Last week the European Parliament postponed once again a key vote on the Urban Waste Water Treatment Directive amid growing controversy. MEP Ondřej Knotek (PfE/CZE) spoke in the EU Perspectives Podcast together with Adrian van den Hoven, Director General of Medicines for Europe, about why this is so relevant for protecting supplies of medicine.
“It is a clear controversy because we are in a situation that on one hand, the European Union is trying to return pharmaceutical production to EU soil, and on the other hand, we have logical environmental legislation that could almost drive producers, if I am honest, out of Europe,” said Knotek, adding “this is definitely not the correct approach.”
He said that it was the aim that EU policies should not contradict each other, but in this case, that’s what’s happening.
“It’s also the case that the impacted stakeholders warned about this situation, while the policy was being prepared. They tried to highlight these negative impacts, but they were not listened to. The legislation has been approved. And now we are in a situation where we are trying to figure out how to not step back from the protection of the planet, of the environment, but also how to not harm the businesses. And it’s not a simple equation,” continued Knotek.
“This Commission promised to listen more, so now they have a chance to do it.”
— MEP Ondřej Knotek (PfE/CZE)
The updated Urban Wastewater Treatmend Directive (UWWTD) brought in tighter rules introducing an extended producer responsibility (EPR) system, whereby producers of micropollutants from the pharmaceutical and cosmetics industries must pay for treatment costs of wastewater from various sources, including households and hospitals. However there has been much argument about the figures used by the European Commission in its impact assessments. The pharma industry says the real costs it will bear are so great that it could make the production of certain — particularly generic — medicines unsustainable.
Time pressures
One of the proposals now is to “stop the clock”.
“This is a very logical proposal that aims to stop the implementation and give the European Commission more time to come up with a second round of impact assessment calculations and appropriate cost analysis,” Knotek explained.
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“Even voices from the European Commission say these original calculations and all the supportive assessments were done in a very fast manner at the expense of quality,” he added.
Knotek further highlighted that in the European Parliament there was concern from across the centre and right wing political groups.
“I see the importance of stop the clock because the investors, the pharma companies, need to have clarity and of course they cannot wait for one month before this obligation comes into force and then change their business. Production is planned and the capacities are planned years in advance, investments are planned. So there is time pressure and this stop the clock would ease the situation,” he reiterated.
Not just about access
“The cornerstone would be to listen more to the industry. This Commission promised to listen more, so now they have a chance to do it. The Commission is preparing or considering some ways to ensure that of course the national healthcare systems will not bear this burden. And of course also not the pharma companies. So this equation is not easy to solve,” said Knotek.
He acknowledged too that “politically, for domestic politicians,” there are no easy answers.
“The impact is disproportional when it comes to generic medicine production because the margins are much lower than the innovative industry. And of course this has more impact in European geographical locations where the generics are much more often produced. So of course the member states that are impacted by this are louder, because it’s not only about availability of medicines in Europe, it’s also the workforce and national economies,” he concluded.
