V4 contribution to the Pharmaceutical Strategy for the EU

The current epidemic crisis has once again shown how greatly Europe is dependent on international supply chains in providing essential medical treatment to European patients. Today, we are at a crucial moment to develop a common strategy that all Member States will benefit over time and which will influence to prevent crises related to shortages of medicinal products. This issue is a matter of European Health Security, as well as an opportunity for European economic growth. In addition, further challenges of the EU pharma market persist regardless of the COVID-19 crisis and we expect the new strategy to deliver adequate answer to those problems as well. On the other hand, we should not lose sight of the fact that pharmaceuticals play a critical role in the sustainability of our health systems and

therefore, there is a need to strive for the right balance.

It is therefore necessary to strengthen cooperation between the Member States and the Commission to ensure the availability and affordability of medicines.

Availability of drugs requires stimulating investment in the production of active pharmaceutical ingredients (API), intermediates and medicines in EU, with a view to ensuring the resistance of the pharmaceutical supply chain under critical conditions. Independence from non-EU actors requires availability of raw materials. Over 60 per cent of the production of API and intermediates is localized in Asia where very often lower regulatory standards are applicable.

A second key for prioritization should be used to ensure affordability of treatments. Treating all patients require also access to innovation. Innovation therapies are rightly an indispensable element of modern health care, but they are extremely expensive to develop and purchase, rendering then unaffordable for many patients hence inaccessible in the Union as a whole. Therefore, the European Pharmaceutical Strategy should aim to ensure real availability and affordability of innovation therapies in all Member States. Availability alone is not sufficient, if the innovation is not affordable. Currently, some Member States cannot conduct negotiations on an equal bases with the industry. Asymmetric situations favoring marketing authorisation holders (MAH) convinced a number of Member States to enter into sub-regional ‘fair pricing’ initiatives. The Pharmaceutical Strategy should support Member States in negotiating affordability of medical innovation.

Specific proposals

Strengthening EU self-supply autonomy

• The new pharma strategy needs to contain actions that incentivize local manufacturing through appropriate competition and procurement rules, which could include a “security bonus”, i.e., additional points for local production strengthening European Health Security.
• In this regard that special focus should be put on manufacturing of active pharmaceutical ingredients (API) and generic medicine. Vaccines manufacturing capacities should be further strengthened at member state level as well.
• Increased production entails a strategic and gradual expansion of the European production. Priority shall be given to API, intermediates and drugs which are produced solely or substantially outside of the EU, yet constitute the basis of treatment in the most common diseases in European population.
• To phase in incentivizing measures, we need to establish a list of essential medicines where self-supply autonomy has the greatest public health importance.
• Scaling up the production of API, intermediates and drugs could be endured through the creation of a special fund at the EU level and announcement of calls for contract manufacturing where European companies that offer the lowest prices will be able to receive support for production.
• For the purpose of demand coordination, a two-sided platform mechanism should be established in order for API producers and API costumers could conclude sell and purchase agreements. Ultimately, the derivative market could develop and ensure the stability of supplies or storage options—similar to energy markets.
• We accept that procurement should reward manufacturers that invest in resilience and they deserve purchasing commitments. This reward should be proportionate to the Member States’ financial capacities.
• We need to reinforce global inspection capacities to ensure that APIs manufactured in third countries are of the highest quality and manufacturing is in compliance with labour law and environmental standards. No competitiveness advantage should be achieved through compromising such rules and standards.

Promoting equal and equitable access to medicines throughout the EU

• From the perspective of availability, we need to pay special attention to the situation of smaller markets which are often avoided by marketing authorization holders.
• In case of centrally registered medicines by EMA when the so-called “sunset clause” should be better enforceable. Today, this clause remains a dead letter and does not produce its legal effects, i.e., the suspension or loss of marketing authorization throughout the EU if the medicine is only available in one of the Member States.
• In case of innovative medicines for rare diseases and medicines with a low number of patients, where the production of national packages is problematic, option of marketing multilingual or “universal” packages in Member States should be supported.
• Public funding in research and development should be better taken into account in the course of pricing (public funding may take different forms and they should be better recognized: direct funding of basic science and clinical trials, building physical infrastructure such a laboratories and registries, scaling up of genome programmes globally, training medical forces workforces, tax credits and discounts, etc.).
• Pricing policies applied by originators should be rendered more transparent to ensure that pricing serves fair reward for innovation and no other underlying interests (acquisitions or marketing).
• A system of price cap for innovative drugs could be considered, especially when public funding was received in developing the treatment. The cap should be adaptable to the economic situation of the Member States. The introduction of such cap should not, however, prevent Member States and the industry to negotiate drug prices, for instance in the national reimbursement procedure.
• We should closely monitor parallel trade to detect where they result in availability problems and deteriorate differential pricing.
• Public service obligations of marketing authorisation holders and wholesalers should be enforced in a more efficient way to ensure that medicines are effectively available in all the Member States.
• We propose an EU wide telematics system that help to monitor stocks and forecast shortages throughout the whole supply chain. The new Eu4health program brings a great opportunity to achieve these objectives.
• We strongly support the single point of contact systems where national medicines agencies are connected in living dialogue.
• Regulatory incentives to promote innovation should be revisited in order to find a more balanced system, in this respect the results of the evaluation regarding the paediatrics and orphan medicines regulations is crucial.
• When it comes to marketing authorisation processes robustness of evidence should be preserved and accelerated regulatory pathways should only be applied—on an exceptional basis—in case of emergencies.
• The cooperation between Member States and actors of the pharmaceutical sector should be strengthened in order to improve the availability of the existing information and real-world evidence generation from disease registers, e-health records and electronic prescription records, pricing and reimbursement decision making processes, decision makings of business operators and clinical practice as well.