C Appropriate Access & Stewardship

Examining how companies aim to increase appropriate access to antimicrobial medicines while ensuring they are used conservatively. This Research Area assesses companies’ access strategies for antimicrobial products in 106 low- and middle-income countries, alongside their global stewardship initiatives.

Large research-based pharmaceutical companies
Generic medicine manufacturers

Context

Rising antimicrobial resistance (AMR) poses twin challenges: ensure their appropriate use (stewardship) while addressing the lack of access for millions globally. Pharmaceutical companies can influence these two issues. To ensure access, they can put in place strategies, relating to product registration, affordability and improving supply chains. Regarding stewardship, the role for pharmaceutical companies spans a range of areas such as education of healthcare professionals (HCPs), surveillance, and ensuring marketing practices take account of the risks of overuse and misuse.


The leaders

Across this research area, four companies stand out: GSK, Pfizer, Novartis and Johnson & Johnson. All four demonstrate a range of activities across the indicators measured. Across access indicators, GSK leads, followed by Johnson & Johnson, Pfizer, Novartis and then Sanofi. All five companies have filed their newest antibiotics for registration in some countries in scope, and have considered the pricing and sustainable delivery of these medicines. In stewardship, GSK also leads, followed by Johnson & Johnson, Pfizer, and Novartis. Each of these companies provided evidence of stewardship in most areas, although Novartis lacks a surveillance programme.


In summary

For the majority of newer antibiotics, registrations appear to be lower than for older ones 
The Benchmark finds that newer antibiotics are currently registered in fewer countries than older products. To illustrate: 12 products in the analysis were introduced after 2011. These were (on average) filed for registration in fewer than five countries; the 24 products introduced before this point were (on average) filed to register in almost 30 countries. Several products stand out, most notably Johnson & Johnson’s bedaquiline – a long-awaited new medicine for tuberculosis. This is the only product introduced in the past five years, assessed by the Benchmark, that has been filed for registration in in more than 10 countries in scope – indeed, it has been filed in 23 countries. Products were included in this analysis where the year of their first global regulatory approval could be verified.


Two of ten generic medicine manufacturers report an equitable pricing strategy 
All large research-based pharmaceutical companies disclose an equitable pricing strategy that covers countries where access to medicine is likely limited. Equitable pricing strategies take some measures to ensure affordability. The quality of the strategies identified by the Benchmark varies; some are general strategies, whereas others are linked to specific products; some set prices at the national level, whereas others set prices for populations within countries. Out of ten generic medicine manufacturers analysed, Cipla and Mylan stand out for reporting an equitable pricing strategy. Generic medicine manufacturers generally price their medicines lower than those of their large research-based competitors. However, this practice on its own offers no guarantee that medicines will be affordable.

The line between marketing and educational activities appears blurred
The Benchmark finds that the line between marketing and educational activities appears blurred. Companies generally lack clear educational targets, use similar content and goals for both marketing and educational purposes, and some programmes are reported as having both marketing and educational purposes. The Benchmark excluded some HCP education strategies from analysis for too closely resembling marketing tools, and offering little or no educational content. Several companies, conversely, stand out for their good practices in this area. GSK, Novartis and Pfizer show evidence of having content independently developed and using mechanisms to mitigate conflicts of interest (COI), including policies of not paying attendees or speakers in some cases and/or in some programmes. Companies generally use congresses and/ or courses to deliver educational material.

Figure 40. Four antibiotics have been filed in more than half of the countries in scope.

Products introduced* since 2011 have been, on average, filed for registration in fewer than five countries, whereas older products have been filed in more than 25 countries. Four older antibiotics have been filed most widely, including the commonly used antibiotic amoxicillin/clavulanic acid (Augmentin™) by GSK. Johnson & Johnson’s bedaquiline (Sirturo.) is the only new antibiotic (past five years) that has been filed for registration in more than 10 countries in scope.

* Introduction refers to the year of approval by the US FDA, EMA or Japan’s PMDA or the year a product was introduced as reported by the company. Products were included in this analysis only where the year of their first global regulatory approval was reported.

Figure 45. Non-branded educational materials are the most common conflict of interest (COI) mitigation techniques.

Abstaining from branded materials and product-specific contents in educational materials are the two most common measures used by companies to mitigate COIs in AMR-related educational programmes. Not paying programme participants is also a relatively common measure, whereas not paying external speakers is relatively rare.

Range of mechanisms reported for mitigating conflict of interest in HCP education 
Companies report several different mechanisms and processes  to mitigate COI in their educational activities directed  at HCPs. Out of 29 programmes, 21 give information about  actions to mitigate COI; for most of these (18), content is  developed independently; almost a third (13) run without  branded materials; 11 do not require attendance payments  for participants; and six have no commercial team involved in  their development. In general, companies can develop clearer  policies and protocols for mitigating COI. One very effective  mechanism is to partner with a public organisation in the  development and running of educational programmes. Both  Johnson & Johnson and Pfizer are running educational programmes  with public health organisations such as USAID, National TB programmes, hospitals and other health facilities.

Nine companies are active in AMR surveillance programmes 
Out of 19 companies (including Wockhardt), nine are active in AMR surveillance programmes, with a combined total of 19 active programmes. Ten of these have a national focus, while the remaining nine are international. Eleven programmes aim to measure long-term trends in antibiotic resistance. Almost half of programmes (eight) have run for fewer than three years, while six have run for more than 10 years. Companies are running surveillance programmes across 147 countries, including 94 out of 106 countries where access to medicine is likely limited. Only three companies are conducting more than one surveillance programme (Cipla, Pfizer and Shionogi).

Figure 48. AMR surveillance programmes are being conducted in 147 countries worldwide.

Nine companies assessed by the Benchmark are engaged in surveillance programmes, active in 75% of countries in the world.

Four companies take steps to adjust incentives for sales teams
Out of the 18 companies in scope, only four are taking steps to adjust sales teams’ incentives. GSK demonstrates best practice in this area, decoupling all sales incentives for sales agents from volumes of sales. Shionogi does not remunerate its sales teams based on antibiotic sales volume. Two other companies are also working towards this. Novartis is taking steps to adjust incentives for its sales agents, reducing the variable portion in the overall compensation, while Pfizer will begin a pilot to fully decouple its agents’ antimicrobial incentives from sales volumes. 

At least one other company is taking a different approach at the product level. Johnson & Johnson’s new anti-tuberculosis drug, bedaquiline (Sirturo®), is provided solely through national tuberculosis programmes and therefore does not require any marketing materials. The company reports that it does not deploy any sales organisations for the sale of Sirturo® in countries in scope.

Figure 15. Decoupling sales volumes from sales agents’ bonuses: four companies are taking action.

GSK, Novartis, Pfizer and Shionogi report that bonuses are fully decoupled or that the company has taken steps towards adjusting incentives for its sales teams’ bonuses from the volume of antibiotics they sell.

In Appropriate Access & Stewardship, the Benchmark uses global antibiotic sales volumes to inform its selection of companies to analyse: the Benchmark assesses 18 companies in this research area. These comprise all eight large research-based pharmaceutical companies in scope and all ten generic medicine manufacturers. The scale of these companies’ sales volumes suggests that their policies and practices can likely have a significant impact on antimicrobial resistance. The Benchmark does not assess the activities of the 12 biopharmaceutical companies in scope so as to preserve the comparability of this group. Most of these companies have no products on the market. However, the Benchmark highlights the relevant activities of these companies where possible.



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