EU Pharma Package: Compromise Text Published – Best Efforts Required (Part 2)
After a 10-year process, the compromise text of the new EU General Pharmaceutical Legislation (GPL or Pharma Package) has been published and will soon become law. This blog post discusses the 10 most important changes for company pipelines, transition mechanisms, interaction with other laws, and next steps, and concludes that best efforts will be required from all stakeholders, including Member States, to make the new provisions work and create an attractive environment for medicinal products in the EU – including the interaction between with the Critical Medicines Act (compromise text adopted on 12 May 2026) and the Biotech Act (which is in progress).
Introduction
Following its adoption in December 2025 (see our previous blog here), the compromise text of the Pharma Package was published on March 6, 2026. The Pharma Package comprises a new Pharmaceutical Directive (PD) and a new Pharmaceutical Regulation (PR). The adoption follows a 10-year preparation period that started in June 2016, and three years of discussions between the European Commission, the European Parliament, and the Council of the European Union (i.e., the Member States).
The texts remain provisional, as the European Union (EU) legislators have yet to endorse the final versions. Formal adoption and publication in the Official Journal of the EU are expected by the end of the year. This will trigger a 24-month transitional period for many of the new provisions, with the notable exemption of certain measures that will apply earlier.
Note that the numbering of the provisions referred to in this blog may change in the final version.
- Reduced and Modulated Regulatory Protections
- “Best Efforts” Launch and Supply Obligations in Light of U.S. MFN Provisions
- Expanded Bolar Exception: Determining “Day 1,” Achieving Compliance
- Orphan Medicinal Products: A Balance of Losses and Wins
- MA Exceptions – New Rules for Pharmacy Compounding and ATMPs
- A New Voucher for Antimicrobials: A Global First, But Modest
- Changes to MA Procedures and Paediatric Investigation Plans: Some Streamlining but New Obligations
- Stricter Environmental Requirements
- New Rules on Monitoring and Management of Shortages
- Biotech Act: Additional Changes
- Transitional Mechanisms and Next Steps
1. Reduced and Modulated Protections: From “8+2+1” to “8+1(+1)+1”
Under current EU law, a so-called “8+2+1” framework applies. This provides for eight years of regulatory data protection (RDP), during which third parties cannot rely on the originator’s marketing authorization (MA) data to obtain approval for generic or biosimilar products, followed by two years of regulatory market protection (RMP), during which such products cannot be placed on the market. Together, these periods result in 10 years of protection before generic or biosimilar entry. An additional one-year period of RMP may be granted where a new indication demonstrates a significant clinical benefit.
EU lawmakers agreed to reduce baseline RMP from two years to one year and to maintain the possibility of a one-year extension for a new indication.
The GPL also introduces a modulated extension mechanism in which the “lost” year of RMP can be earned back where:
- The product addresses an unmet medical need; or
- The product contains a new active substance, and
- the MA applicant runs comparator trials and applies for EU approval first (or within 90 days of its first global filing); or
- the MA applicant runs comparator trials and clinical trials in more than one Member State; or
- if comparator trials are not feasible, the MA applicant runs clinical trials in more than one Member State and applies for EU approval first (or within 90 days of its first global filing).
The agreed definition of “unmet medical need” is broader than in the Commission’s original proposal. A medicinal product addresses an unmet medical need if it targets a life-threatening or severely debilitating disease, and either (a) no treatment is authorized in the EU, or (b) it offers a clinically meaningful improvement in efficacy, or in safety with comparable efficacy, compared to existing treatments. This test resembles the “significant benefit” approach as set out in the current orphan designation criteria. If it is interpreted along the same lines, it may ensure greater regulatory predictability, although its practical application will depend on future guidance from the European Medicines Agency (EMA).
The compromise text specifies that the cumulative duration of the RMP may not exceed two years, except in case where a one-year RMP was granted for a new therapeutic indication with significant clinical benefit (resulting in an 8+1(+1)+1 structure).
Bottom line: RMP protection is shortened by one year compared to current law, unless the applicant fulfils requirements to gain back the lost year. Whether the loss of one year RMP (and the corresponding reduction in the risk-adjusted net present value (rNPV)) can be avoided will depend on clinical development and global sequencing of MA applications.
A critical factor will be the assessment of unmet medical need: a refusal to grant unmet medical needs (UMN) status can have negative effects not only for RMP, but also for national pricing reimbursement discussions. the impact on pipeline products will therefore depend on how the concept of UMN will be developed over the coming years, and applied in practice.
See PD, Articles 80-81.
2. Best Efforts Obligations to Launch and Supply – Sharp Consequences
The Commission’s initial proposal of April 2023 provided for a “launch conditionality” mechanism, whereby RDP would be reduced from eight years to six years, with an option to gain back the two lost years by launching the product in all Member States. Instead of this mechanism, the PD contains a series of “best efforts” obligations to engage in pricing and reimbursement procedures and launch products in Member States seeking access to the product.
Under the PD, where a medicinal product benefits from RDP/RMP or orphan market exclusivity, a Member State may request the MA holder (MAH) to place the product on the market and ensure sufficient and continuous supply. Three concrete steps may be required: (i) to submit a valid pricing and reimbursement (P&R) application; (ii) to fulfil specific requirements in procurement procedures; and (iii) to establish a rollout plan. Both the company and the Member State must “cooperate in good faith and undertake best efforts to ensure, within the limits of their responsibility, the availability and supply of the medicinal product.”
The PD foresees losses of regulatory protections at national level if launches are not achieved. Where, within three years of such a request, the MAH has not made the product available and ensured continuous supply – within the limits of its responsibilities – this will result in:
- loss of RMP (and, if applicable, the loss of extended orphan exclusivity) in the requesting Member State; and
- the possibility for generic or biosimilar applications to be validated and assessed from year six of the RDP period.
Compared to some of the interim proposals, the final wording, as supported by new Recitals, provides the tools to apply these “obligations to launch” in a reasonable way, and in compliance with the case law of the Court of Justice, which prohibits Member States from forcing companies to sell imported products at a loss, and with Article 16 of the Charter of Fundamental Rights (CFR), which protects the right to conduct a business.
Generally, Member States and MAHs must cooperate in good faith and use best efforts, within the limits of their responsibilities, to ensure availability and supply. A reasonable approach is required. The Recitals of the PR clarify that Member States cannot make impossible demands: launch obligations should not compromise the financial viability of companies and must comply with general EU law, including the principle of proportionality, free movement of goods, and competition law.
In addition, MAHs are not required to comply where exceptional and unforeseeable circumstances, including supply disruptions or duly justified circumstances fully outside the MAH’s control are demonstrated. The scope and practical application of these exceptions remain uncertain and will depend on how strictly Member States interpret both the “best efforts” standard and the notion of circumstances outside the MAH’s control.
The effectiveness of these safeguards in practice remains uncertain and will largely depend on national implementation and enforcement. Time will tell whether the launch obligations will work, as intended, as reasonable best efforts obligations (in French: “obligations de moyen”), to meaningfully engage with Member States. The stakes are high: if Member States would seek to apply the launch obligations as an “obligations de résultat,” the consequences would be severely negative, in particular, in Member States used as reference countries in Most Favored Nation (MFN) comparisons in the United States; see also previous Sidley blogs here and here.
See PD, Article 56a; PR, Recital 11a and Article 5.
3. Expanded Bolar Exception: Tenders and Listings
Under current law, the so-called Bolar exception provides that studies and trials conducted to prepare abbreviated MA applications, and the consequential practical requirements, shall not be regarded by Member States and their courts as infringement of patents or supplementary protection certificates (SPCs).
The compromise text materially expands the Bolar exemption: generic and biosimilar companies can conduct studies, trials, and other activities necessary for obtaining an MA, for conducting health technology assessment (HTA), and for obtaining P&R approval. A key novelty is the possibility for generics and biosimilar companies to submit “an application on procurement tenders”, to the extent that it does not entail the sale or offering for sale or marketing during the protection period provided by patent rights or SPCs. Last but not least, decisions adopted at Member State level concerning HTA, P&R, and tenders shall not be regarded as infringing IP rights.
As argued in a previous Sidley blog and article, the expansion of the Bolar exception raises questions under the WTO´s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). As a minimum, under TRIPS, as well as under Article 51(2) of the CFR, the EU and its Member States must ensure that interference with patent and SPC rights is subject to proper safeguards and is not disproportionate. Patent/SPC holders must also continue to be able to enforce their rights under the Intellectual Property Rights Enforcement Directive (2004/48/EC, IPRED). Three topics will require specific attention in the coming months and years:
- First, Member States are instructed to distinguish between permitted activities before and after “Day 1” of patent or SPC expiry. However, there is currently no EU-level mechanism to determine when Day 1 occurs.
- Second, procedural safeguards and time limits will be needed to prevent the Bolar exception from enabling P&R activities and tenders long before Day 1 (e.g., by national decisions prematurely listing generic or biosimilar products and prices), and also to resolve the inherent tension between the submission of bids prior to Day 1 (which constitute an offer for sale) and the prohibition of “the sale or offering for sale or marketing” prior to Day 1. This tension also applies to P&R procedures, which in many cases involve offers for sale (e.g., managed entry agreements).
- Third, orderly mechanisms will be needed to ensure that IP owners can continue to enforce their rights under IPRED before generic or biosimilar launches. This will require, in particular, clarity on what constitutes “imminent infringement” within the meaning of IPRED.
The Bolar expansion also takes account of an Italian judgment (Boehringer Ingelheim v. Sicor and Teva, Case No 2224/2022) on the role of third-party suppliers: the text clarifies that activities “exclusively” for those purposes may encompass manufacture, sale, supply, storage, import, use, and purchase (including by third-party suppliers/service providers), while still not covering placing the resulting products on the market. This broad functional carve-out further reinforces the need to delineate clearly when preparatory conduct ends and prohibited commercialisation begins.
See PD, Article 85.
4. Orphan Medicinal Products: Losses and Wins
Today, the current baseline protection for orphan medicinal products is effectively about 11 years. Under current law, 10 years of orphan market exclusivity (OME) must pass before authorities can “accept” an application for a similar orphan medicinal product for the same therapeutic indication. The current protection therefore also includes the time between the acceptance of the MA application and its grant, which can be about one year.
The new PR changes the concept of OME: the protection is no longer linked to the acceptance of MA applications for similar products, but to the “grant” of MAs for a similar product. Applications for similar products (including generics, biosimilar, and hybrid applications) can be submitted and assessed within the last two years of OME, and MAs can be granted with suspension until expiration of the OME period. This change reduces the effective OME duration by about one year.
The new PR provides a new baseline with nine years OME for standard orphan medicinal products and 11 years for “breakthrough” orphan medicinal products (i.e., where no authorised medicinal product exists in the condition and it delivers a clinically relevant reduction in morbidity or mortality for the relevant patient population). Therefore, current protection is maintained only for breakthrough products. Finally, the current two-year OME extension for completing a paediatric investigation will be removed and replaced by the six-month extension of the SPC, which was previously only available for non-orphan products.
Under current law, orphan medicinal products may obtain a separate 10-year OME period for each approved orphan indication, allowing for multiple, indication-specific exclusivity periods over time for a single product. However, under the new PR, this approach is replaced by a “global orphan marketing authorisation” (“GOMA”) concept, under which a single OME period applies to the product as a whole, rather than to each individual orphan indication. As a result, orphan medicinal products no longer benefit from separate baseline OME periods for different orphan designations. Instead, an orphan medicinal product may only gain up to two one-year extensions of the initial OME period for additional orphan indications. No such extension is available where the additional orphan indications are authorized within the last two years of the OME period.
Together, these changes mean that companies now have to factor into pipeline management reduced baseline predictability and weakened incentives for multi-indication orphan medicinal product development.
See PD, Article 83(2) and PR, Article 70(1).
5. Pharmacy Compounding and Hospital Exemption: New Battles?
Under current law, pharmacy compounding is a narrow, patient-specific exception to the MA requirement subject to CJEU case law specifying that public health requires exceptions to be interpreted narrowly. Magistral formulas (contemporaneous preparations under doctors’ instructions), officinal formulas (stock preparations made for direct supply to patients of the pharmacy, in accordance with the prescriptions of a pharmacopoeia), and “special needs” supply are built around individual patient needs, not broader supply models. Case law, including recently Almirall (Case C-589/24), confirms that where these conditions are met, such products fall outside the Directive’s scope, leaving Member States with discretion at national level.
The published compromise text both restricts and expands pharmacy compounding. The magistral formula and officinal formula exceptions do not apply to products listed in Annex 2, points 1 and 2 PR (biologics and Advanced Therapy Medicinal Products (ATMPs)).
On the other hand, the PD expands these exceptions in practice, in particular:
- For magistral formulas, Member States may allow advance preparation for up to seven days (or up to three weeks where justified) based on anticipated prescriptions to meet the special needs of individual patients.
- For officinal formulas, Member States may allow a pharmacy to supply “a hospital it serves”, subject to competent authority approval.
In addition, the PD introduces a limited pathway for temporary, potentially population-level supply in justified cases (e.g., shortages or absence of suitable authorised products), subject to safeguards such as prior approval, Good Manufacturing Practice (GMP) compliance, and time limits.
The PD recitals helpfully confirm that pharmacy compounding derogations must not be justified on purely financial grounds and should not distort competition. Given that several Member States currently do justify or even prioritise compounding on purely financial grounds, significant implementation work will be needed in the coming months and years to avoid “replacement” compounding, and ensure compliance with the European Pharmacopoeia requirements (which subject compounding to ethical considerations including an assessment of whether the patient needs can be met by authorized products). For compounding to resolve larger-scale shortages, the PD itself recognises that financial considerations should not lead to recognition of specific needs capable of justifying pharmacy compounding.
For ATMPs, the published compromise text of the PD maintains the hospital exemption, while the broader ATMP framework continues to be governed by Regulation (EC) No 1394/2007. The hospital exemption remains limited to non-routine, patient-specific use within a single Member State, but is now framed more explicitly as a regulated pathway, requiring prior approval by national competent authorities, compliance with GMP and traceability requirements, and the collection and reporting of safety, efficacy, and quality data to national authorities and the EMA. The EMA will establish a repository for such data, and the Commission is empowered to adopt implementing acts specifying key operational aspects, including evidence requirements, data reporting formats, and the conditions for “non-routine” use. Whilst these measures aim to increase consistency and transparency, their practical impact will depend on the forthcoming implementing acts and national practice. Industry will closely watch an EMA report, envisaged by Recital 18 PD, on the assessment of the need for an “adapted framework” for “certain less complex ATMPs”.
Overall, the impact of the new rules on compounding and the hospital exemption for ATMPs will depend on national implementation and enforcement (including compliance with Pharmacopoeia standards and rules), as well as on forthcoming Commission implementing acts. These acts will specify, inter alia, the requirements for hospital exemption applications (including evidence on quality, safety, and efficacy), the content and format for data collection and reporting, the modalities for knowledge exchange between approval holders, and the conditions governing the preparation and use of ATMPs on a non-routine basis.
See PD, Recitals 11 and 18, Articles 1(5)(a), 1(6) and 2.
The new PD introduces a first-in-the-world incentive intended to support innovation in antimicrobial resistance (AMR), alongside a voluntary subscription model intended to help ensure a viable market for such products by the delinkage or partial delinkage of funding from the volume of sales.
At its core, is a transferable voucher for a 12-month extension of RDP for “priority antimicrobials”. To qualify, the product must address a multidrug-resistant organism and demonstrate a significant clinical benefit. The product must either have a mechanism of action distinctly different from that of any authorized antimicrobial, or contain a new active substance that addresses a serious or life-threatening infection. The applicant must also meet certain conditions, including ensuring the demonstration of sufficient capacity to supply, disclosing all direct financial support for research received, and filing in the EU within a defined timeframe.
The voucher may be used either for the antimicrobial itself or transferred for use with another centrally authorized product. However, its use is restricted: where applied to another product, it can only be exercised during the fifth and sixth year of the RDP period and is subject to a gross sales cap of 490 million euros, designed to exclude high-revenue (blockbuster) products.
The scheme is deliberately limited in scope. Only five vouchers will be granted across the EU, they are time limited, and may be revoked if supply obligations are not fulfilled.
Time will tell whether the combination of incentives, restrictions, and subscription models will have a sufficiently stimulating effect to address the high unmet need for new antimicrobials.
See PR, Articles 40-43a.
7. MA Procedures and Paediatric Obligations
The published compromise text includes measures intended to streamline regulatory procedures. Notably, the EMA scientific review timeline is reduced from 210 to 180 days. Several committees of the EMA (the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO), and the Committee for Advanced Therapies (CAT)) will be abolished. Expertise in those areas will be maintained in the form of working groups of the Committee for Medicinal Products for Human Use (CHMP).
For paediatrics, the text is a mixed bag. On the positive side, paediatric investigation plans (PIPs) may in some cases be developed in an “evolutionary” manner, allowing studies to adapt over time as scientific knowledge develops. This can help address the rigidity of the current system in which applicants in some cases need to submit repeated requests to amend PIPs.
By contrast, the text imposes a potentially heavy new burden by restricting the current possibility to waive the obligation to conduct paediatric studies where the disease or condition occurs only in adult populations, or where the product is not expected to represent a significant therapeutic benefit for paediatric patients. Such waivers may not be granted where the product displays a mechanism of action, including where its action is directed at a specific molecular target or biological pathway, that on the basis of existing scientific data is “relevant for a different disease or condition in the same therapeutic area in children” compared to the adult population.
In addition, where a paediatric indication is authorized following completion of a PIP, MAHs will be required to place the product on the market within two years of approval of that indication in all Member States where the product is placed on the market for adult indications, reinforcing obligations on timely launch and availability.
See PD, Recital 76, Articles 30, 59 and PR, Article 75.
8. Environmental Risk Assessment Requirements: New Obligations with Teeth
Under current law, the environmental risk assessment (ERA) is a required component of the marketing authorization dossier, but in practice has often been treated as a relatively contained pre-authorization exercise.
The new PD makes the ERA more than a box‑ticking exercise and turns it into an enforceable life-cycle obligation. Notably, an MA can be refused where the ERA is incomplete, insufficiently substantiated, or where proposed risk mitigation measures do not adequately address identified risks. The ERA must also be kept up to date as new information emerges, including monitoring data and environmental exposure evidence. However, wording was softened from earlier versions of the text, and the national competent authorities and the EMA may convert the ERA requirements into post-authorization obligations. In severe cases, a failure to address environmental risks may lead to withdrawal from the market.
The revised framework also has a retroactive dimension. Medicinal products authorized before October 30, 2005, may be required to submit an ERA under an EMA-led, risk-based programme where they are identified as potentially harmful to the environment.
Overall, the Pharma Package elevates the ERA from a dossier requirement to a continuous compliance obligation, with clearer regulatory consequences and closer alignment with broader environmental and public health objectives, including the EU’s increasing focus on persistent and bioaccumulative substances such as PFAS under parallel regulations (e.g., REACH (Regulation (EC) No 1907/2006)).
See PD, Article 22 and PR, Article 15(1)(d)
9. Monitoring and Management of Shortages and Critical Shortage, and Security of Supply
The compromise text aims to strengthen the EU framework on shortages, with a clearer and more operational focus on obligations for marketing authorization holders (MAHs).
The general supply obligation is clarified and split: MAHs are required to ensure appropriate and continuous supply to distributors and other authorized actors, while distributors are responsible for onward supply. At the same time, notification requirements are expanded and made more stringent. In particular, MAHs must provide early warning of withdrawals, suspensions, and supply disruptions, generally at least six months in advance unless exceptional circumstances apply, and notify shorter-term disruptions without delay.
The regime also shifts toward a more proactive compliance model, with MAHs expected to maintain shortage prevention plans, assess supply chain risks, and implement mitigation measures. At the EU level, the EMA’s role is reinforced, in particular, through the monitoring of critical shortages of Union concern and coordination via the Medicines Shortages Steering Group, which is likely to translate into increased reporting and interaction with authorities.
These measures interact with the proposed Critical Medicines Act (CMA), which, as discussed in our previous Sidley blog, focuses on identifying critical medicines and addressing structural supply dependencies across the EU. While the Pharma Package focuses on regulatory obligations for MAHs, the CMA is expected to add an industrial policy layer aimed at strengthening manufacturing capacity and supply resilience.
The proposal also introduces more interventionist measures, including the possibility for Member States to restrict exports in shortage situations and a voluntary solidarity mechanism for redistribution as a last resort. It further recognizes the impact of parallel trade on shortages, allowing Member States to adopt mitigating measures.
Overall, the changes increase regulatory expectations on supply chain management and will require earlier engagement with authorities, more formalized internal processes, and greater preparedness to justify supply decisions to regulators, particularly in light of the interaction with CMA-related measures for critical medicines.
See PD, Articles 56, 167 and PR, Articles 120, 122, 123, 125a
10. Biotech Act: Additional Changesstrong>
The Commission is advancing a European Biotech Act aimed at strengthening the EU’s biotech competitiveness, including in the health sector, with a focus on regulatory streamlining and accelerating time‑to‑market. The first legislative proposal (Biotech Act I) was published in December 2025 and introduces targeted amendments to existing EU life sciences frameworks. While separate from the Pharma Package, it forms part of the wider EU competitiveness and resilience agenda shaping life sciences investment decisions.
As discussed in our previous Sidley blog, Biotech Act I goes beyond simplification and sets out concrete regulatory and financial measures to incentivize innovation in the EU. These include a substantial overhaul of the Clinical Trials Regulation (e.g., shorter authorization timelines and coordinated assessments), targeted simplifications for ATMPs, particularly at the interface with genetically modified organisms (GMO) and substances of human origin (SoHO) rules, and a more integrated pathway for medicines-device combination products. In addition, the proposal introduces new support mechanisms for biotech companies and new funding and industrial policy tools.
11. Transitional Provisions: Some Clarity (and some questions)
The current legislative regime has governed the authorization and marketing of medicinal products in the EU for more than two decades. The new PD and PR will, for the most part, apply from 24 months after their entry into force, which is 20 days after their publication in the Official Journal of the EU. Despite its pivotal importance for industry and regulators alike, the transitional rules are not straightforward, and the drafting is imprecise in some respects.
Importantly, the existing RDP and RMP periods will continue to apply to medicinal products for which an MA application is submitted before the date on which the new rules apply (i.e., within 24 months after entry into force of the Pharma Package).
Companies should be mindful that applications for new indications for medicinal products authorized under the old PD and PR, but submitted after the date of application of the new PD and PR, will be assessed and granted RMP under the new rules.
| By way of illustration: if the PD and PR are published on December 1, 2026, they will enter into force on December 21, 2026. They will apply as of December 21, 2028.
· A medicinal product, including an orphan medicinal product, with an MA granted prior to December 21, 2026, will maintain its current RDP and RMP. · A medicinal product, including an orphan medicinal product, with an MA application submitted before December 21, 2028, will be assessed under the current PD and PR, and will be rewarded current RDP and RMP. · A medicinal product with an MA application submitted after December 21, 2028, will be assessed under the new PD and PR, and be rewarded new RDP and RMP. · An application for a new therapeutic indication for an existing orphan medicinal product, submitted after December 21, 2028, will be assessed under the new PD and PR rules. Where the conditions are met, the product may benefit from the new additional one-year orphan market exclusivity, which would be added to the existing orphan market exclusivity period. |
An important “early” application applies to Article 56a PD, which, as discussed in Section 2 above, allows Member States to request that products be made available and supplied to meet the needs of their patients. To ensure this tool’s availability as early as possible, the EU lawmakers agreed that Member States may apply Article 56a PD from 12 months after entry into force in respect of medicinal products authorized after the date of entering into force of the PD (and regardless of whether the product was assessed under the existing rules or the new rules).
This early application option has practical implications for medicinal products authorized during the 24-month gap period between entry into force and general date of application. These products in principle remain subject to the existing Directive 2001/83/EC incentive structure. To ensure Article 56a has practical effect during this gap, Article 219(1a) PD provides that, where (i) a product is authorized after the date of entry into force, (ii) a Member State makes a request under Article 56a, and (iii) the MAH fails to make the product available and supply it continuously within three years, then the sanctions set out in Section 2 above may be applied (loss of RMP/extended OME, as well as loss of RDP). For products authorized under the current rules, regulatory market protection under Article 10(1) shall not apply in that Member State.
Next Steps
The legislative process is now in its final stages. Following the political agreement reached in late 2025, the compromise texts were endorsed by the Member States in March 2026 and approved by the European Parliament’s Public Health Committee shortly thereafter. Formal adoption by the Parliament and the Council of the EU is expected in summer 2026, with entry into force following the publication in the Official Journal of the EU expected in the autumn. The new rules will then phase in over time, with full application expected in late 2028.
However, in some respects, the work is only beginning. The Commission and the EMA will need to develop at least 60, and possibly over 100, implementing acts and guidance documents within the two-year transition period. Some of these documents will be crucial in determining the exact impact of the legislation, for example, on defining unmet medical need, or defining the scope of the ATMP hospital exemption. An important missing piece is Annex 1 PD, which will need to replace the current annex, dating from 2003, setting out the requirements for documents and particular supporting MA applications.
The ultimate impact on companies’ rNPV remains to be seen. Baseline protections are reduced, while access, supply, and public health considerations take on a more prominent role. Although certain safeguards have been added during the negotiations, key aspects will ultimately depend on how the new rules are applied in practice, in particular, the scope of “best efforts” obligations and the extent to which Member States make use of the available enforcement tools.
Sidley’s Global Life Sciences team continues to closely monitor the EU Pharmaceutical Package, and we are available to assist companies in anticipating and managing related opportunities and challenges.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
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