With an array of unanswered questions, speculation abounds among Brussels stakeholders, who are eager to see more activities in the health sector from both the European Commission and the European Parliament, particularly as the discussions on the Data Protection Regulation and the Regulations for Medical Devices and In Vitro Diagnostics have an end in sight. So, what is the state of play surrounding these three areas, and how can the EU make a significant impact?
Antibiotics: Can Europe reduce resistance?
Antimicrobial resistance (AMR) is a shining example of the need for a Health in All Policies approach – it is an issue which intertwines veterinary medicine, environment pollution, and human health. In 2015, MEP Pierniocla Pedicini called on a One Health approach to combatting AMR in his own-initiative report on Patient safety and the WHO launched a Global Action Plan on AMR calling for communication, education, and training. As the European Commission previously discussed these points in the 2011-2016 Action Plan against the rising threats from AMR, it seems natural that the 2016 European Commission work plan would mention AMR. With the five-year project plan coming to an end, the Commission will be expected to report on the outcome of the action plan and demonstrate how it has contributed to combatting resistance in an effective, multifaceted approach.
HTA: Is a single market in health possible?
Next year will mark the launch of the third Joint Action on HTA, the scientific body working at the EU-level to prepare assessment methodologies for therapies and technologies, and which works alongside the HTA Network (HTAN). These initiatives have an ambitious mandate to create a single market for health products, which in principle could facilitate patient access, but the reality of this goal is complicated. Many Member States consider the decisions linked to HTA – uptake of technology, reimbursement, etc. – to be a national competency, one where the EU shouldn’t have a voice. While how – and if – the decisions taken will make headway in national environments remains to be seen, the development of the methodologies is of particular interest in itself. Will patient outcomes like shorter hospital stays or faster recovery time be taken into consideration? Will they position health as a long term investment and not a short term cost? Will the new HTA criteria facilitate patient access to safe and effective innovation? The biggest challenge for the EU will be to ensure that the Member States agree on the answers to these important questions.
Endocrine disruptors: What does the future hold for consumer products?
Discussions on the role of endocrine disruptors on our bodies’ production of hormones are not new in the Brussels bubble, but the perception of endocrine disruptors as a silent danger has grown since the adoption of the Strategy on Endocrine Disruptors in 1999 and REACH in 2007. The gradual implementation of aspects of the REACH Regulation over an 11-year period indicates that the legislation is being tackled one step at a time. In 2016, the “preparatory work” mentioned in the European Commission work plan, will become a critical component in realising the next steps, as endocrine disruptors are phased out of food production, household products, and other consumer goods. As more evidence becomes available more products and producers may be impacted, which is likely to have an impact on future business models and the way that goods reach our dining tables and shelves – decisions to be made by the European Commission which are likely to be met with mixed reviews.