Expert insight

Help wanted in fight against AMR: World Pharma Association wants to see incentives – but also more regulation

6 November 2017
  • Thomas Cueni Director General

Help wanted in the fight against AMR: World Pharma Association wants to see incentives – but also more regulation.

This interview was first published on Medscape Deutschland

Antibiotics resistance is a global problem. At the World Health Summit 2017 in Berlin experts issued an urgent call for new developments and more research so as to be armed in the event of any emergency. Yet, so far, there’s far too little happening, comes the complaint. Thomas B. Cueni, director-general of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), explains why this ominous development is taking place and sets out his own ideas for solving the problem.

Medscape: Is the industry making too little money out of antibiotics?

Cueni: That’s too simple a way of putting it. The problem is much more complex. First, research into new antibiotics is a scientific challenge. Then, it’s hard to recruit patients for cliincal trials, the restrictions are substantial and development is expensive.

Unlike with cancer medicines, antiobiotics do not yet benefit from any broadly recognized approval procedure that, as early as Phase II, grants approval to very promising drugs. What’s more, investments are risky because the risk that the research will fail is high.

Ultimately, we don’t as yet have a long-term, sustainable business model. Here you have development costs and risks that may be compared with other drugs. But then there’s a new product generating hardly any sales because it must be kept in the cupboard as a reserve antibiotic. The G-20 summit did reach a broad political consensus that there must be financial incentives for investments in R&D into new antibiotics.

Medscape: Government monies that support research in the private sector are to some extent very controversial. What’s your view?

Cueni: My feeling is you’ve got to look at this in a differentiated manner. Nobody can solve the problem of antibiotics resistance on their own. Increasingly, there are partnerships between public authorities and private sector industry as we can see with Ebola or neglected tropical diseases such as tuberculosis and malaria.

But, right now, there is no sustainable business model for antibiotics. Each year, at least one or two new antibiotics are required. Firms that are active in this area must wonder whether this is sustainable given the development costs and risks. What’s more, they have to invest in their plants and equipment (assets).

Today, there’s widespread agreement that regulations in the environmental field are required to prevent businesses from putting huge volumes of antibiotics into the environment, as is happening in India, say. That’s the way resistant pathogens spread out ever more widely.

Medscape: You’re referring to the fact that last Spring journalists discovered that bodies of water around pharmaceutical plants in India are contaminated with antibiotics. In fact, it ought to be entirely self-evident that the industry should not throw antiobiotics down the sink. Why don’t you as an umbrella organisation bring your own colleagues into line when it comes to environmental requirements before launching demands for government regulation?

Cueni: Occasionally, voluntary action has its limits. It’s not enough that five or ten firms say we’ll stick to environmental standards, and then the 50 others say generic antibiotics are so cheap that investments in this field are simply not worth it.

A rethink is required here, whether through regulations in the area of „good production practice“, or through an agreement among buyers who commit to purchasing solely from firms in a position to certify that all their products have been cleanly produced.

This requires them to be transparent about where the raw materials for antibiotics originate. That can’t just be a voluntary arrangement. For, only a few firms would then be involved and the rest wouldn’t care a jot. Here the World Health Organisation and governments must go along with this and commit to purchasing for their health systems only from certified firms that abide by quality standards.

Medscape: On the one hand, businesses act according to the laws of a market economy, on the other they are to be subsidised with public funding. How can this balancing act be sustained without the threat of legal action?

Cueni: I’m fundamentally pretty cautious when it comes to subsidies for research. But in the battle against AMR (antimicrobial resistance) public-private partnerships have a role in basic research and early development.

To really get hold of the new antibiotics we need it seems to me imperative either way to have a system in place that rewards those who do research in a sustainable and successful manner. There’s always the possibility of agreeing on a higher price right at the point of market launch if a new antibiotic is being brought to market so that the manufacturer need not cover this only via its sales revenue.

Medscape: But not every country can pay these higher prices, surely?

Cueni: This issue is unresolved. One must indeed differentiate between developing and industrialised countries and one can well imagine linking incentives for research and development to ‚access’ requirements/conditions. But we simply cannot afford to wait another 20 years before the international community, G20 or WHO have agreed upon a solution.

Certain countries, the USA, Germany, Great Britain and the Scandinanvians, might lead the way. The issue here is not just higher prices but reward for market entry, or a kind of flat-rate fee for a successful development.

Medscape: Getting public funding for new antibiotics is one thing, but public funding for established antibiotics so that they don’t disappear from the market is quite another story. Many doctors in clinics say this problem is just as urgent if not even more urgent.

Cueni: This is a case of shortages and supply bottlenecks because even generic firms producing on favourable terms say they can no longer produce at that price. This illustrates the particular problem of simply looking at cheapness.

There should be greater awareness that quality, availability and environmental constraints are required if one is to combat the build-up of antibiotic resistances. But this also means that the same conditions must apply to all. It’s out of the question that a few manufacturers stick to the rules and the others simply supply at ultra-low prices.

Medscape: Behind closed doors many suspect that perhaps artifical shortages are being created so as to negotiate higher prices.

Cueni: That’s nonsense. I utterly reject such assertions. The problem is akin to that with vaccines: If the pressure on prices is so strong that even the lowest-priced generic firms say we can no longer manufacture at that price then I think it’s out of order to say the industry is at fault.

Medscape: Pharmaceutical companies themselves officially blame supply bottlenecks on quality defects among suppliers of raw materials.

Cueni: This goes hand and hand as well with the price spiral. I represent the research-based firms that are not renowned for acting like cheapskates. So one must wonder if all this focussing on the cheapest possible price has not gone too far. That impacts upon availability, upon quality and upon the build-up of antibiotic resistances.

Medscape: In your view, how can one keep established antibiotics on the market?

Cueni: If one pays a slightly higher price for antibiotics that are already on the market and one wants to keep them there, then this is pretty marginal for overall health costs compared to the risk one incurs if they are no longer there. If one considers the costs of unavailable antibiotics– avoidable deaths, amputations, periods in intensive care because of septicaemia–then one must ask oneself whether the cheapness of an antibiotic is truly the right criterion for fixing its price.

Medscape: What would you like to see so that the political debate around antibiotic resistance finally bears fruit?

Cueni: I think we must all walk that extra mile and think out of the box. The industry is today very open to regulations that guarantee compliance with envioronmental standards and an appropriate treatment of antibiotics. That cannot happen on a voluntary basis, as a „coalition of the nice“ so to speak.

A lasting solution to the problem of antibiotic resistance requires a further discussion about sustainable market incentives. Political leaders at the G20-summit in Hamburg agreed this and we are grateful that Germany is taking the lead. The debate won’t be easy. For countries don’t just want to throw money at industry but to know what they’re getting for it.