E-DRUG: Access to Medicine Index 2014 - Response to comments
-----------------------------------------------------------------------------------------
[Thank you Danny for your detailed responses - Moderator]
Dear E-druggers,
I'm responding to the questions and comments that have come up since we published the 2014 Index last week. We appreciate the interest and engagement shown so far.
@ Richard Laing - thanks for the informative email - it is very important to look behind the numbers in the Index, and read the narratives in the 7 technical areas. It is here that you can see clearly the leading companies in each area, the lagging companies, and those trying new approaches to support access. We also think its particularly important to check specific areas. For example, in the company report cards at the back of the Index, we make tailored recommendations to each company. These are based on the company's reported portfolio, and identified strengths and gaps. Here we highlight specific activities companies could be undertaking to improve access to medicines.
@ Chris Forshaw - thanks for the positive feedback. We thought it'd be helpful to note for all e-druggers that the report can also be downloaded in separate smaller parts, depending on your area of interest, which should help with bandwith issues. In the coming days, we will be adding a 'low-ink' version to the website, to assist with those intending to print off copies.
@ Wilbert Bannenburg - it's an interesting question you raise about GSK's performance in the context of the recent settlement in China. Corruption, bribery and unethical marketing practice is one of multiple area of analysis, and it is a sub-theme within which most companies have (broadly) performed poorly in the 2014 Index. GSK showed comparably strong performance across most of the remaining areas of analysis. It has strong governance of access to medicine, and an innovative business model focused on Africa and a comparably high level of transparency. The company is also a leader in the areas of licensing, and in R&D.
@ Joel Lexchin - I've answered your questions below:
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.
In the 2014 methodology we included how much of a company's total R&D budget is dedicated to relevant pipeline products. However, there are a few limitations when trying to measure and present this information in the report. Disclosure of this information is a barrier, which is why we measure company transparency in providing the data in a separate indicator. Further, comparing companies is also difficult, and corrections need to be made for company size. Companies also calculate R&D investment differently from one another.
2. In setting pricing policies do companies include middle-income countries or just limit themselves to low-income countries?
Regarding middle-income countries, of all the pricing strategies we analysed which took affordability into account (and were thus not straightforward tiered pricing policies) 43% included at least one middle-income country. Of these, 34% were tailored within countries to different population segments. This could be unpacked much further for an interesting analysis. We agree company strategies within middle-income countries are particularly important ones to watch, given the concentration of disease burden and poverty in these contexts.
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?
This is partially captured under the ethical marketing sub theme, as individual cases of reported breaches of codes of conduct, regulations and laws. The limitations of relying on regulatory and reporting structures in lower income countries however, means we aren't able to able to get a granular picture of this behaviour solely on the basis of breaches.
In terms of the products marketed in countries within the scope of the Index which we include for analysis, we ask companies to submit all marketed products that fall under the relevant indications for all diseases covered by the scope of the Index. We then analyse each product to assess the drug's suitability for use for the disease indication(s) described by the company, as per ICD10 codes. Product indications of the drugs included are verified against the information of regulatory authorities (such as the FDA and EMA), WHO treatment guidelines, company websites and scientific publications. Any products for which this was unclear were verified again with the company. 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.
4. How do company marketing codes compare to the WHO Ethical Criteria?
This would be an interesting point we'd like to pick up with you as we look at the methodology for Index 2016.
We expect company codes to correspond with, at the very least, the IFPMA code, which we agree has its limitations. In 2014 we also looked at a few additional data points - whether companies include third party contractors within the ambit of internal company regulation - which is discussed within the public policy chapter. We also looked at the extent of auditing, enforcement, and disciplinary action taken by companies - and company disclosure regarding these activities. We also asked companies to disclose evidence of marketing strategies and payments made in low and middle income countries - though company transparency was extremely limited in this particular area.
On the WHO ethical criteria - some companies have recently made commitments which exceed its recommendations (GSK committing to stop sponsoring/making payments to HCPs attending medical conferences) - while others have much further to go. It would be interesting to draw a more detailed picture here, and we'd be very happy to engage with you and others on what possible key additional data points drawn from the WHO criteria could be. Please feel free to get in touch directly, and we'll also contact you once we start the methodology process in the new year. There is also the question that codes, whatever the content, are not going to be sufficient, but - on the company side - need to be supported with effective auditing and disciplinary measures, and a corporate culture which does not tolerate such behaviour.
Thanks to all e-druggers for the discussion, and please get in touch if you'd like to discuss further.
Danny Edwards
Research
Access to Medicine Foundation
Danny Edwards <dedwards@atmindex.org>