The EU pharma package – also known as the EU pharmaceutical package – is European law makers' effort to significantly tighten the legal framework for preventing and managing medicinal product supply shortages. It is focused not just on expanded reporting obligations, but above all on preventive governance and risk-management instruments. This article provides a structured overview of the key changes and assesses their practical implications for pharmaceutical companies.
EU pharma package for safeguarding supply of medicines
Supply shortages of medicines have become one of the most pressing health policy issues in the European Union in recent years. The compromise texts published recently explicitly establish the safeguarding of the supply of medicinal products as a key priority of the future pharmaceutical framework. The guiding principle of the reform is that patients should receive medicines when they actually need them, regardless of which Member State they live in. Accordingly, the EU pharma package systematically brings together access, availability and security of supply.
The main thrust is clear: In future, supply shortages should no longer be managed only once a crisis has arisen. Instead, early warning systems, risk assessments, preventive supply chain management, transparency towards the authorities and – in the case of products relevant to the whole EU – coordinated measures at EU level will be required in the future.
What concrete measures does the EU pharma package set out to prevent supply shortages?
The EU pharma package sets out a series of measures intended to help prevent supply shortages and safeguard the supply of medicines, which we will explain in more detail below:
- Early warning and reporting obligations
- Shortage prevention plan
- Further documentation requirements for the marketing authorisation holder
- Monitoring regimes
- Rules on critical medicinal products
- Supply obligation for products subject to regulatory protection
- Continuity mechanism
- Voluntary solidarity mechanism
- Involvement of the wholesale sector
- National exemption mechanisms
Early warning and reporting obligations as a key element of the EU pharma package
One key element is the significantly stricter early warning and reporting obligations for marketing authorisation holders under Article 116 of the draft new EU regulation on medicinal products ("New Medicinal Products Regulation"). In future, notice of both the permanent cessation of marketing of a medicinal product and applications for the withdrawal of marketing authorisation must, as a rule, be given to the competent authorities – as well as the European Medicines Agency (EMA) in the case of centrally authorised medicinal products – at least twelve months prior to the final delivery to the Member State in question. Notice of any temporary suspension in marketing must be submitted as early as possible and, in any event, at least six months before it begins. The same applies to any temporary interruption to supply that is expected to last longer than two weeks. Only in exceptional circumstances directly related to the interruption in supply may the notice be submitted retroactively as soon as the marketing authorisation holder becomes aware of the disruption.
Shortage prevention plan for prescription medicinal products and others
However, the reform does not stop at reactive reporting. In accordance with Article 117 in conjunction with Annex IV Part V of the New Medicinal Products Regulation, marketing authorisation holders are to maintain an up-to-date "shortage prevention plan" for medicinal products requiring a prescription and for other products to be determined in accordance with criteria under EU law. This plan must include in particular product information, a supply chain risk assessment including a supply chain map showing manufacturing sites and production shares, lessons learnt from previous shortages, a risk classification, risk control strategies and processes for identifying and reporting shortages as well as reviewing and updating the plan.
National authorities, the EMA and, in certain circumstances, the Commission may request the submission of the plan at any time; it must then be submitted within two days at the latest. In addition, the EMA is to publish guidelines on how the plan must be structured. To fulfil their monitoring obligations under Article 118 of the New Medicinal Products Regulation, the competent authorities may also request a "shortage mitigation plan" and further information from the marketing authorisation holder.
The marketing authorisation holder is subject to more documentation requirements
Even products that are not subject to the requirement for a shortage prevention plan are not left unregulated. Marketing authorisation holders for such products must perform regular, documented assessments of potential supply chain risks and, where necessary, implement appropriate risk mitigation measures.
EMA monitoring regime
In addition, there is an expanded monitoring system. The national competent authorities are to monitor continuously for anticipated and actual shortages; the EMA will perform this task in collaboration with the Member States for centrally authorised products or where action must be coordinated across the EU.
At the same time, the European Shortages Monitoring Platform (ESMP) is to be expanded and gradually made interoperable with national IT systems to consolidate reports and avoid duplicate submissions. National authorities are to communicate publicly actual shortages, their causes, mitigation measures, duration and available alternatives. In addition, the EMA is to operate an EU-wide website on critical shortages of Union concern.
The EU pharma package sets out new rules on critical medicinal products and security of supply
The new rules on critical medicinal products and security of supply are particularly far-reaching. Member States are to identify critical medicinal products using a common methodology across the whole EU. On the basis of this, the Commission will first release the EU-wide "Union Long List" in accordance with Article 127 of the New Medicinal Products Regulation. In addition, the EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) will propose a separate Union list of critical medicinal products in accordance with Article 131 of the New Medicinal Products Regulation. With the support of the EMA, the MSSG is to perform a prioritised assessment of supply chain vulnerabilities for the products on that list, in particular a lack of diversification and dependencies on individual third countries.
Building on this, the MSSG can make recommendations on matters such as supplier diversification, inventory management and regulatory flexibilities. Where there is a serious risk of supply disruptions that could lead to supply problems within the internal market, the Commission may also issue recommendations on national measures to improve security of supply. The provisions of the EU pharma package will be supplemented in future by a regulation on critical medicinal products, which also still needs to be adopted by the EU legislature.
Market availability: Supply obligation for products subject to regulatory protection
Another measure focuses on the actual market availability of products subject to regulatory protection in individual Member States. Under Article 56a of the draft new EU directive on medicinal products ("New Medicinal Products Directive"), Member States may require the marketing authorisation holder to make a product available on their market and supply it in sufficient quantity to meet patients' needs. To this end, they may require in particular that valid pricing and reimbursement applications be submitted, that procurement-related requirements be met or that a roll-out plan setting out the quantities and timetable for delivery be drawn up. This obligation is also found in Article 5a of the New Medicinal Products Regulation.
It is worth noting that these market availability rules are enshrined in Article 56a of the New Medicinal Products Directive with regulatory implications: If a request remains unfulfilled for three years, market protection and, where applicable, the extension of market exclusivity will not apply in the Member State concerned. Furthermore, an application for a generic or biosimilar medicine can be validated and reviewed as early as six years after the start of the regulatory data protection period.
Continuity mechanism in the event of permanent withdrawal from the market
In the event that a medicinal product identified as critical, a medicinal product additionally covered by criteria under EU law or a priority antimicrobial medicinal product is to be permanently withdrawn from the market, the New Medicinal Products Regulation also provides for a continuity mechanism in Article 116 (3a): Before permanently withdrawing a product from the market or submitting an application for the withdrawal of marketing authorisation, the marketing authorisation holder must publish a statement on its website indicating its willingness to transfer the marketing authorisation or to grant a "letter of access", share a link to the statement with the competent authorities and offer interested third parties the opportunity to continue supplying the product on reasonable terms. The aim is to ensure that products whose supply is critical do not disappear from the market without a replacement if third parties can maintain the supply.
Instruments for coordination and solidarity across the EU under the EU pharma package
This system is supported by instruments for coordination and solidarity across the EU. In the event of critical shortages of Union concern, the "voluntary solidarity mechanism" may be activated as a last resort if insufficient or no therapeutic alternatives are available, existing supplies are insufficient for critical indications, short-term measures will not provide timely relief and there is a risk of stockout. The EMA is then expected to facilitate information sharing, coordinate requests for support and, where necessary, facilitate contact with marketing authorisation holders.
Plans are in place to involve the wholesale sector to avoid shortages
The wholesale sector is also being more closely involved in preventing shortages. Member States may require wholesalers to notify the competent authority of the country of origin if the wholesaler intends to distribute the medicinal product to another Member State. On this basis, proportionate measures can be taken to prevent or mitigate shortages in the country of origin. In addition, wholesalers must work within their area of responsibility to ensure an adequate and continuous supply of a suitable range of products for the relevant supply area and must cooperate with marketing authorisation holders, national authorities and the EMA on measures to ensure security of supply.
Member States have scope to introduce national exemption mechanisms
Finally, the New Medicinal Products Directive gives Member States scope to introduce national exemption mechanisms where there is an acute shortage or where supply gaps cannot be addressed in any other way. If strict conditions are met, they may temporarily authorise the manufacture and supply of a medicinal product to alleviate or resolve a shortage, for example where a marketing authorisation has been withdrawn for reasons unrelated to quality, safety or efficacy. Furthermore, under very specific conditions, national law may also permit certain unused prescription medicinal products to be redispensed.
The draft outlines substantial penalties for breaches
The framework for sanctions is also noteworthy: In the case of centrally authorised medicinal products, the Commission may impose fines under EU law for breaches of the obligations set out in Annex II to the New Medicinal Products Regulation, which explicitly include the new obligations relating to supply shortages. The fine may amount to up to 5 % of the marketing authorisation holder's EU turnover; in addition, daily penalty payments of up to 2.5 % of the average daily EU turnover may be imposed. Member States must provide for effective, proportionate and dissuasive penalties for violations at the same time.
Supply shortages are becoming an issue of compliance and governance
The latest draft versions of the EU pharma package no longer treat supply shortages as an isolated crisis, but as a compliance and governance issue present throughout the entire product lifecycle. The approach is clearly preventive: Market availability, supply chain resilience, transparency, communication with public authorities and coordination across the EU are being consolidated into a coherent framework.
Though the level of detail is already high, the regulatory framework will be refined further. Numerous specific issues, in particular the content of the shortage prevention and mitigation plans, are to be set out in detail in delegated or implementing legal acts and in EMA guidelines. Companies should therefore closely monitor the legislative process and review their governance, data, supply chain and escalation processes now to ensure they meet the foreseeable requirements.
It is already worth starting to align processes with the future requirements now, particularly for holders of marketing authorisation for critical medicinal products or those relevant across the EU.
