For years, the environmental debate in Europe has not been discussed. The reduction of emissions, the cleaning of rivers, and the protection of ecosystems are not negotiable and have been legislated in line with this. However, some of the decisions, without questioning the objective, have opened cracks in specific sectors; they have even caused fractures in other pillars of the welfare state. That is precisely what is happening with the European directive on the treatment of urban wastewater, approved at the end of 2024. On paper, it represents a significant leap forward in the fight against microcontaminants; but in practice, it has generated concern in the health sector due to its possible effects on access to medicines, especially generics. Why?
The European directive updates legislation on wastewater after three decades in force (1991). One of the novelties is the implementation of advanced quaternary treatments in treatment plants. This process eliminates chemical residues in very low concentrations, but potentially harmful to both the environment and health and which are very difficult to remove, so it implies millions in investments throughout the European Union. The key is who pays for it.
Two industries singled out and a high price
Brussels' reasoning is clear: whoever pollutes, pays. The directive regulates through its article 9 the concept of Extended Producer Responsibility (EPR), which basically obliges certain sectors to bear the majority of the cost derived from these new purification systems. Under a laconic "any of the products listed in Annex III" lies a designation for two specific industries: manufacturers of medicines for human use and cosmetic products.
And the price to pay is not small. The text stipulates that these sectors shall cover at least 80% of the costs associated with the implementation and maintenance of advanced treatments. In addition, they will have to assume additional expenses related to the collection and reporting of data on their products, including their danger and biodegradability. The distribution will be carried out proportionally, based on the volume of products marketed and their environmental impact.
It is at this point that the friction between the regulation and the affected sectors -pharmaceutical and cosmetic industry- is generated. Both consider that other industries also contribute to this pollution and have been excluded from obligations.
The sector mobilizes
In a report prepared by AESEG (Spanish Association of Generic Medicines) in collaboration with six other scientific societies, they lament that the directive does not also include the pesticide, biocide, veterinary medicine, food additive, industrial chemical, and personal care product industries, with which they could share the burden of the required investment.
The document argues that these sectors could be significant sources of microcontaminants in urban wastewater, thus contravening the spirit of the "polluter pays" directive itself, and they urge its review.
The wastewater directive relies on an impact assessment report that estimates that human-use medicines represent 59% of the substances that reach wastewater treatment plants and 66% of the total toxic load in them. According to AESEG, these estimates would have been made “from a theoretically designed computer model” and “not from laboratory tests”, which is why they doubt them.
The AESEG report states that “the European association of generic medicines, Medicines for Europe, has publicly stated that, while the Commission attributes, based on theoretical estimates, 58% of the total toxic load generated by all industrial sectors to four medications (telmisartan, dipyridamole, candesartan, amiodarone), according to the laboratory data required by the EMA for environmental risk assessments, this load would be well below 1%, according to laboratory test data accessible through various sources such as the FASS database or the Norman ecotoxicology database”.
Thus, they consider that the directive is discriminatory, selective, and not very transparent.
Who pays what?
The directive commits the Commission to periodically assess whether other products should be included in the extended producer responsibility system based on the results of urban wastewater control and the latest scientific data; but for the moment, it establishes that the pharmaceutical and cosmetic industries will have to assume 80% of the costs of the new purification systems.
What the text does not specify is the concrete distribution between both sectors. Studies by the JRC (Joint Research Centre) indicate that the pharmaceutical industry will assume 66% of that 80%, with the majority falling on the generic drug industry (60%), when its market share in Spain is valued at 21%.
The impact
Several European sector associations —among them Medicines for Europe, EFPIA, or Cosmetics Europe— have appealed the rule before the General Court of the European Union (GCEU). They argue that the cost allocation is disproportionate and that it is based on disputed estimates.
Beyond litigation, the debate takes on a particularly sensitive dimension when it moves to the healthcare system. The financing model proposed by the Directive has direct implications for the economic viability of generic medicines, an essential pillar for guaranteeing access to treatments on equitable terms. The problem is structural. Generics operate in a highly regulated market, with prices set by the administration and subject to constant downward revisions. Their margins are reduced and their sustainability depends on large sales volumes. In this context, the imposition of new costs—without the possibility of passing them on to the final price—can strain their profitability to the limit.
The potential consequences go beyond a business matter. If certain medications cease to be economically viable, they could disappear from the market. This would not only reduce the therapeutic options available but could force the healthcare system to resort to more expensive alternatives. The result would be an increase in pharmaceutical spending and, ultimately, additional pressure on the sustainability of the National Health System.
If certain medicines stop being economically viable, they could disappear from the market
The impact would be especially relevant in countries like Spain, where the reference pricing system has intensified the erosion of margins in the generics segment. It is not a minor detail: according to data handled by the sector itself, a very significant part of first-line treatments in primary care is based on this type of medication. Furthermore, a large proportion of the drugs considered critical by European authorities precisely belongs to this category.
The risk, therefore, is not abstract. It affects the availability of essential medicines, the stability of supply chains, and, ultimately, the quality of healthcare. All this at a time when the European Union itself has identified strategic autonomy in pharmaceutical matters as a priority, with the aim of reducing external dependencies and strengthening production within the continent.
Industry requests as the calendar tightens
Faced with this scenario, the sector defends that environmental sustainability and health protection should not be posed as opposing objectives. It calls for a review of the burden sharing that takes into account the real contribution of all stakeholders involved and that avoids excessively penalizing a key segment for the healthcare system. It also asks to activate the safeguards provided for in the Directive itself to protect access to essential medicines.
The pharmaceutical industry, moreover, emphasizes that it already has mechanisms to mitigate its environmental impact, from waste management systems to drug collection initiatives such as the SIGRE system, widely implemented in Spain. It does not question the need to move towards more sustainable models, but it does question the specific design of a measure that, in its opinion, may generate unwanted effects.
The calendar adds another element of pressure. Some of the most relevant provisions will begin to apply from August 2027, which leaves limited room to adjust the regulatory framework or introduce corrections.