EURALex reports on the hottest topics in the field of healthcare and their impact on the European Economic Area (EEA) as well as on countries outside the EEA.

• Paediatric Regulation: its prospects for being implemented in 2007. How will this legislation impact on pharmaceutical companies?
• Human Tissues Directive: where should it sit? Is this Directive best placed within the medical devices, pharmaceutical or third pillar? What are the prospects for a speedy introduction by the European Commission and what is the anticipated impact on the healthcare industry?
• Parallel Trade: who benefits?
• Combination/Hybrid products: what is the optimal placement?
• Counterfeit Medicines: IP Rights; the 2nd Enforcement Directive. Should internet pharmacies be legal? The full picture, including the view from the ECJ and the national courts.
• Orphan Drug Applications: whilst processes have improved is the uptake of products slower than was first predicted? Track the full debate to assess the EMEA’s claims of success.
• Risk Management Plan: a help or a hindrance for companies; is the plan viable in its present form? How will risk management plans impact on European healthcare companies?
• Ethics Committees: should healthcare sectors merge their ethics committees to increase efficiency and avoid conflict.
• Pharmcovigilance: what are the current issues?
• Scientific advice & protocol assistance: how important are these advisory tools?
• Single Use Medical Devices and Re-use in General: Including safety issues especially proposals to oblige the European Commission to create legislation on needlestick.
• Patient Empowerment: is this to be feared or respected? What will be the implications for national healthcare budgets?
• Freedom of movement: patients; medical employees and products. Proposals by the Commission to clear up problems and more cooperation between the European Member States and healthcare systems.
• Animal Rights: are we in need of a re-think? Reduced animal testing should be on the horizon.
• Veterinary Medicines in the EU: maximum residue limit.
• Herbal Medicines Directive: the EMEA’s assessment.
• Food and vitamin supplements: ongoing updates.
• Biosimilar medicines: will this legislation increase interest in this field? This will bring potential risks which need to be considered. Are contingency plans in place?
• Traditional medicines: is current legislation sufficient?
• Electronic Common Technical Documents (EcTD): what is the document used for?
• Nutraceuticals and cosmaceuticals: is increased legislation necessary?
• Avian flu: are countries adequately prepared?
• Biotech Patents: regular updates and commentary on their status.
• National competition authorities: updated decisions and the impact of possible outcomes.