Our healthcare clients include the pharmaceutical industry, medical devices manufacturers, patient organisations as well as medical and academical associations across Europe. In a highly regulated healthcare sector, a detailed understanding and capacity to help shape legislative environments is vital to fully appreciate the impact of policy development and change.
We undertake regular political monitoring and analysis of healthcare policy developments in all our offices in London, Berlin, Brussels, Paris, Rome and Vienna so that we can be pre-empt and identify potential policy opportunities for our clients.
As one of RPP's core strengths, our work in the healthcare sector has a reach across all of our offices and ensures that we stay ahead in terms of fresh thinking on policy developments at both the EU and national level. Drawing upon expertise across these teams means that we can provide comprehensive coverage of our client’s policy areas, including in the following.
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Medical Device Regulation
RPP Healthcare has a comprehensive approach in working with medical devices companies on EU and national related medical devices issues. This includes in the area of EU Regulation on Medical Devices and the EU Regulation on In Vitro Diagnostic Medical Devices as well as on classification.
Across our offices we have a dedicated team with experience at the European Commission, the European Parliament and the national Parliaments in London, Paris and Berlin, as well as with regulatory agencies and Governmental Departments.
RPP also has a strong background in working on key pharmaceutical legislation, shaping the debate on key issues such as access to treatment, IP, novel therapies and data protection Pharmacovigilance is also an area that RPP has worked on before, particularly in ensuring that there is a cross-border consistency in medicines labelling and assessing the impact of pharmaceutical legislation and its implementation.
Rare Diseases Policy Development
RPP has worked extensively in raising the profile of rare diseases within EU legislation, particularly in working towards a European-wide definition for ‘ultra-rare diseases’ and ensuring its recognition within European and national policy making circles.
BREXIT and Mutual Recognition Agreements
In the UK, RPP has worked with policy makers within the UK Parliament and the Devolved Administrations to ensure that the principle of MRA’s forms part of the national debate on how best to ensure that there is conformity and alignment between the regulation and standards applicable for medical devices.