[e-drug] Access to Medicine Index 2016 - Published today

e-drug
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E-DRUG: Access to Medicine Index 2016 - Published today
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[It would be good to see responses to this information from E-druggers. BS]

Dear E-drug 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. Over the coming days I will go into a little more depth on each of the findings via e-drug, and am looking forward to your responses. As with your work, our insights also work when they are they are shared and discussed by people working in global health. I am happy to respond to any questions about our findings.

RANKING
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.

OVERALL
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 and 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 and AIDS.

R&D
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 and 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 identifed as needing attention.

PATENTS & LICENSING
Movement is seen in the way some companies are handling their patents and in the extent to which they are allowing other manufacturers to make generic versions of their products. Seven companies have published new or expanded pledges to waive or abandon patent rights for certain products in certain regions. More HIV/AIDS products are covered by voluntary licenses and these apply in more countries than they did before. And for the first time, voluntary licensing is being used to expand access to medicines for a disease other than HIV and AIDS and hepatitis C. However, middle-income countries outside of sub-Saharn Africa more likely to be left out of licensing agreements. There are new commitments from companies to consider licensing outside of these HIV/AIDS and hepatitis C - pointing the way to broader use of voluntary licensing in the future. Three companies have now self-disclosed patent statuses, but the nature of the disclosure is not consistent.

PRICING & REGISTRATION
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 have 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
www.atmindex.org
Danny Edwards <dedwards@atmindex.org>

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E-DRUG: Access to Medicine Index 2016 - Published today (2)
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Here are a some items that the ATM index does not measure:

1. What percent of a company's R&D budget is going to drugs for Type II and Type III diseases. Rather than give the number of projects the percent of the R&D budget would be a much more meaningful measure;

2. How many dangerous/irrational/withdrawn drugs are companies selling in LMICs?

3. Not being found to have been the subject of settlements for breaches of criminal or civil laws or regulations relating to corruption or unethical marketing
anywhere in the world is a pretty low bar considering how difficult and long it takes to be found guilty in many places in the world.

How about how much money per doctor is spent on promotion in LMICs? How about comparing companies marketing codes to the WHO Ethical Criteria.

Joel Lexchin
--
Joel Lexchin MD
121 Walmer Rd.
Toronto ON
Canada M5R 2X8
E mail: joel.lexchin@utoronto.ca

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E-DRUG: Access to Medicine Index Report 2016 - (3)
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The report failed to acknowledge companies' pressure on countries to stop them from using the TRIPS flexibilities they are entitled to use - such as the Novartis pressure on Colombia to stop issuing compulsory license on imatinib ('Glivec') which is highly priced by Novartis and thus unaffordable to patients or govt.

Also, donating medicines should not be a criterion for a good company. There are loads being written, including in this list, about the problems of in kind donation of medicines. For a start it is not a sustainable way of providing access to medicines.

Mohga Kamal-Yanni
Senior health & HIV policy advisor, Oxfam GB
Editor of www.globalhealthcheck.org
John Smith Drive, Oxford, OX4 2JY, UK
Mohga Kamal-Yanni <mkamalyanni@Oxfam.org.uk>

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E-DRUG: Access to Medicine Index Report 2016 - (4)
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Dear e-drug list members,

I waited a few days to allow some comments and questions to come in on the 2016 Index, so I could respond in one go. Thanks for the interest shown. Our reflections follow:

@ Joel <<What percent of a company's R&D budget is going to drugs for Type II and Type III diseases. Rather than give the number of projects the percent of the R&D budget would be a much more meaningful measure>>

We measure the proportion of a company's R&D investments that are dedicated to diseases within the scope of the Index. The companies are scored on this, it has an impact on their overall performance in the Index, and it is described - for notable companies - in their report cards. We also think it’s important to look at how each project is likely to be supportive of access: e.g. projects aimed at developing innovating medicines versus adaptations specifically directed at LMICs; projects targeting high priority product gaps that offer low commercial incentives; whether or not projects have plans for access in place (registration, equitable pricing, licensing plans, for example). The 51 diseases and conditions included in the Index include (but are not limited to) type II and III diseases, as we also capture R&D for non-communicable diseases which have the highest burden in LMICs. At the moment, the most up-to-date classification of diseases by type I/II/III available is from 2012.

@ Joel << How many dangerous/irrational/withdrawn drugs are companies selling in LMICs?>>

This is a good point, and is a challenging aspect to measure. On a product level we’d need registration information on a per country basis, and corresponding up-to-date pharmacovigilance information per product, and then establish country-by-country which products were on-sale in the LMICs within our country scope. As a way of addressing this challenge, we approach this data gap in a couple of ways:

We look at the degree to which companies are involved in ensuring rational use of their products in country, by adapting brochure and packaging information to ensure that healthcare professionals prescribe products appropriately, understand how to use them, and also to ensure that patients themselves know how to use them.

We also measure the degree to which companies are proactive around pharmacovigilance (especially going beyond legal/regulatory requirements), and whether or not they have procedures in place which allow for the efficient updating of product labels in low income countries (this was a new measure for 2016) in response to changing information about product safety data elsewhere (pages 55,56,58).

We also expect companies to commit to WHO GMP guidelines for product recalls, and ask companies to disclose product recalls over the previous two years, checking these against external sources, and look at how companies manage the effective operation of product recalls in LMICS (page 36).

Also, to an extent the sale of sub-standard products/misrepresentation of efficacy is captured under the ethical marketing sub theme, as individual cases of reported breaches of codes of conduct, regulations and laws (overstating/misrepresenting the efficacy of products, failing to disclose known risks/side effects.) The limitations of relying on regulatory and reporting structures in lower income countries however means we aren't able to get a granular picture solely on the basis of breaches in these regions.

@ Joel <<Not being found to have been the subject of settlements for breaches of criminal or civil laws or regulations relating to corruption or unethical marketing anywhere in the world is a pretty low bar considering how difficult and long it takes to be found guilty in many places in the world. >>

This is an important point. This is why we place no time limit on the breaches/settlements/judgements we include for analysis. They can be historic in nature, but need to be settled (and not appealed) during the 2 year period of analysis. We also take breaches into account even if they occur in HICs, rather than focusing only on LMICs, where they might be less likely to be prosecuted, or identified and reported. However, we don’t include cases which are currently in the courts/or allegations/or judgements under appeal for the simple reason that we do not have all the evidence regarding each case, and in order to be even-handed, we need to wait for a judgement to be made by an appropriate regulatory/judicial body. If the ruling is found against the company, then we include it. On page 51, we report that “a total of 51 settlements were identified by the Index (…) The overall number of breaches has dropped since 2014: from 73 to 51. Independent research suggests that this does not necessarily indicate an improvement in conduct and may also be due to [factors related to] judicial and regulatory systems.

@ Joel <<How about how much money per doctor is spent on promotion in LMICs?>>

This is another area where availability of data (public or otherwise) makes measurement challenging. As you know there have been movements towards greater transparency in this regard in the US and the EU, but in low and middle income countries (in general) this information is less available. We ask for companies to disclose this information to us (a first step before being able to stratify good practice from poor) and in general the level of information provided is low. We agree that transparency in the area can be improved. This is discussed and highlighted on page 52 of the 2016 report. Something interesting to consider for the future would be highlighting those companies who place a blanket ban on such inducements.

@ Joel <<How about comparing companies marketing codes to the WHO Ethical Criteria>>

This is a good point, and a comparison was carried out during the 2015 methodology review between the WHO Criteria and the IFPMA code. We thought it would be clearer if we identified key differences between the two, and asked companies whether or not they had policies in place which reflected the more stringent criterion. One key difference between the IFPMA code and the WHO Criteria is how sales staff are incentivised by companies. (from the WHO Criteria: “…In order to avoid over-promotion, the main part of remuneration of medical representatives should not be directly related to the volume of sales they generate.”) this measure was included in the 2016 Index, and is called out on page 51. As noted above, and considering other differences between the IFPMA Code and the WHO Criteria, perhaps identifying companies who place a out-right ban on inducements is a next step. I’d be interested in the point of view of others on this (or on other stringencies that could be considered) as part of the 2017 methodology review.

@ Mohga <<The report failed to acknowledge companies' pressure on countries to stop them from using the TRIPS flexibilities they are entitled to use - such as the Novartis pressure on Colombia to stop issuing compulsory license on imatinib ('Glivec') which is highly priced by Novartis and thus unaffordable to patients or govt.>>

This is an ongoing issue which we continue to measure and score companies on, and is discussed on page 28 of the report. The extent of lobbying that goes on (which to a large extent is informal) is hard to identify, but concrete examples which were included in scoring and analysis are (for eg.) lobbying which took place in SA Gov over AGOA, in India over recent IP reform processes, and during the TPP negotiations. Colombia was on the radar too.

@ Mohga <<Also, donating medicines should not be a criterion for a good company. There are loads being written, including in this list, about the problems of in kind donation of medicines. For a start it is not a sustainable way of providing access to medicines.>>

We also acknowledge this in the report that donations are likely to be appropriate only in very specific circumstances, and highlight the fact that it is crucial that companies consider the long-term sustainability of improvements in access to medicines – particularly where life-long treatment is needed – beyond the duration of these programmes. This point of view is reflected also in the comparatively low weighting of the donations technical area in the Index compared to others, and by our heavier emphasis on longer term approaches such as equitable pricing strategies or licensing. I’d be interested in hearing others on e-drug if there are any circumstances where the feel donations can be considered an appropriate way to support longer-term access (outside of ad-hoc humanitarian efforts) – for example in NTD control / elimination / eradication.

The 2016 report has a lot of detailed information, and I would encourage people on the list to take a look - especially at the industry-level analyses. There is much more besides the information published: The research team at the Index are very happy to engage with list members and others in more detail, both now, and during next year's methodology review.

Cheers,

Danny

Danny Edwards <dedwards@atmindex.org>