Yesterday, the meeting between the President of the Government, Pedro Sánchez, and the CEOs of the pharmaceutical industry in Spain took place. Based on the information that has emerged from that meeting, at Salud por Derecho, we want to respond to what seem to have been several requests made by the industry to the president.
On one hand, the industry reported a “loss of sector competitiveness,” reflected in the declining presence in clinical trials and R&D of advanced therapies. On the other hand, it positioned itself against the European Commission’s proposal to reduce regulatory data protection from 8 to 6 years and market exclusivity for orphan drugs—those intended for rare diseases—from 10 to 9 years, arguing that such data protection is key to fostering innovation.
At Salud por Derecho, we believe that the evidence regarding the impact of data and market protections on innovation is limited, while their negative effect on access to and affordability of medicines is clear. For this reason, we advocate for reducing these periods to promote competition and lower prices.
Additionally, we argue that orphan drugs should only be considered as such when their economic profitability, without the incentives provided by regulation, is insufficient to justify investment in R&D. This would ensure that only developers who truly need it benefit from these incentives.
Furthermore, we propose that any exclusivity be conditional on transparency in development costs and pricing, which would allow for evaluating its impact and justifying possible extensions. We also demand that developers present a global access plan as a prerequisite for entering the European market.
Regarding the development of advanced therapies, Europe, and specifically Spain, have pioneering global success stories, such as the academic CAR-T therapies developed under the hospital exemption framework included in European legislation. We believe that the interpretative model applied in Spain should be extended to the rest of the EU countries and that this clause must be safeguarded and strengthened.
For its part, the industry called for a balanced development of the regulations currently on the table (such as the Royal Decree on Health Technology Assessment or the Draft Law on Medicines, for example) and an improvement in the timelines for access to and availability of medicines so that patients can obtain them as quickly as possible, “in a fair, equitable manner and ensuring the sustainability of the healthcare system.”
Regarding this, there are several points to consider: we propose a more detailed development of the Royal Decree on Health Technology Assessment, requiring pharmaceutical companies to clearly disclose tax incentives, subsidies, and any other financial support received, whether national or international. Additionally, it is essential to break down the costs of each development phase, from basic research to commercialization, to highlight the public sector’s key contribution in the riskiest stages.
As for the Draft Law on Medicines, it is necessary to advance in the implementation of World Health Assembly Resolution 72.8, which calls for greater transparency in pharmaceutical markets. Specifically, we support the disclosure of net drug prices, avoiding confidentiality agreements that perpetuate high prices and hinder the financing of treatments. However, the draft text of the bill, as reported by Demócrata, reiterates the confidentiality of financial agreement information. This opacity not only harms domestic patients but also raises global reference prices, making it harder for multiple countries to access and afford medicines.
Finally, the industry argued that the Urban Wastewater Treatment Directive would deal a severe blow to the pharmaceutical (and cosmetic) sector, as it would require them, almost exclusively, to bear the full cost of wastewater treatment to remove chemical microcontaminants.
The reality is that 92% of toxic microcontaminants in EU wastewater come from pharmaceuticals, according to the European Commission. The industry cannot continue to argue that bearing these costs will affect patient access. Until now, its environmental impact has been treated as an externality, allowing it to maximize profits at the expense of the environment. Regulating the removal of microcontaminants will bring benefits for both public health and environmental sustainability. But we must go further: it is crucial to integrate environmental impact across the entire pharmaceutical ecosystem. This also means considering it as an additional evaluation criterion for drug financing in the National Health System and holding companies accountable for pollution generated throughout their supply chain.
Photo: Moncloa
