Estelle Brosset and Aurélie Mahalatchimy consider both EU pharmaceuticals and medical devices law, as new health technologies may occupy either space, even though a separate body of EU law and policy, with its own logics, has developed for each. Beyond the new unitary European patent, the International Stem Cell case left a complicated precedent, with a need for legal definitions at pace with current scientific reality as well as ethical dialogue with civil society groups in Member States. Furthermore, while there is increased regulation and marketing of Advanced Therapy Medicinal Products, and regulatory improvements offered by the European Commission, the products themselves remain far from patients.
Estelle Brosset and Sandrine Maljean-Dubois
The European Union has gradually developed a comprehensive body of environmental legislation. Within this framework, climate change has been given a high priority and is a prominent area of the EU’s external and internal policy. In a fruitful interplay, the EU has driven the evolution of the international climate regime and tried to influence international negotiations. In turn, the international regime has urged the Union to establish common objectives and means to tackle climate change in order to implement its international commitments. EU legislation and the international climate regime have been in constant interaction and have evolved together. Their interactions played a major role in the shaping of EU regulatory climate action facing conflicting challenges of ambition, acceptability and effectiveness.