Stepping up to the plate on antimicrobial resistance

IFPMAEduardo Pisani, Director General of IFPMA – the International Federation of Pharmaceutical Manufacturers and Associations.

Antibiotics have made modern medicine possible. Before the discovery of penicillin in 1928 and the recognition of its therapeutic potential, there were few tools doctors could use when patients came to them with common or minor infections from simple paper cuts. Today, complex medical interventions are made possible by the use of antibiotics.

However, seventy years on, the rise of antimicrobial resistance (AMR) is threatening the effectiveness of these tools. A hallmark of antibiotics is that they lose their effectiveness over time as bacteria naturally evolve and mutate and so become resistant to the medicine’s power.  Estimates from the UK Review Team on AMR predict that the death toll from drug-resistant infections could rise from 700,000 today to 10 million by 2050, and that the burden put on healthcare systems would amount to trillions of dollars.

These statistics and scale of the challenge of tackling antimicrobial resistance may seem daunting, but they have certainly galvanised action. In many ways, the global pharmaceutical industry is already at the forefront of leading action to address antimicrobial resistance.

In January this year, a major milestone in the global response to AMR was achieved, when over 100 companies and 13 associations signed the Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance. The Industry Declaration set out three key commitments. First, to reduce the development of drug resistance; second, to increase investment in R&D to meet global public health needs; and third, to improve access to high-quality antibiotics and vaccines for all. The industry also called on governments to commit to allocating the funds needed to create a sustainable and predictable market for these technologies while also implementing the measures needed to safeguard the effectiveness of antibiotics. There is a clear need for global coordination of stewardship, conservation, hygiene, and the creation and use of new commercial and incentive models for antibiotics, vaccines and diagnostics, to be delivered through local action.

The Declaration is a living document, and to keep up the pace with the evolving landscape of scientific breakthroughs and policy action, it will be updated every two years. Alexander Fleming himself is said to have called the discovery of penicillin “a triumph of accident”. Since, we’ve moved from analyzing basic samples of mold to developing new molecules through innovative private-public partnerships. As bacteria are getting “smarter”, researchers spend hundreds of hours in the lab to develop new medicines to address drug resistance. With 34 antibiotics and infection preventing vaccines within the global pipeline, the opportunity to bring resistance under control is within reach.

In one of the most comprehensive analyses to date on the scope of drug resistance, the World Health Organization points out that there are major gaps in actions needed across all 6 regions in order to prevent the misuse of antibiotics and reduce the spread of antimicrobial resistance. Perhaps one of the most eye-opening findings is that few countries (34 out of 133 surveyed) have comprehensive national plans to tackle AMR. While antibiotic resistance is a serious global threat, it does not provoke the same sense of urgency for all countries.

It is evident that there is no “one-size-fits-all” approach, and that governments need to acknowledge the global principles for action and implement them at local level. There are some countries that are already leading the way, but not all may start from the same level playing field. In Europe, there are countries such as Sweden, the Netherlands or the UK, who have invested in taking concrete actions to meet ambitious targets on AMR. In Africa, for instance, there is a real need for more and better data to understand the magnitude of AMR, while China is looking to increase training for consumers and medical professionals on proper use of antibiotics. Furthermore, the IFPMA Health Partnerships Directory lists over 20 case-studies of collaborative initiatives to combat AMR.

These issues are at the top of agenda of the forthcoming UN High-Level Meeting on AMR, where UN member states will be summoned to maintain a strong political commitment to tackle this global health threat.

IFPMA has an event in the margins of this meeting, where we will discuss how the biopharmaceutical industry will deliver on the commitments laid down in the Declaration. Building on the Declaration, over a dozen leading biopharmaceutical companies have developed a roadmap which lays out a number of practical steps in four key areas: reducing manufacturing pollution; addressing inappropriate use; improving global access; and developing a broad R&D ecosystem. Without collective action and local implementation of plans, we cannot expect real change. But when the global community rolls up their sleeves, we are that much stronger in tackling AMR.

Useful links

Antimicrobial resistance: millions of lives and trillions of dollars? Jim O’Neill, Commercial Secretary to the UK Treasury, author of the Review on Antimicrobial Resistance

Tackling antimicrobial resistance Michele Cecchini, OECD Health Division

Human rights due diligence of pharmaceutical companies: An important first

ForumRBCDamiano de Felice, Deputy Director Strategy, Access to Medicine Foundation (@damidefelice)

On Thursday 9 June, I will moderate the first ever session on pharmaceutical companies to be held at either the UN Forum on Business and Human Rights or the OECD Global Forum on Responsible Business Conduct. For starters, these conferences represent the two most important annual events organized by international organizations to promote corporate respect for human rights.

There are several reasons why it is surprising that a panel on pharmaceutical companies has been absent for so long.

First, the OECD understands very well the importance of tailoring international standards to different business sectors. It has already produced a Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas and, together with the Food and Agriculture Organization, a Due Diligence Guidance for Responsible Agricultural Supply Chains. It is currently developing a Due Diligence Guidance on Responsible Garment and Footwear Supply Chains.

Second, several scholars examined whether pharmaceutical companies – whose business is to research, develop, produce and market essential health products – are living up to their human rights responsibilities. Under international law, the right to access to essential medicines is a key component of the right to the highest attainable standard of health (i.e., the “right to health”). It is easy to see how some business decisions from pharmaceutical companies – such as favouring generic competition or avoiding excessively high drug prices – can have significant influence on whether vulnerable individuals can access crucial health products. In 2008, Paul Hunt – then UN Special Rapporteur on the right to health – even published specific Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines.

Third, the pharmaceutical industry seems to be ahead of the curve in terms of the adoption of human rights principles and norms. A recent report from the Business and Human Rights Resource Centre invited 180 companies from different industries to complete a questionnaire on their actions on human rights. The pharmaceutical sector was the only one where all companies had already adopted a human rights policy.

How can we then explain the absence of panels on pharmaceutical companies at the UN and OECD fora?

Conversations with business executives, government representatives and civil society activists pointed at two hypotheses.

To begin with, pharmaceutical companies are already under the attention of an older constituency of vocal health activists. This may have led those working on responsible business conduct to concentrate on other, less-crowded niches (such as extractives and consumer goods). For example, last year’s UN Social Forum – which focused specifically on “access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, including best practices in this regard” – saw almost no participation from the usual attendees of business and human rights events.

Additionally, most business and human rights specialists are experts in human rights abuses committed by companies while sourcing and manufacturing their products (that is, in the upstream side of global value chains). With the exception of a few reports on ICT companies and the right to privacy/freedom of expression, most business and human rights organizations focus on “upstream” topics, such as extractive companies and indigenous’ rights, apparel companies and workers’ rights, seafood companies and human trafficking, food/beverage companies and land rights, etc.

Against this background, the most important challenges for pharmaceutical companies lie in the way in which they market and distribute their products (that is, in the downstream side of global value chains).

Starting the conversation: the Access to Medicine Foundation

The willingness to explore what human rights due diligence means in the downstream side of global value chains and to understand the differences with its implementation in the upstream side was the trigger for the OECD to co-host a session on pharmaceutical companies with the organization whose strategy I lead, the Access to Medicine Foundation.

The selection of our organization was not by coincidence. The Access to Medicine Foundation is a non-profit organization that guides and incentivizes pharmaceutical companies to do more to facilitate access to medicine. In particular, we:

  1. Build multi-stakeholder consensus on a list of ambitious yet achievable actions for pharmaceutical companies to improve access to medicine;
  2. Analyse, measure and publicly report on the extent to which companies meet these expectations; and
  3. Use and diffuse this information to catalyse corporate change.

Our flagship product – the Access to Medicine Index – is a biennial report that ranks 20 of the largest pharmaceutical companies in the world on the basis of their performance against more than 70 indicators that have been agreed upon by multiple stakeholders after a year-long consultation process.

The panel at the OECD session will build on the work of the Access to Medicine Index because of the alignment between our indicators and the most authoritative international standards on responsible business conduct: the UN Guiding Principles on Business and Human Rights (UNGPs) and the OECD Guidelines for Multinational Enterprises.

I can offer three examples of this alignment here below.

  • The UNGPs and the OECD Guidelines both require business enterprises to adopt a policy commitment to respect human rights. The Access to Medicine Index assesses how companies integrate access-to-medicine issues within their corporate strategies and governance structures.
  • International standards emphasize the importance of interactive processes of engagement with relevant stakeholders. We reward companies that, through engagement with global and local stakeholders, better incorporate local needs and perspectives within their access strategies, increasing the likelihood of uptake and success.
  • All business enterprise are expected to carry out human rights due diligence, that is, an ongoing process by which they assess actual and potential human rights impacts, integrate and act upon the findings, track responses as well as communicate how impacts are addressed. The Access to Medicine Foundation raises the bar at several points of the pharmaceutical business model. For instance, leading companies are expected to take socio-economic factors into account when they set the prices of their drugs, and to differentiate both between countries and within different national population segments. Proof of strategy implementation is provided in the form of examples of corresponding price and sales data.

The success of the multi-stakeholder process of consensus-building at the Access to Medicine Foundation represents a very good starting point for a detailed conversation on how to ensure responsible business conduct from pharmaceutical companies. On 9 June we will discuss how to build on it and progress even further.

I hope to see you there.

Useful links

The 2016 OECD Global Forum on Responsible Business Conducts takes place in Paris on 8-9 June 2016. The event will be webcast live starting at 9.30 am CET on 8 June 2016.

The session on the pharmaceutical industry and responsible business conduct will start at 4.30 pm CET on 9 June. It will include:

  • Catherine Dujardin (Public Health Expert, Belgian FPS Foreign Affairs, Foreign Trade and Development Cooperation) will present what a government can do to incentivize pharmaceutical companies to contribute to the achievement of the Sustainable Development Goals, in particular with respect to the quality of medicines;
  • Sarbani Chakraborty (Head of Global Health Policy, Merck Serono) will comment on how to best integrate access to medicine in the business strategy of a pharmaceutical company;
  • Helena Viñes Fiestas (Head of Sustainability Research, BNP Paribas Asset Management) will share her experience as member of the Expert Review Committee of the Access to Medicine Foundation and investor lead for a collaborative engagement on clinical trials transparency;
  • Herman Mulder (National Contact Point, Netherlands) will introduce the role of NCPs in providing accountability for the actions of pharmaceutical companies, building on a recent Specific Instance at the Dutch NCP on the use of medicines in lethal injections;
  • Patrick Durisch (Health Programme Coordinator, Berne Declaration) will discuss the responsibilities of pharmaceutical companies with respect to the globalisation of clinical trials.