Policy Principles on Cross-country Collaborations on Medicines’ Pricing and Access
16.01.19
The noise around cross-country collaborations on access to medicines has been constant. The results?
Not so much.
Not so much.
The concept seems simple enough but in practice, if cross-country collaborations fail to deliver faster, broader access to patients then it’s energy wasted.
Pharmaceutical companies in Europe are experiencing a new trend of collaboration between countries in areas that had until now been the sole competence of single national authorities. Initiatives such as BeneluxA-I, the Valletta Declaration group or FINOSE gather a few countries willing to join forces and collaborate on concrete projects, such as health technology assessment (HTA), public procurement, horizon scanning or price negotiation. These cross-border processes have the potential to transform the way medicines are currently purchased in Europe, and could have positive or negative implications on patient access and the financing of innovation down the line. It is therefore crucial for all parties that cross-country collaborations integrate the broader societal objectives associated with the purchasing of medicines early on: optimal patient access to state-of-the-art medicines, financing of innovation, and sustainability of public finances.
New processes, new structures, new systems to manage the introduction of new medicines need the companies that research, develop and deliver those medicines to engage. Companies will engage if these new processes, structures and systems can evidence that cross-country collaborations will lead to faster, broader access to new medicines for patients, that they will be an improvement on existing processes and that they will guarantee the confidentiality of sensitive commercial information.
This means that cross-country collaborations on access to medicines are perhaps at a crossroads across Europe today. Either they deliver on their initial promise or they run the risk of fading away.
Our perspective is that cross-country collaborations will only bring benefits to European patients if they are based on a number of guiding principles, published today and summarised below.
The principles outline the conditions for these collaborations to be designed and implemented in a way that gives them the best chance of meeting their objectives. They draw the line between acceptable and non-acceptable practices, and provide realistic recommendations that could help authorities in designing structures and processes that will engage pharmaceutical companies in joint collaboration. The EFPIA principles are articulated around 5 pillars:
1. Broader & accelerated patient access – the interest of patients should remain the primary consideration and driver. Cross-country collaborations are only relevant if they deliver better value to the patient;
2. Resulting from #1, these collaborations should streamline and speed up the existing framework, not make it more cumbersome or add delays. They should therefore not generate duplication and extra process burden.
3. These collaborations make the most sense between countries that are comparable in socio-economic terms and and/or have comparable healthcare systems.
4. They should remain voluntary for all parties, to make sure that the most relevant pathway, be it national or international, is used, and to generate the optimal outcome.
5. Finally the confidentiality of sensitive information including commercial information should be guaranteed, in line with current legislation. This is the key element that allows negotiations to happen between payers and manufacturers.
2. Resulting from #1, these collaborations should streamline and speed up the existing framework, not make it more cumbersome or add delays. They should therefore not generate duplication and extra process burden.
3. These collaborations make the most sense between countries that are comparable in socio-economic terms and and/or have comparable healthcare systems.
4. They should remain voluntary for all parties, to make sure that the most relevant pathway, be it national or international, is used, and to generate the optimal outcome.
5. Finally the confidentiality of sensitive information including commercial information should be guaranteed, in line with current legislation. This is the key element that allows negotiations to happen between payers and manufacturers.
We believe that these principles are fundamental to ensure that collaborations deliver on their potential to serve patient access to innovative medicines in the long-term. Actions driven by short-term perspectives to generate quick gains could put the supply and development of medicines in the longer-term at risk. We very much hope that the EFPIA principles can be of use in the formulation of policy aimed at improving patient access to medicines.
