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The European Federation of Pharmaceutical Industries and Associations (EFPIA) is increasing its lobbying budget. Behind the game-changing pharma-tech dynamic and the undisputed convergence of technologies which is reshaping the pharmaceutical landscape worldwide, “Connecting healthcare” is the latest EFPIA mantra, a new lobbying alliance and strategy. It highlights one of pharma’s favourite lobbying methods – the promotion of multi-stakeholder platforms, which while bringing stakeholders together, can also be a diversion from the real questions and problems and act as satellites and message amplifiers. They tend to repeat in an orchestrated manner complimentary message aligned with the pharma narrative while, “omitting”, or “forgetting” issues which the industry does not wish to talk about.

The impact of the “Connecting Healthcare” coalition is most felt in the shaping of the successor of the Innovative Medicines Initiative (IMI), the multi-annual, multi-billion public-private partnership (PPP). What is new, however, is that whilst IMI was a partnership solely between the European Commission and EFPIA, in “Connecting Healthcare” pharma joins forces -and lobbying power- with other business sectors such as the medical devices, diagnostics, digital and others. It was only a few years ago when the medical devices lobby group distanced itself and preferred to operate alone. Fast forward to today, Med Tech and the others realise that there is more that unites than divides them, even if the pie will most likely have to be split among more partners, leaving less money per trade association and their members.

Why does it matter?

Discussions are ongoing both regarding the successor of the Innovative Medicines Initiative, the future Partnership between the European Commission and the healthcare sector industries (tentatively called Innovative Health Initiative, IHI) as well as the future of the EU’s research framework programme, Horizon Europe. Huge amounts of public funds are at stake in both endeavours, thus the high industry interest.

There is nothing wrong with PPPs as long as the first P which stands for public, and is this case represents the European Commission, is properly represented and defended over the second P in the partnership. It is up to them and particularly the powerful Directorate-General for Research and Innovation (DG RTD) to learn from the mistakes made during the IMI, to guarantee public oversight, ownership, balanced representation. They need to ensure that IHI and Horizon Europe do not become industrial strategy vehicles in disguise. DG RTD needs to become an ambassador of the public health and affordability arguments most usually championed by their colleagues in DG Santé.

This is a test for the Commission’s clusters approach whereby various DGs are expected to work together. In doing so, the Commission as a whole needs to take seriously, calls by a wide spectrum of stakeholders for the European Partnership on Health to be driven by the public interest, not narrow commercial priorities. This is particularly pertinent as far as the priority setting and the establishment of the legal and governance frameworks of the new Health PPP are concerned.

In the words of the recent Finnish Presidency of the EU “there is an urgent need to focus on incorporating health objectives into all policies that have relevance for access to medicines, including research, innovation, trade and competition policies, and on efforts to find new ways to strengthen the strategic cooperation between Member States. It is equally important to monitor whether EU measures have the intended impact and to evaluate pharmaceutical policy at EU level and its objectives”. The above should not be overshadowed by pro-business arguments nor by the innovation principle school of thought. The same should -obviously and hopefully- apply to the highly publicized EU Cancer plan, the Cancer Mission and the planned Pharmaceutical Strategy of the Commission.

The Commission has been dragging its feet in releasing the respective staff working document which distills the various pieces of work commissioned and published in recent years on the role of incentives. This is a telling sign of the external pressure as well as the internal workings of the Commission. The pro-business, more powerful and influential –than DG Santé- Directorates General such as DG Trade and Grow attempt to water down any recommendations to fix the shortcomings and scale back the patent-based monopolies and exclusivities. Such an outcome would set a dangerous precedent for the industry. It understandably triggers an alarm in these DGs and beyond, all the way to pharma’s business allies on the other side of the Atlantic. The likelihood of a scale back should nevertheless not be discounted as the originators’ surprising defeat over the SPC manufacturing waiver showed last year. Besides, the budget impact and the sustainability threat posed by orphan drugs are too big to ignore, even in the eyes of the staunchest proponents of the pharmaceutical companies.

Pharma is not content with the negative turn the incentives-related discussion has taken. Having failed to prevent this from happening, EFPIA has raised the profile of antimicrobial resistance (AMR) as a policy priority. AMR is a platform which allows the industry to talk about incentives in a positive light (as opposed to orphans). Everyone agrees – the industry included- that the current antibiotic pharmaceutical market is “broken” as very few antibiotics have been produced in the past decades. What is the industry’s solution to the conundrum? More incentives. Although the European pharmaceutical lobby has not been forthcoming about what sort of incentives mechanisms they would be happy with, what they are aiming at is higher prices for new antibiotics, more unconditional public funding and market-based exclusivities in return for new antibiotics.

Why does it matter?

The pharmaceutical business sector, the pharmaceutical giants mainly, has for decades ignored –and continues to do so- the problem in antibiotics development and has invested in more profitable disease areas. Instead of complimenting pharma for having acknowledged their own failure to deliver, the approach should be one of recognising that pharma companies have dropped the ball and should be held accountable rather than be rewarded with billions more in public funds.

The European Commission is right to prioritize AMR as it undeniably is an urgent global public health threat. The pharmaceutical sector, while acknowledging this threat also sees a new substantial profit-making opportunity and has not hidden its preference for a new EU legislative initiative specifically on incentives for AMR. Meanwhile, in most EU capitals, AMR does not figure prominently on the national agenda, making it even more appealing and necessary for the European Commission to take action.

Should the European Commission decide to go down the path of introducing new legislation on AMR incentives, it should do so keeping in mind the principles of affordability, accessibility and availability of any new products. Heavy industry influence and lobbying, propagating market-based solutions should be counter-balanced with public-interest conditionalities (such as transparency and affordability provisions) attached to any new or existing funding streams and types of incentives. It is worth remembering that in the field of antibiotics and vaccines development, non-market based mechanisms have been very successful in addressing market failures caused by profit-driven market fundamentalism. Hence, it is high time we questioned the general hypothesis that only the private sector can advance drug & vaccine development. The Commission should seize the momentum to learn from and explore synergies with models such as Global Antibiotic Research and Development Partnership (GARDP) and the Drugs for Neglected Diseases Initiative (DNDi) and look at non-profit PDPs.

In the face of pharma’s inaction and continuous failure to address drug-resistant infections, even former Goldman Sachs economist and top AMR advisor to the UK government, Lord Jim O’ Neill changed his mind about offering the pharma industry market entry rewards and has favoured public-purpose ownership and manufacturing instead.

The industry’s strategy is clear: by mixing and grouping the incentives discussion under AMR, they aim to prevent any critical amendment of the European orphan drugs legislation and increase their chances of getting a diverse set of new incentives. Member States should therefore empower DG Santé to make sure that the public health, access and affordability arguments do not get overlooked nor sidelined during the Commission’s intra-service filtering, be it on the orphans review or the likelihood of new AMR incentives-specific legislation. Here are some recommendations on how to amend the orphan drugs legislation.

Nobody can foresee how the final text will look like. For the moment, political tensions aside, it seems that on the technical level, there is at least some consensus among HTA bodies, especially those with limited capacity and know-how, that they will be better off once this regulation comes into force. Pharma will not get what they hoped for i.e. an easier market access pathway but they will get a one-stop shop, despite the fact that Member States will retain their right to conduct their own clinical assessments – however, will they really make use of that option?

The joint clinical assessments will not be binding and they will not assess whether product (a) is better than product (b). Put simply, they will be merely inconclusive evaluations providing Member States with plenty of flexibility, exactly what governments need if they are to accept this regulation. In the coming months, negotiations will delve more deeply into the role of the European Commission in the final set up of the new EU-wide HTA system. The Commission will continue to demonstrate its spirit of compromise, but ultimately it cannot agree to something which they cannot legally defend. In other words, the Commission is ready to agree to much of what the Council is asking but not to everything and not at all costs. Pharma is expected to continue pushing on the mandatory uptake of the joint clinical assessments and the non-duplication of data requests from national competent authorities but they will not get very far.

Why does it matter?

Our predictions over the thorny issues and then non-speedy conclusion of the negotiations proved to be accurate. Let us just hope that the end product will not resemble the highly dysfunctional medical devices regulation with hundreds of confusing delegated and implementing acts. The new EU-wide HTA system should strengthen the role and capacity of HTA agencies in Europe. It should equip HTA authorities with “more teeth” towards pharmaceutical manufacturers so that they can do their job properly: rationalize pharmaceutical expenditure, enable meaningful innovation, and serve all patients’ needs. Additionally, the new system should be shielded against any legal attacks, as it is certain that the business sector will not shy away from challenging in court any unfavorable joint EU clinical assessments, the basis of subsequent HTA appraisals.

Furthermore, medicines shortages, an old new problem will be high on the political agenda -even without clear direction but with certain tension between parallel traders and big pharma as well as between East and West. Another highlight for the year will be the election of the new Executive Director of the European Medicines Agency (EMA) by the Agency’s Management Board sometime before summer. The approval pathways and their impact on access and affordability will be under further political scrutiny.