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Yannis Natsis, Policy Manager for Universal Access and Affordable Medicines at the European Public Health Alliance (EPHA), discusses the latest developments in market access across Europe, and the collaborative efforts its constituents are engaging in to improve it.  This article first appeared in Pharmafile and Pharmafocus.

Political correctness flew out the window in 2016 when it came to the access to medicines agenda in Europe, largely thanks to visionary leadership by the Netherlands. The problems of the current pharmaceutical business model – unjustifiably high prices, questionable innovative value of new drugs, the need to guarantee a fair return on public investment to name but a few – took centre stage during the Dutch Presidency of the EU in the first half of 2016, along with some recommendations for next steps.

Disruptive political developments

These are by far the most meaningful, strongly-worded and disruptive conclusions that EU Health Ministers have signed off in years. The then Dutch Minister for Health, Edith Schippers, spearheaded the negotiations during which she managed to demolish several long-standing taboos that stakeholders in Brussels and beyond had carefully fostered. She took many by surprise and surely made drug manufacturers very uncomfortable when she shone the spotlight onto the elephant in the room: the correlation between patent monopolies and the affordability and accessibility crises that many Europeans face today.

As a result of these Conclusions, the European Commission (EC) is currently conducting an evidence-based analysis on the impact of additional forms of patent protection – namely data and market exclusivities, as well as the supplementary protection certificate on the availability, affordability and accessibility of medicines and on the quality of medical innovation, notably on orphan drugs. It is a particularly bold and welcome step as there is an increasing political consensus that the incentives originally put in place to promote innovation in the field of rare diseases are being abused to maximise profit. Governments and the EMA need to send a clear signal to the market that rare cannot and should not mean orphaned, and the agency must change course and prevent the further orphanisation of the pharmaceutical regulation.

This incentives review will undoubtedly prove to be one of the most heavily lobbied items in the sphere of Brussels EU advocacy as it questions one of the sacred cows of the current profit-driven pharmaceutical model: the suitability of intellectual property rights. All eyes are on the EC, which needs to guarantee a transparent and impartial drafting process as well as a level-playing field for the balanced involvement of all stakeholders. It will be highly unfortunate if the study is contested due to its quality at the time of its delivery. That said, it is critical that national experts contribute data and solid evidence to the study so that it is not hijacked by narrow commercial and political interests.

Health Ministers mandated the EC to put together another equally significant yet often overlooked report on recent competition cases following the pharma sector inquiry of 2008/2009. National governments understand how powerful the tool of competition law and policy is and call upon the EC to be bolder and to intensify its work in this area. The 15 May launch of the official investigation into Aspen Pharma’s pricing practices for cancer medicines by the EC is certainly a step in the right direction.

The Drug Pricing Scenarios Project under the auspices of the Belgian and Dutch Health and Technology Assessment (HTA) bodies was another significant political development. Leading experts from Europe and the US were given the task to think outside the box and reflect on how to change the system of drug development. The four scenarios that came out of this exercise were a response to the pharmaceutical industry’s ‘There is no alternative’ argument, that they usually put forward insisting that there is no alternative to the prevailing model of medical R&D. The Fair Medicine Initiative, endorsed and financially supported by the Dutch government, is another example of a pragmatic and operational approach towards an alternative model of drug development, and a telling sign of the political will of certain European politicians to experiment and think outside the box in light of the paralysing high prices of medicines.

It is evident that 2016 marked the start of processes which will run well into 2017 and on into 2018. That said, a year later there are many who would like to see the June 2016 Council Conclusions on strengthening the balance in the pharmaceutical systems be forgotten so that their business as usual model is not disturbed. It is safe to say that the discussions we have had in Europe on pharmaceuticals since the so-called ‘Sovaldi phenomenon’ have been unprecedented. It was in July 2014 when, for the first time in France, the issue of the high prices of medicines as a threat to the sustainability of health systems was put on the EU Health Ministers’ agenda. The matter has never left the agenda since and governments in Europe, irrespective of their GDP, recognise it as a systemic challenge which will not go away.

That is why they cross their comfort zones and join forces with a view to increasing their negotiating power towards the pharma industry. Most governments in Europe are gradually growing aware of the fact that they have leverage not previously used when dealing with drug manufacturers; they comprehend that they stand a better chance of guaranteeing the sustainability of their healthcare systems if they unite and negotiate jointly. To this end, they continue to embark on collaborative horizon scanning and joint HTAs. They also exchange strategic information and conduct price negotiations in tandem.

It is important to remember that what seems today to be a new [modus operandi] was felt to be inconceivable just a few years ago. In fact, the most advanced intergovernmental regional collaboration of this sort between Belgium, the Netherlands, Luxembourg and Austria (Beneluxa) was born only in 2015 with Austria joining as recently as last June. The Valletta Declaration, signed in May 2017, follows the footsteps of Beneluxa and brings together the Southern Mediterranean EU partners. These newly-born initiatives are testing the water to see how far national governments can go in exchanging sensitive information and working together in a field where such collaboration was unthinkable before. Needless to say, these countries are well aware of the challenges ahead and the need to form a united front in face of the ever increasing prices of new drugs. These initiatives have the potential to be game-changers, but it is too early to say how successful or impactful they will be. It is nonetheless certain that politicians believe that the rules of the game need to change.

They are, however, unsure about how to change the system but are willing to look into alternatives. The access to medicines debate is a fairly recent phenomenon due to the harsh realities that the frankly unsustainable price structures are causing – this is why it is a topic area which is essentially unchartered territory for policy makers. Beneluxa and these fora pose new challenges as they consolidate the secrecy that covers decision-making in pharmaceuticals. They are shaping future policy developments with little or no possibility for democratic scrutiny with decisions being taken behind closed doors. In addition, they contribute to further policy fragmentation. Meanwhile, the EC seems to be sidelined, let alone the European Parliament.

What needs to change?

As for the next steps, it is important that governments either individually, or preferably in collaboration with like-minded countries, start with mapping the public support that goes into medical R&D. This goes well beyond the financial contributions like grants, tax breaks and incentives of all sorts and should cover the roles of universities, the in-kind contribution, the wealth of knowledge produced at publicly-funded research institutes and so forth. Moreover, they should increase public funding in medical R&D while attaching public interest conditions such as affordability and transparency plus provisions so that Europeans stop paying for their medicines twice or even three times. The role of public support in several therapeutic areas even exceeds the industry’s input, a fact which must be acknowledged. Furthermore, governments should foster a comprehensive dialogue as to what the real therapeutic needs are and to tie innovation to public health priorities – it cannot only be up to the drug manufacturers to define what the unmet medical needs are.

In addition to the above initiatives such as Beneluxa or the Valletta Declaration, we should invest in pilot projects, feasibility and benefits studies on alternative business models which move away from patent-based monopolies and exclusivities. The Fair Medicine Initiative is a first step but a lot more can and should be done, especially if more funding is pooled by more than one member state. In the mid-term, the silos between health ministries, national medicines agencies, HTA bodies need to be broken down in order to ensure policy cohesion and transparency. That said, good fences make good neighbours, and the integrity and independence of HTA bodies and medicines should be safeguarded and bolstered.

Regulatory capture is a clear and present danger, keeping in mind that the pharma industry’s interests are not always aligned with the public interest. Policy-makers need to reign in the EMA and effectively address the inconsistencies and the disconnect which often exists between what the Health Ministers decide and what the top European regulator is promoting. The agency’s decisions and initiatives are not merely technical and scientific – they guide the market and have far-reaching policy and economic implications, as was exemplified by the heated discussions around the controversial adaptive pathways pilot project and the push for accelerated approvals. It is thus necessary to critically review the role of the national regulators and of course that of the EMA.

Transparency is another area where progress can be achieved in the mid-term. Governments are starting to grasp the negative consequences of the shroud of secrecy which covers all aspects of decision-making in pharma policy-making, and legislation needs to be introduced to demand clarity of R&D costs. At the same time, governments need to experiment with honesty of pricing as for many countries in Europe, there is now robust evidence that confidentiality actually undermines their negotiating power and does not guarantee lower prices.

No more beating around the bush

Decision-makers have a choice to make: either they continue to invest their energy in endless pharma-driven debates around value and outcomes which essentially seek to justify the unhealthy prices of their drugs based on theoretical preventive savings, or they can adopt a multi-track approach which will send a signal that the business strategies of the manufacturers are no longer accepted and need to change now. The industry is an important stakeholder in this ongoing dialogue, but should not be allowed to monopolise