Key Points
- The pathway to developing and operating pharmaceutical infrastructure in Ireland is complex. Planning permission granted by the planning authority or An Bord Pleanála ("ABP") and licences issued by the Environmental Protection Agency (the "EPA") are required to build and operate these developments. Currently there are significant delays in planning decisions being issued by ABP as well as EPA licences.
- In addition, we are seeing an increasing number of legal challenges to these grants. The ever-changing European environmental legal landscape also presents additional challenges for developers preparing and submitting consenting applications and the decision makers deciding on the applications.
- Given the complexities in developing pharmaceutical infrastructure in Ireland, there are a number of trends emerging in procurement and contracting strategy aimed at ensuring the process is as streamlined and efficient as possible.
- The delays in the consenting process mentioned above and the recent construction slowdown have led to some delays in transacting land for the development of new pharmaceutical infrastructure and the construction of new facilities. However, existing operators are continuing to invest in the Irish market by acquiring adjacent land for future development and upgrading existing facilities.
Planning
PLANNING PERMISSION AND EPA LICENCES
We are seeing considerable delays in decision-making by planning authorities and the EPA at present. ABP decides ordinary planning appeals and planning applications for strategic infrastructure projects. The main cause of delay is a lack of resources within deciding authorities and administrative difficulty in keeping up with constant changes in EU environmental law requirements. In January 2025, ABP released a statement acknowledging that it has a backlog of cases but stating that it "now has a full complement of members to assist in this (PDF, 103KB)." While this is positive, we are yet to see the backlog cleared and ABP finding its way to continually issuing decisions in a quick turnaround time.
With limited exceptions, planning decisions must comply with Ireland's climate obligations. This requirement was heightened this year in Coolglass Wind Farm Limited v An Bord Pleanála [2025] IEHC 1. While the decision is under appeal, it is clear in any event that any application for infrastructure development will have to address ABP's climate obligations under section 15 of the Climate Action and Low Carbon Development Act 2015, as amended (the "Climate Act").
INCREASED LITIGATION
Planning permission and EPA licences are frequently subject to judicial review challenges by third parties. Judicial reviews against ABP decisions increased by 67% from 2023 levels in 2024.
ONE TO TRACK:
Friends of the Irish Environment CLG ("FOIE") has issued proceedings in relation to decisions made by the EPA in the course of granting a revised Industrial Emissions Licence to a pharmaceutical company. During the licence review process, the EPA found that the identities of certain raw materials were confidential and did not have to be disclosed to the public, as the related environmental properties were fully disclosed and made available for public consideration. FOIE objected to this. The case is likely to be heard in Q4 2025. Any company that has made an application or is considering making an application should consider its strategy in how to address potential outcomes of this case.
Environment
URBAN WASTEWATER TREATMENT DIRECTIVE ("UWWTD")
The UWWTD was published in the Official Journal on 12 December 2024. It must be transposed by 31 July 2027. The directive lays down rules on the collection, treatment and discharge of urban wastewater. It requires Member States to progressively introduce a "quaternary treatment" to remove micropollutants from urban wastewater. It also introduces new extended producer responsibility obligations for producers of in-scope products, including certain medicinal products for human use and certain cosmetic products.
By 31 December 2028, in-scope pharmaceutical and cosmetics producers will be obliged to contribute a minimum of 80% of the additional costs for quaternary treatment. This includes investment, operational and monitoring costs. In-scope producers will also be required to pay for gathering and verifying data on products placed on the market.
An exemption from the scheme is available for producers placing below one tonne of in-scope substances on the market per year, and for producers who can demonstrate that the substances contained in their products are rapidly biodegradable in wastewater or do not generate micropollutants in wastewater at the end of their life. The European Commission is empowered to adopt implementing acts by the end of 2027 to establish detailed criteria to identify these exempted products.
The European Federation of Pharmaceutical Industries and Associations ("EFPIA") has taken a challenge against the UWWTD before the European General Court. The EFPIA argues that the decision to hold only the pharmaceutical and cosmetics industries responsible for the costs of water treatment is unfair and contrary to key principles of EU Treaties.
PFAS
The use of PFAS chemicals (per- and polyfluoroalkyl substances) came under increased regulatory scrutiny in Europe over the course of the last year. In September 2024, the European Commission adopted new measures under REACH (EU chemicals legislation) to restrict the use of certain PFAS. The new rules will come into force on a staggered basis from April 2026. Particular uses of the restricted substances are not affected, including in certain categories of medical devices.
The use of PFOS and PFOA, other PFAS-subgroups, is already restricted in the EU. Time-limited exemptions exist for some specific uses of PFOA, including in invasive and implantable medical devices. Additionally, the European Chemicals Agency is considering a proposal to introduce a general restriction of all PFAS under the REACH Regulation. A time-limited derogation is proposed for medical devices, due to lack of feasible alternatives.
Construction
"Master agreements are increasingly drafted in a way which allows them to be utilised across multiple jurisdictions."
Considering the challenges with the planning process, as outlined above, procurement and contracting strategies for pharmaceutical infrastructure development are increasingly focused on approaches that allow for maximum efficiency. In recent years, appointing contractors under the terms of a master agreement has become prevalent in the sector. The use of master agreements allows developers/operators to engage in a single set of contract negotiations with a contractor and thereafter use the agreed terms across various projects as they arise (including greenfield/brownfield construction, refurbishment and retrofitting projects).
In addition, master agreements are increasingly drafted in a way which allows them to be utilised across multiple jurisdictions (again, ensuring a streamlined contracting process and driving continuity for both developers/operators and contractors). This is generally achieved by drafting master agreements in terms which are not jurisdiction-specific and providing a country-specific addendum for each jurisdiction in which the master agreement will be utilised.
DATE TO NOTE:
By 31 December 2028, in-scope pharmaceutical and cosmetic producers will be obliged to contribute a minimum of 80% of the additional costs for the quaternary treatment.
Real Estate
"The recent slowdown in construction activity has also curbed some pharmaceutical development. The impact of the above has led to increased interest in ready-to-go pharmaceutical facilities."
The delays in the consenting process mentioned above have led to delays in the bringing to market of land for the development of new pharmaceutical infrastructure. These delays also impact the conveyancing timeline for the acquisition of such land, particularly where the sale/purchase contract between the landowner and purchaser/developer is conditional on the granting of such consents. The recent slowdown in construction activity has also curbed some pharmaceutical development. The impact of the above has led to increased interest in ready-to-go pharmaceutical facilities, i.e. those which have already been completed, and which are available to acquire.
Despite the issues with the consenting process, the construction slowdown and other macroeconomic factors, we are seeing key pharmaceutical clients doubling down in Ireland, which is positive. Some existing operators have acquired planning permission for extensions to existing facilities, have acquired land for future expansion or have entered into option agreements with landowners, with a view to exercising the option to purchase the relevant land as and when expansion plans are implemented. We are also seeing some clients review their energy requirements and adding electricity generation capacity on-site. This demonstrates a willingness on the part of key pharmaceutical clients to continue to invest and re-invest in Ireland.
What's Next?
Recast Energy Performance of Buildings Directive
This Directive aims to reduce greenhouse gas emissions from buildings and improve their energy performance. It obliges Member States to put mechanisms in place so that, from 2030, all new buildings are zero-emission buildings with a view to achieving a zero-emission building stock by 2050. The Directive also sets minimum energy performance standards for non-residential buildings by ensuring they do not exceed maximum energy usage thresholds, to achieve a gradual phase-out of the worst performing buildings. The Directive will have significant implications for developers and operators of new and existing pharmaceutical facilities, who now have a clearer line of sight of the obligations to be transposed in Irish law, and who will wish to factor these into development and expansion strategies. You can read more in our briefing here: How to get a Net-Zero Building Stock: Q&As on the Recast Energy Performance of Buildings Directive
Planning and Development Act 2024 (the "2024 Act")
The 2024 Act will repeal and replace the Planning and Development Act 2000 when it is commenced in phases over the course of 2025 and potentially 2026. Alongside accompanying regulations which are yet to be published, the 2024 Act will have a major impact on the Irish planning regime. Forthcoming provisions to note include:
- The introduction of mandatory decision-making timelines for planning applications;
- Significant amendments to the process for alteration and extension of duration applications. Non-material alteration requests must be granted, while material alteration or extension requests will enter a process that is akin to making a new planning application;
- In a judicial review, the statement of grounds may only be amended if there is good and sufficient reason for the amendment and the failure to rely on the amended grounds originally was outside the control of the applicant and their legal advisors;
- The introduction of a new option for developers to suspend the duration of their planning permission during a judicial review;
- A new High Court power to order decision makers to correct errors in decisions under certain circumstances, rather than quashing a permission; and
- The introduction of cost-capping and an "environmental legal costs financial assistance mechanism" from which unsuccessful applicants can apply to recover costs.
Noting that planning decisions must now comply with Ireland's climate obligations, we expect earlier engagement on both procurement of construction materials and design will become a feature going forwards.
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.
