Asociación Española de Fabricantes de Química para la Salud
AFAQUIM
AFAQUIM es una Asociación empresarial, de ámbito español, con personalidad jurídica propia, con plena capacidad de obrar, y sin ánimo de lucro.
ID: 244557194341-77
Lobbying Activity
Response to Critical Medicines Act
26 Feb 2025
We are AFAQUIM, the Spanish Association of APIs Manufacturers and proud members of MfE, EFCG and the Critical Medicines Alliance. We are pleased to have been part of the collaborative efforts between authorities and stakeholders, where all voices were heard in the process of drafting a law on critical medicines that encompasses the entire value chain of the healthcare sector. APIs - Active Pharmaceutical Ingredients form the first link in the supply chain, and are crucial since they provide the pharmaceutical properties that make a medicine effective. In other words, without an active ingredient, there is no medicine. And we are committed to ensuring that medicines are produced in Europe with European active ingredients, guaranteeing that our citizens have access to the highest quality and safest medicines in the world. To achieve this, we need the support of the administration. Our stance is that both the raw materials and intermediates should be treated as a strategic and essential sector if we truly aim to strengthen the strategic autonomy of this value chain in Europe. One way to strengthen the Active Pharmaceutical Ingredients (API) supply chain and ensure there are no shortages is to ensure that drug procurement systems do not solely rely on the lowest price as the only purchasing criterion. We believe it is necessary to incorporate sustainability criteria and prioritize the use of Active Ingredients manufactured in Europe when making these purchases. We are aware that manufacturing in Europe is more expensive than in third countries, but the decision should be left to the prescriber and the end consumer, allowing them to decide whether they want to bear the extra cost for medicines of the highest quality and safety in the world. We would like to reiterate that producing in a way that is both environmentally clean (in line with EU standards) and cost-effective is challenging. But it is important to maintain consistency in our approach. While we strive to uphold the highest environmental and social protection standards in Europe, we can't justify choosing to purchase from countries that don't meet these same standards simply because of affordability, as mentioned on the pages 32 and 33 of the Draft Strategic Report of the Consultation. This would create a contradiction in our values. Europe is an open and competitive market, but it is essential to establish equal rules for all manufacturers, regardless of where the manufacturing plant is located. We believe a common and harmonized European pharmaceutical policy is needed, one that includes direct support for the sector, tax reductions, and relief from bureaucratic burdens if we want to ensure and enhance the manufacturing capacities of European companies. We believe that a future Critical Medicines Law, well-structured and taking into account the particularities of the different stages of the drug supply chain, will contribute to the strategic autonomy of our continent in such an essential area as health. It will ensure that Europeans have access to medicines manufactured in Europe, without shortages, and under equal conditions for all.
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