Pharmaceuticals

Innovative Medicines

Expensive “innovative” medicinal products pose new challenges to hospital activity, despite the added value of some of these products is not always clear. They influence hospitals financing models and organisation, also potentially leading to treatment rationing, unethical and ineffective from a public health perspective.

HOPE released in January 2017 its position paper Expensive medicines: Hospitals are concerned“, calling for greater attention on the consequences that several “innovative” medicines can bring about in hospital activities. It provides an overview of the current situation at European level – welcoming the 17 June 2016 Council conclusions – and calls for further development of Member States driven voluntary cooperation between relevant authorities and payers. Finally, it gives recommendations on possible actions to take at hospital and healthcare services level to address this issue.

Falsified Medicines

HOPE closely followed the EU legislative developments on the issue of falsified medicines.
In 2011, a Directive was adopted with the aim of preventing the entry into the supply chain of falsified medicines. Since then, the European Commission has been working on a number of implementing measures such as the delegated act adopted in February 2016 detailing the “safety features” which allow verifying the authenticity of medicines.

HOPE replied to a public consultation on the concept paper on the detailed rules for a unique identifier for medicinal product for human use launched by the European Commission in April 2012 and participated to stakeholder workshops organised by the Commission representing the healthcare providers’ perspective.

Clinical trials

A majority of hospitals are involved in research studies which often take the form of clinical trials. In 2012 the European Commission published a proposal for a revised Regulation on clinical trials. The new legislative text was adopted in April 2014 and will indicatively apply from mid-2016, once the EU portal and EU database for clinical trials will achieve full functionality.

HOPE considers the Regulation to be a significant improvement to the previous Directive 2001/20/EC and a clear attempt to streamline the authorisation of new clinical trials.

EU Projects

PHIS
Pharmaceutical Health Information System