Lif Sweden is engaged in efforts to reduce emissions of pharmaceutical residues in the waters.
We asked Bengt Mattson, Policy Manager, Lif Sweden, about their projects and efforts.
Could you tell us about this work or something specific that you’re working on right now?
“The first area we moved into was the correct use and disposal of unused medicines. In the nineties, LIF worked closely with the Swedish pharmacy association, or the pharmacy monopoly in those days, Apotek AB. And after the deregulation of the pharmacy sector, we continued their work by providing information on how to correctly dispose of unused medicine and ensure people do not flush them down the drain, and that medicines must go back to the pharmacy.”
The idea behind that is to identify substances that may pose a risk to the environment, if, for example, they enter water systems from patient excretion. The same knowledge is valid when it comes to discharge from manufacturing facilities.”
“In 2005, LIF collaborated with Apotek bolaget and the Stockholm County Council to develop a classification scheme for pharmaceutical substances. IVL, the Swedish Environmental Research Institute is the impartial reviewer of all the environmental information that pharmaceutical companies share on fass.se. It’s still unique, the only one in the world. The idea behind that is to identify substances that may pose a risk to the environment, if, for example, they enter water systems from patient excretion. The same knowledge is valid when it comes to discharge from manufacturing facilities. That’s the next phase.”
One of the pillars is manufacturing effluent management, for which we have developed an extensive guidance document on how both our member companies and our suppliers should ensure that we do not have any unacceptable medicinal releases from manufacturing operations. That work is the focus right now.”
“When we first looked at unused medicines, we talked about patient excretion here in Sweden. And then since 2007, we have worked with IVL and other stakeholders here in Sweden on manufacturing releases. The work today is done through our European Trade Associations. Lif is a member of both the European Self-Care Association (AESGP) and the Innovative Pharmaceutical European Association (EFPIA), and I’m the chairman of their Joint Task Force on Pharmaceuticals in the Environment. Together we have developed the Eco Pharmaco Stewardship Initiative. One of the pillars is manufacturing effluent management, for which we have developed an extensive guidance document on how both our member companies and our suppliers should ensure that we do not have any unacceptable medicinal releases from manufacturing operations. That work is the focus right now.”
Read more: Pharma industry confronts growing problem of pharmaceutical waste
So what are the legal requirements when it comes to this issue?
“There are two things here. In manufacturing operations, you will always have environmental permits with conditions on the release of organic compounds through wastewater. That’s the legal framework for manufacturing operations. And then there is an ongoing revision of the urban wastewater treatment directive here in Europe that is focused on what comes from citizens. The proposal that is currently being discussed was published on October 26th 2022. The European Commission has proposed that for pharmaceuticals and cosmetics, there should be a so-called ’extended producer responsibility’ to upgrade Europe’s wastewater treatment plants with the kind of technologies that we use in our manufacturing onsite wastewater treatment plants to eliminate pharmaceutical residues from wastewater.”
The European Commission has proposed that for pharmaceuticals and cosmetics, there should be a so-called ’extended producer responsibility’ to upgrade Europe’s wastewater treatment plants with the kind of technologies that we use in our manufacturing onsite wastewater treatment plants to eliminate pharmaceutical residues from wastewater.”
“We believe it’s unfair just to focus on pharmaceuticals and cosmetics because there are a lot of other industry sources of potentially persistent and harmful substances. We are prepared to take our fair share of responsibility, but we don’t think it’s reasonable that we should be the only sector that pays for the upgrade of publicly owned sewage treatment plants.”
We are prepared to take our fair share of responsibility, but we don’t think it’s reasonable that we should be the only sector that pays for the upgrade of publicly owned sewage treatment plants.”
With the new requirements how successful do you think the reduction in pharmaceutical byproducts that get into wastewater systems would be?
“The technologies exist, and are used in our manufacturing facilities; we use technologies such as ozone treatment or activated carbon and can eliminate almost 100% of pharmaceutical residues. There are two challenges. One is cost, and the other is that these techniques are quite energy intensive. So there is a risk of driving the carbon footprint higher with carbon dioxide emissions from wastewater treatment plants.”
There are conflicting goals between chemicals and carbon.”
“There are conflicting goals between chemicals and carbon. So that’s a challenge, but there are a lot of discussions when it comes to the costs. It is assumed that it will cost several billion euros a year to make these upgrades and that is one of the reasons why we think it’s unfair that the only industries that will participate in this upgrade would be the pharmaceutical and cosmetic sectors. And there is concern that some products with very low margins, like some antibiotics, might be removed from the European market.”
Is there a danger that due to the regulations, you would see costs being pushed down the supply chain?
“If the pharmaceutical industry needs to pay at least a billion euros per year, that would need to be compensated somewhere. Of course, that would somehow be put on the price of the product. The directive says that it is the producer’s responsibility, and this responsibility is put on the market authorization holder in every European member state. I cannot see how we could push it backwards in the supply chain. It would be pushed onto the products. So for some prescription-free products that will come directly out of the pockets of consumers.”
Read more: New global study of pharmaceutical contamination in the environment
What might facilitate the work of pharma companies when it comes to decreasing their emissions and pharma residues in water?
“There are several ways to do that. One is particularly challenging, and that is green chemistry, where you redesign molecules, and try and make them more easily degradable or less hazardous. The challenge is that the molecules might be risky, as they are biologically active because that’s the way they work on human beings. Hence they will potentially have a biological activity on a water-based living organism. If we remove this biological activity, it will not work as a medicine any longer. And it’s also a challenge to make them easily degradable because if you make them easily degradable, they will degrade in the gut before they enter the body.”
So, a redesign or green design is one way. The other way would be the prudent use of medicines ensuring that we do not have overuse.”
“For biologics, like a jab or a shot, for instance, these can degrade very quickly. The problem is that many of them would need cold storage which is not necessarily a good thing. But that redesign is something we are looking into. If you would take a long-term view, more and more of the innovative medicines that come today are biologics rather than chemically synthesized tablets. So, a redesign or green design is one way. The other way would be the prudent use of medicines ensuring that we do not have overuse.”
“I often talk about what could be done when it comes to prevention. Infections could be prevented by robust vaccination programmes, so we wouldn’t need as many antibiotics to treat infections. Lifestyle changes could decrease the need for some types of treatment. A society that does not use more medicine than is needed would decrease the amount also of residues that will go with patients’ excretion.”
Do you think there will be a disparity in how seriously different countries within the EU will take the new regulations?
“It wouldn’t be the first time we would see a more rapid implementation in the northern or western parts of the European Union, compared with other countries. And of course, the costs will be high. Although the pharmaceuticals and cosmetics industries are set to pay for part of the upgrades, they will still come with costs to society as well. And budgets are stressed already.”
Together with IVL, Lif has developed a model for the environmental assessment of pharmaceuticals. How can it be implemented? What are the benefits?
“It builds on what we developed back in 2005 when we looked at the classification scheme for pharmaceutical substances. The development we’ve done with IVL ever since then, is that in addition to looking at patient excretion here in Sweden, you can use the same type of calculations we refer to as the ‘predicted environmental concentration compared to the predicted no-effect concentration’. You could either use that to look at urban wastewater, for instance, but you could also use that for manufacturing facilities and ensure that you do not have unacceptable releases from manufacturing. In this model, we combine the patient excretion perspective with the manufacturing effluent perspective, and we also add the carbon footprint of the entire value chain, all the way from the manufacturing of the APIs through the formulation of the pharmaceutical distribution and use phases.”
In this model, we combine the patient excretion perspective with the manufacturing effluent perspective, and we also add the carbon footprint of the entire value chain, all the way from the manufacturing of the APIs through the formulation of the pharmaceutical distribution and use phases.”
“The idea would be that this describes the environmental footprint of a product. And if you have these criteria in public procurement you would meet the environmental sustainability criteria as described in the model. You would be able to look at the best price instead of simply looking at the lowest price. In addition to being used in public procurement the same kind of model is already used by the companies themselves when they look for “hotspots” in the value chain where they use the same kind of methodology in their environmental assessments.”
Featured photo of Bengt Mattson (left): Gunilla Lundström
