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Estelle Brosset and Aurélie Mahalatchimy

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.

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Jean V McHale and Aurélie Mahalatchimy

Unlike regulation on the use of animal materials, the use of human materials in the EU is not regulated by one specific Regulation or Directive, despite a common legal base in public health, and common regulatory problems across the legal regimes for human tissues and cells, human blood and blood components, and human organs. Jean McHale and Aurélie Mahalatchimy consider the following: what is the legal classification, and consequently the applicable legal regime for human materials? How does EU law ensure their quality and safety for human applications? How does EU law facilitate access to human materials? What ethical questions do human materials raise and how does EU law manage them? McHale and Mahalatchimy conclude that the patchwork regulatory regime leaves a lack of consideration for important ethical concerns.