- Open Access
Policy cooperation and interface issues
© Vogler et al. 2015
- Published: 5 October 2015
To successfully meet new challenges, policy-makers may have to bridge between different stakeholders, countries, segments, products and types of health care. Issues regarding policy cooperation and interface management in this field may be related to bridging out-patient and in-patient sectors, medicines and medical devices (treatment packages), pharmaceutical pricing and reimbursement, international cooperation initiatives (e.g. joint procurement), international databases (e.g. price/utilization databases) and international comparisons and benchmarking (e.g. cross-country price/utilization comparisons).
Medical devices are playing an increasing role in medical treatment, in particular within the concept of 'personalised medicine' (or 'targeted medicine') which has gained increasing interest and funding including by the European Union.
However, in most countries, medical devices tend to be much less strictly regulated than medicines. Free pricing is usually applied to medical devices. Since there are no reimbursement mechanisms for medical devices, costs are, in principle, borne by patients or in the case of hospital care by hospitals. When it comes to the 'treatment package' composed of a medicine for treatment and a medical device for diagnostic purposes, substantial differences have been identified between European countries that have reimbursement systems for combined diagnostics and therapeutics (e.g. Germany, the UK and France), whereas for other countries (e.g. the Netherlands, Finland and Norway) no clear pathways for evaluation and funding of personalized medicine were identified . An example can be found, for instance, in the treatment of breast cancer, with trastuzumab and diagnostics .
Recent developments have, once again, highlighted the need for further cooperation between countries and stakeholders. Over the last years, the cooperation between competent authorities of European countries has been strengthened, thanks to EU initiatives such as the High Level Pharmaceutical Forum (2006-2008)  and the Platform on Access to Medicines (2010-2013)  and voluntary initiatives, such as the PPRI project (, see also E4). A major challenge for Member States cooperation was sofosbuvir for the treatment of hepatitis C, with its high price challenging the financial sustainability of publicly funded health care systems. In his key note at the 2015 PPRI conference (strand 3), Florent Dromzée (French Ministry of Health) draws lessons from the envisaged cooperation between EU Member States in the 'sofosbuvir case'.
In this context, supportive approaches through scientific evidence and cooperation between authorities and payers are highly valuable, and should go beyond the issue of pricing and reimbursement alone, but also consider pre-launch and post-launch activities (see , K2, P8). At the PPRI conference, Anna Nachtnebel (Ludwig Bolzmann Institute for HTA, Austria, O15) demonstrates the value of collaborative models for increasing efficiency of early assessment of medicines, at the example of oncology medicines, and Wim Goetsch (National Health Care Institute, the Netherlands, O13) highlights the need for strengthening cooperation between HTA agencies, taking sofosbuvir as an example.
The 2015 PPRI conference coincides with the 30-year anniversary of the Nairobi Conference on the Rational Use of Drugs (see also K3). The Essential Medicines List (EML) is an important tool to prioritise medicines reimbursement, as part of Universal Health Coverage programs in countries; however, the criteria for inclusion into EML have been an issue of discussion given the recent inclusion of highly effective and high-priced medicines in EML (O14).
The authors thank all members of the Scientific Programme Committee for their valuable support in the organization of the PPRI Conference on 'Pharmaceutical Pricing and Reimbursement Policies: Challenges Beyond the Financial Crisis' held in Vienna on 12-13 October 2015. They are grateful for their highly appreciated comments to the programme and the review of the abstracts. The list of members of the Scientific Programme Committee is available at http://whocc.goeg.at/Conference2015/ProgrammeCommittee.
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