from this year's report below, followed by more detail, and some findings from our analysis of R&D.

Following refinements made to our methodology in 2013, and a process of detailed expert review of our research in 2014, we believe this is the Foundation's clearest ever picture of the pharmaceutical industry’s strengths, weaknesses, progress and struggles regarding access to medicine.

GSK is in 1st place for the fourth time, ahead of Novo Nordisk (2nd) and Johnson & Johnson (3rd). The leading group comprises six companies in total, with close scores but different approaches to access to medicine. Some focus on a few specific diseases and target them with deep, comprehensive initiatives. Others adopt wide-ranging, integrated approaches. As a pack, companies are doing more to improve access to medicine, with companies at the bottom continuing to narrow the gap.

KEY FINDINGS

* Companies do more to improve access, but progress is uneven
The industry is progressing on several fronts. Regarding patents & licensing and public policy, however, the industry remains static.

* Five companies are developing more than half of pipeline products for developing countries
The top 20 pharmaceutical companies are developing 327 relevant products, with more than half of these products targeting the same five diseases.

* More than half of companies are developing medicines for children
7% of the overall pipeline is devoted to ‘child-size’ medicines, such as liquids, chewable tablets or new formulations.

* Pricing strategies are increasingly tailored
More companies are using commercial pricing strategies that also take socioeconomic factors into account.

WHO WE ARE

The Access to Medicine Index is an independent initiative that ranks the world’s leading pharmaceutical companies according to what they are doing for the millions of people in developing countries who do not have reliable access to safe, effective and affordable medicines and vaccines. It is published every two years.

DETAIL

THE 2014 RANKING

GSK tops the Index for the fourth time. This is driven by robust performance across most areas, with several innovative practices. It has an innovative business model focused on Africa, a large relevant portfolio, a large share of its pipeline dedicated to relevant diseases, and numerous access-oriented intellectual property sharing partnerships.

Novo Nordisk has made the most progress, improving in five of the seven areas the Index focuses on. This has resulted in a remarkable leap from 6th to 2nd place, which is partly due to the fact that its access activities are well managed, integrated into its business strategy, and well targeted to local needs. It also applies access-oriented pricing strategies to diabetes products in all Least Developed Countries. Eisai has risen steadily with each Index, and ranks 11th, up four places from 15th in 2012.

Sanofi and Pfizer fell down the rankings most significantly, while Astellas, Daiichi Sankyo and Takeda remain at the bottom of the league.

INDUSTRY PROGRESS

The industry has stepped up its efforts on several fronts. For instance, it is paying more attention to socioeconomic factors, such as people’s ability to pay, and increasingly tailoring prices within countries. Since 2012, the number of products in the pipeline appropriate for developing countries has grown by 47. More companies are experimenting with innovative access-oriented business models; three have introduced new models and three have expanded pilots. Companies are granting more licences to developing country companies to make and distribute generic versions of their medicines. Meanwhile, policies and activities to improve access to medicine continue to get better organised. All 20 companies now have some form of board-level representation for access-to-medicine issues, and the number of companies linking performance incentives to access to medicine has more than doubled since 2012.

PERFORMANCE WEAK IN TWO AREAS

However, progress is uneven across the areas of activity that matter, with the industry struggling to perform well in two important areas.

Firstly, nearly all companies (18) have been the subject of settlements or judgements regarding breaches in ethical marketing, bribery or corruption standards or competition laws in the last two years. During the period of analysis there were high-profile allegations of corrupt practices against several companies operating in China. The case against GSK, one of those companies, was settled after the period of analysis, and therefore did not affect its score in the 2014 Index.

Breaches captured in this Index range from paying or otherwise inappropriately incentivising doctors to prescribe their products, to collusions delaying market entry of generic medicines and misrepresenting the efficacy and safety of their products or those of their competitors.

The Index’s analysis reveals there is no direct correlation between a company’s size, the breadth of its geographical footprint and its incidence of breaches, which indicates that breaches are not simply a cost of doing business. This evidence raises questions over the commitment and effectiveness of company governance of this area.

Secondly, companies remain conservative in their public disclosure of where patents are active and when they will expire - information that is very useful to medicine procurers and generics manufacturers. Within the reporting period, no company independently and publicly disclosed patent statuses for products relevant to the Index.

RESEARCH AND DEVELOPMENT ANALYSIS

The 2014 Index reveals how concentrated the relevant R&D is. Just five companies are developing 54% of the 327 products in the pipeline. All disease classes are being targeted, but more than half of the products under development target just five diseases: lower respiratory infections, diabetes, hepatitis, HIV/AIDS and malaria.

About 36% of the pipeline targets non-communicable diseases, which are becoming increasingly important in developing countries. Encouragingly, 83% of these have reached the stage of development where they are being tested on people, but plans to make them available are limited. Pricing strategies for them are also limited, and lag behind those for many communicable diseases.

More than half of the companies are developing “child-size medicines, as liquids, chewable tablets, child-appropriate doses, or new formulations.

Research projects include an antifungal drug from Merck & Co. that is undergoing clinical trials to investigate whether it works for Chagas disease, a neglected tropical disease affecting South American countries; and GSK’s development of a low-cost inhaler for asthma and COPD drugs for use in developing countries.

Since the 2012 Index, at least 30 products from the pipeline, for 11 diseases relevant to developing countries, have come to the market. These include:

* A new type of pill for multi-drug resistant tuberculosis that is the first new drug for the disease in 40 years. (Johnson & Johnson)

* A new once-a-day pill that is a complete HIV treatment. Gilead has issued licences allowing distribution of generic versions of the drug in 100 developing countries.

* A new child-dose HIV tablet (Johnson & Johnson) and approval for an existing HIV drug to be given to children (Bristol-Myers Squibb). Almost all children with HIV live in sub-Saharan Africa.

* A ground-breaking pill that can cure hepatitis C, which is a high-burden disease in developing countries. The company has issued licences allowing distribution of generic versions of the drug in more than 91 developing countries. (Gilead)

We hope you find the 2014 Index useful in your work, and welcome reactions and views as we head into a round of methodology review in 2016.

Best,

Jay

Jayasree K Iyer (Mrs), PhD
Head of Research
Access to Medicine Index
Address: Scheepmakersdijk 5A, 2011 AS Haarlem, The Netherlands

E-DRUG: Access to Medicine Index 2014 published (2)
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I was very pleased to see that the Access to Medicines Index 2014 report came out on time.

While many people have jumped on the scores to see which company is up and which one is down, I would encourage E-Druggers to read the report by dipping into the different sections.
Pages 8 and 9 give you key messages with very short paragraphs.
The executive summary pages 10 to 19 provides a good overview and introduces the methodology.
For those interested in more detail about the methods used there is a detailed report at

http://www.accesstomedicineindex.org/sites/2015.atmindex.org/files/methodology_report_2013_for_the_2014_access_to_medicine_index_6.pdf .

The key findings are on Pages 22 to 25. Then there is a section on leaders, risers laggards and fallers. What strikes me is that there is no real pattern some big companies have done well and either gone up or stayed near the top others have fallen. Some risers are small companies others are big. Some like Novartis and Novo Nordisk were fallers and have returned up the ranking. Eisai is the leader of the Japanese and has been rising in each ranking.

Then from Page 49 to page 139 the seven technical areas are described in detail with many examples from both high and low companies in each section.

The section I found most interesting was on Pricing, manufacturing and Distribution. Here there were big risers with Bayer going from 12 to 4 and GSK falling from 2 to 7. Gilead remains number 1 in this section. In Patents and Licensing section Gilead is also number 1 with GSK on the same score 2.8 but Merck KGaA (the European Merck) has risen from 14 to 4 and Eisai from 17 to 5 which shows that big changes are possible.

The last part of the report from Pages 142 to 183 provides details of each of the 20 companies identifying the positives and negatives found in each company. Finally there are extensive appendices with detailed references and a section of definitions that is really a glossary.

In the class that I teach at Boston University on Analyzing Pharmaceutical Systems I have had the class review the previous 2012 report and I plan to have next year's class review this edition. It is a good way to learn about how different each of the Pharma companies are. They are often lumped together as Big Pharma but in reality each company is unique and understanding how different each is will help improve understanding and communication. Also there are many different ways to improve access to medicines.

There have been quite a few newspaper stories about the index. They are available at
- REUTERS http://www.reuters.com/article/2014/11/17/us-health-medicines-access-idUSKCN0J100B20141117

- Financial Times http://www.ft.com/intl/cms/s/0/52e8ccde-6cb2-11e4-b125-00144feabdc0.html#axzz3JInbaR7J

- The Guardian http://www.theguardian.com/business/2014/nov/17/gsk-top-table-for-drugs-access-developing-coountries
- Die WELT http://goo.gl/21aqyc
- Die Welt second article http://goo.gl/5dLCF

- India Times http://economictimes.indiatimes.com/news/international/business/corruption-tars-drug-industry-drive-to-improve-access-for-poor-glaxosmithkline-retains-top-spot/articleshow/45172403.cms

- NRCQ Online http://www.nrcq.nl/2014/11/17/medicijnen-worden-steeds-toegankelijker-maar-nog-niet-voor-iedereen

- PHARMATIMES http://www.pharmatimes.com/Article/14-11-17/GSK_and_Novo_top_access_to_meds_table_for_poor.aspx?utm_source=dlvr.it&utm_medium=twitter
- BIZNEWS http://www.biznews.com/health/2014/11/17/drug-industry-corruption-18-top-20-companies-breached-ethical-standards/

- Volkskrant http://www.volkskrant.nl/economie/farmaceutische-industrie-ontdekt-de-derde-wereld-als-afzetmarkt~a3791723/
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- NOS http://nos.nl/artikel/722277-farmareuzen-in-touw-voor-3e-wereld.html

I am sure there will be more,

Whenever someone asks me about the Index, I always say look behind the numbers, read the text and that is what I encourage E-Druggers to do,

Richard Laing
Professor International Health
Boston University School of Public Health,
801 Massachusetts Avenue Boston MA 02118
Tel 617 414 1445 (Office) 617 435 7860 (Mobile)
http://www.bu.edu/pharm/the-program/
E mail richardl@bu.edu

E-DRUG: Access to Medicine Index 2014 published (4)
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Like Richard Laing I read the latest version of the Access to Medicine Index with interest and also like him I'm interested in looking beyond the numbers. In my case I'm looking at what is not measured. Here are some of the things:

1. Instead of just looking at the number of products being developed for developing countries it would be at least as useful to look at how much of the total R&D budget is going into those products.

2. In setting pricing policies do companies include middle income countries or just limit themselves to low income countries?

3. Do companies (or their subsidiaries) market useless, dangerous products or products that have been withdrawn in developed countries and what percent of their portfolio do these drugs account for?

4. How do company marketing codes compare to the WHO Ethical Criteria?

Joel Lexchin
--
Joel Lexchin MD
Professor
School of Health Policy and Management
Faculty of Health
York University
4700 Keele St.
Toronto ON
Canada M3J 1P3
Tel: +416-736-2100 x 22119
Fax: +416-736-5227
E mail: jlexchin@yorku.ca