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The importance of environmental sustainability in the pharmaceutical industry cannot be overstated. As the industry continues to grow, its environmental footprint also expands, contributing to pollution and resource depletion.

From the raw material extraction, to manufacturing processes, global distribution, and eventual disposal⁶, the pharmaceutical industry is responsible for generating approximately 52 megatons of CO2⁷ annually – an amount exceeding the emissions of the automotive sector in nations like the UK.

As concerns about climate change, ecosystem protection, and human health continue to rise, numerous frameworks have highlighted the numerous frameworks have highlighted the need to address the environmental impact of the healthcare sector, including the Paris Agreement8, the UN’s Sustainable Development Goals (SDG)⁹, and the Greenhouse Gas Protocol¹⁰.

B The Corporate Sustainability Due Diligence Directive (CSDDD) applies to large EU limited liability companies and partnerships, encompassing approximately 6,000 companies with more than 1,000 employees and a net turnover exceeding EUR 450 million worldwide. For large nonEU companies, around 900 entities with a net turnover of more than EUR 450 million within the EU are included. The Directive includes provisions to facilitate compliance and limit the burden on companies, both in scope and within the value chain. Micro companies and SMEs are not directly covered by the proposed rules, but the Directive provides supporting and protective measures for SMEs that might be indirectly affected as business partners in value chains.

In the EU, the European Commission has been actively developing plans and roadmaps to establish environmental sustainability criteria in healthcare tenders. Some key initiatives and frameworks include:

The European Green Deal, introduced in 2019, aims to transform the EU into a sustainable, climate-neutral economy by 2050. The Green Deal emphasizes the importance of creating sustainable healthcare systems that not only protect human health but also the environment. This include promoting the use of safer chemicals, reducing pharmaceutical pollution, and ensuring sustainable procurement practices.^{11, 12}
The Corporate Sustainability Due Diligence Directive (CSDDD) mandates that companies identify, mitigate, and transparently report on environmental impacts throughout their operations and value chains. To comply with the CSDDDB, companies will need to invest in sustainability initiatives such as adopting green technologies, improving energy efficiency, and ensuring sustainable procurement practices. This directive encourages collaboration between companies, governments, and other stakeholders to develop innovative and responsible solutions to address their environmental impact.¹³
The Circular Economy Action plan, which aims to promote sustainable resource use and reduce waste, encourages pharma companies to adopt eco-design principles such as creating products that are easier to recycle, designing products for longer use, and using secondary raw materials. ^14,15
Across Europe, several countries have also started developing their own sustainability initiatives, focusing on the impact of procurement/tendering and health technology assessments, and how to contribute to the United Nation’s Sustainable Development Goals.

FIGURE 10

European countries with sustainability initiatives Adapted from HPR195 Assessing the Adoption of Sustainability Criteria Within National Healthcare Procurement Policies in Europe

When analysing the main criteria in MEAT tenders, a combination of factors beyond price are used to evaluate tenders.

FIGURE 8

Annual cumulative % of occurrence and average weighting of criteria used in awarded batches of top biosimilars' tenders since 2021

When analysing the data for the average weighting of the criteria used in awarded lots (Fig. 9), terms and conditions have now become the most recurrent criteria used, right after price.

Due to the supply and logistics issues caused by the Covid-19 pandemic plus some major stock-outs, also for Biosimilars, the importance of logistics, delivery, and supply in healthcare tendering has significantly increased5. Avoiding shortages of essential medicines and maintaining availability of supply to ensure treatment of critical populations continues to be paramount to patients’ health and to keep hospitals working smoothly.

Some other criteria, however, have seen a decline in importance. Packaging, quality, product technical features, and safety have all had a slight decrease in relevance as awarding criteria. Not surprisingly, social and environmental sustainability has shown a relative growth in importance since 2021.

FIGURE 9

Year on year trend of % average weighting of different criteria used in awarded batches of top biosimilars' tenders since 2021

Cube RM’s analysis of 16,845 awarded batches of top biosimilars across all European countries since 2021, conducted using proprietary and tender-specific, AI-based search algorithms that crawl multiple online tender sources worldwide, provides further evidence of these trends.

The data visualized within the Cube RM platform shows that price continues to be the most important criteria when awarding tenders. However, some evolution towards tender sustainability can be observed. For instance, when examining the use of price-only versus MEAT criteria by country cluster, some interesting patterns emerge.

Annual MEAT vs Price-Only Top Biosimilars' Tenders in European Countries since 2021 Aggregated by Cluster

Countries were divided in clusters based on market strategy, i.e. which markets are prioritized in a company’s launching strategy. Cluster 1: Germany, France, Italy, Spain, and UK; Cluster 2: Denmark, Finland, Iceland, Norway, and Sweden; Cluster3: Czechia, Belgium, Ireland, Poland, and Portugal; Cluster 4: Bulgaria, Croatia, Cyprus, Estonia, Hungary, Latvia, Lithuania, Luxembourg, Malta, Romania, Slovenia, and Slovakia.

Cluster 1
In Germany, France, the UK, Italy, and Spain, MEAT criteria are becoming increasingly important in tendering processes.

Cluster 2
In Denmark, Finland, Iceland, Norway, and Sweden, MEAT represents now the main tendering practice.

Cluster 3
In Czechia, Belgium, Ireland, Poland, and Portugal, some tenders are starting to follow MEAT criteria, however price-only tenders continue to be the norm.

Cluster 4
In Bulgaria, Croatia, Cyprus, Estonia, Hungary, Latvia, Lithuania, Luxembourg, Malta, Romania, Slovenia, and Slovakia, price-only tenders also continue to represent the majority of cases.

In Focus

Germany for many years, was a typical ‘price-only’ country, driven by big national insurance tenders. However, due to recent supply challenges and shortages, we can observe an inclusion of supply-criteria in tenders in 2024.

Annual MEAT vs Price-Only Top Biosimilars' Tenders in Germany since 2021

Examples of extracted award criteria for supply in Germany

For public authorities and purchasers in the healthcare sector, the increasing availability of generic and biosimilar alternatives has made tendering an effective way to lower prices and increase patient access to treatments, while keeping healthcare expenditure under control. For companies, tendering can break monopolies by fostering open competition and equal opportunities, while also increasing transparency through public announcements and clear selection criteria.

However, traditional tendering practices with “winner takes all” and “price-only” scenarios often result in negative outcomes:

In France, for example, a “winner takes all” approach led to product withdrawals from the market. Over time, some medicine classes had only one alternative available, causing shortages when supply quotas couldn’t be met.
When “price-only” criteria are used, pharmaceutical companies tend to resort to aggressive price-cutting behaviours driven by market share and sales priorities, further perpetuating price erosion in the pharmaceutical tendering market. The significant profit loss associated with the resulting price erosion can make commercialization unattractive, reducing supplier numbers and potentially increasing prices and shortages in the long term, effectively re-establishing a monopolization of the market.

In recent years, efforts to transform tendering into a more sustainable practice have led to various actions. These include reducing administrative burdens through pre-qualifications and electronic bidding systems, splitting contracts to minimize shortages, and awarding contracts based on criteria beyond price, such as supply and logistics, and environmental sustainability.

The European Commission conducted an online survey involving various stakeholders, such as national authorities for medicine pricing and reimbursement, public procurers, payers, pharmacists, patient representatives, and representatives from the pharmaceutical industry and wholesalers. The survey explored how specific PPM practices and procedures affect different policy goals.

Among the 58 participants, MEAT (Most Economically Advantageous Tender practices were ranked as the most important for achieving affordability, competition, and supply security. Stakeholders also highlighted that, similar to ensuring supply security, procurers might need to balance different policy objectives. Specifically, incorporating environmental criteria in procurement could lead to higher prices and/or reduced competition.

Average importance of PPM award criteria by policy objective Adapted from the European Commission Study on Best Practices in the Public Procurement of Medicines: Final Report

Ideally, depending on local policies and ambitions, different award criteria and tender practices should be given priority, reflecting a more balanced and holistic approach to procurement.

https://www.who.int/health-topics/healthtechnology-assessment#tab=tab_1
https://www.abpi.org.uk/partnerships/workingwith-patient-organisations/workingwith patientsand-patientorganisations -2022-sourcebook-forindustry/definitionsof-participants/#:~:text=The%20European%20Patients’%20Academy%20on, of%20living%20with%20a%20disease

About the author

Stephen Hall

Director

Stephen joined Valid Insight in 2019 and currently holds the position of Associate Director.

Before this, Stephen earned a PhD in Neuropharmacology, worked as a postdoctoral researcher in Neuroscience, and then joined the Wellcome Trust as a researcher. Here, his research focused on unraveling the disease pathologies of various neurological conditions. He has won several awards for his research, presented at prestigious conferences and published in high-impact journals. More recently, Stephen worked at the NHIR, writing documentation for health technology submissions to NICE and working closely with the topic selection group to communicate the complex details of health technology assessments. Stephen’s multifaceted background and accomplishments in academia, research, and healthcare make him a valuable asset to Valid Insight.

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To find out more about how Valid Insight can support you in optimising tender strategy, please reach out to discover@bioscriptgroup.com

2025 presents the EU with an impending transformation — the implementation of the JCA process across all 27 member states. This harmonisation offers a remarkable opportunity to integrate patients and patient organisations into the JCA framework, not just as participants but as active collaborators in healthcare decision-making.

To leverage this opportunity to optimise patient engagement effectively, three key areas call for strategic consideration:

Empowering patients through education and resources:
- Comprehensive training programs: Develop tailored educational initiatives to demystify the HTA process for patients.
- Interactive workshops: Organise hands-on sessions to equip patients with the skills to contribute effectively.
Forging early collaborations with patients in product development:
- Uncovering real-world needs: Involve patients at the earliest stages of product development to gain invaluable insights into their experiences and steer innovation accordingly.
- Shaping value propositions: Align product profiles with patient preferences to address unmet patient needs and create compelling value propositions.
Ensuring transparency, impact and clarifying the role of patient voices:
- Establishing funding mechanisms: Offer compensation for patient contributions to foster equitable involvement and mitigate financial barriers.
- Communicating clearly: Articulate how patient input will be utilised and its influence on outcomes to build trust and ensure meaningful participation.
- Implementing feedback loops: Create channels for patients to voice their perspectives on the process and its efficacy to drive continuous improvement.

By addressing these strategic considerations, healthcare stakeholders can foster meaningful patient involvement in HTAs, leading to more patient-centric healthcare decisions, improved outcomes, and a healthcare system that truly reflects the needs and values of the patients it serves.

As the EU moves towards the standardisation of the JCA process, it is crucial to ensure that patients and patient organisations are actively involved as co-architects of healthcare decision-making. Valid Insight stands ready to be your partner in navigating market access and patient engagement within the HTA and JCA processes.

Despite the widespread recognition of the importance of patient involvement in HTA, there is a lack of consensus on how to assess the quality of patient involvement.

Observing guidelines provides a systematic approach to assessing the quality of patient involvement in HTAs based on the following principles:

Transparency: The process of patient involvement should be transparent, with clear and accessible information about how patients are involved, what their role is, and how their input is used.
Accountability: Patients and patient organisations should assume responsibility for their involvement in HTAs, and mechanisms should be established to ensure accountability.
Inclusiveness: Efforts must be made to ensure that individuals from diverse backgrounds and with different experiences are involved.
Impact: Patient involvement should have a meaningful impact on the HTA process and the resulting decisions. This can be assessed by examining factors such as the degree of patient input reflected in the HTA report and the influence of patient involvement on the decision-making process.
Capacity building: Organisations representing patients and patient advocates should have the capacity to participate effectively in HTAs. This includes having the necessary skills, knowledge, and resources.
Sustainability: The involvement of patients in these processes should be sustainable, with mechanisms in place to ensure that they continue over time.

Ensuring high-quality patient engagement requires adhering to specific criteria and skills, where a transparent and meritbased selection process is crucial to identifying suitable patient advocates. Patient organisations often face resource constraints, emphasising the need for accessible training and support. Collaborative efforts can help bridge the resource gap and empower patient advocates to participate effectively in the JCA framework.

On May 23, 2024, the European Commission (EC) adopted the updated Implementing Act (IA) on JCA, heralding a major shift in the EU’s clinical assessment of oncology drugs, advanced therapy medicinal products (ATMPs), and medical devices.

This framework aims to standardise clinical assessment across 27 EU member states, ensuring a more consistent approach to decision-making.

A key aspect of JCA is its focus on patient involvement, which has long been a critical but often overlooked component of healthcare decision-making. The framework seeks to integrate patient perspectives into the HTA process, recognising that patients have valuable insights and experiences that can contribute to better healthcare decisions.

Steps to improving patient involvement in the JCA process

The Implementing Act on JCA is a significant step in the right direction by involving patients and patient advocacy groups from the outset, beginning with the assessment of PICO (Population, Intervention, Comparator, Outcome) and extending to the evaluation of the final JCA dossier.

Patients will be involved in two steps of the JCA process:

Preparing PICO-S: PICO is a framework used to formulate research questions in healthcare, while PICO-S includes Scope in addition to the usual PICO components. Patients will contribute to developing the scoping document, which will be sent to member states for feedback and acceptance.
Evaluating the JCA dossier: Patients will have the opportunity to evaluate the approved JCA dossier, ensuring the consideration of patient perspectives in the decision-making process.

The JCA framework is expected to have a significant impact across the pharmaceutical industry, with companies now needing to consider patient involvement early in the HTA evaluation process. Industry understanding of the changes introduced by JCA will be critical to quelling uncertainties and ensuring success following its implementation.

Patient involvement in clinical assessment is crucial because it brings a unique perspective to the decision-making process. The firsthand experience of living with a condition enables patients to provide valuable insights into the effectiveness, safety, and overall impact of treatments. By incorporating these perspectives, healthcare professionals and policymakers can make more informed decisions that better address patients’ needs and improve healthcare outcomes.

Concerns and challenges in JCA implementation

The JCA framework is a positive step towards ensuring that patients are heard, and their voices are taken into account in healthcare decision-making. However, there are concerns that the JCA process could be risky in terms of patient advocacy groups’ capacity to engage effectively. It is essential to have good representation at the national level to ensure that patient voices are not lost in the process.

Additionally, there is a paradox that the more frequent a disease, the stronger the voice, highlighting the challenge for smaller patient groups, particularly those representing rare diseases. While large organisations have the capacity to understand the JCA process, it could be challenging for smaller patient groups to participate. It is important to emphasise the significance of organisations representing rare diseases, as there can be a knowledge barrier among decision-makers on these conditions.

The successful implementation of the JCA framework faces challenges. For example, patients may find the process complicated, and some may lack the requisite technical knowledge to participate effectively. Addressing these hurdles requires a careful evaluation of patient involvement’s quality, including the patient organisation’s role.

All stakeholders must work together to ensure that patient involvement in clinical assessment is meaningful and sustainable, leading to better healthcare outcomes for all.

Across Europe, the landscape of patient involvement in the HTA processes is fragmented with significant variation in the level of patient involvement and an absence of common rules across countries.

Several countries have made significant progress in integrating patient perspectives into their decision-making frameworks. However, in other countries, patients are only involved in a limited number of HTA processes, their involvement is not meaningful, or they are not involved at all.

AThe National Institute for Health and Care Excellence (NICE) in the UK was the first HTA body to introduce standardised patient engagement. NICE has a well established process for involving patients in all stages of the HTA process, from scoping to appraisal. Other countries, such as Sweden, Norway, and Denmark, have also developed formal processes
for patient involvement in HTAs.

The discussion of patient involvement in HTAs in Europe would be incomplete without acknowledging the challenges and opportunities associated with it. While there is a growing recognition of the importance of patient involvement, several challenges hinder its effective implementation. However, there are also emerging opportunities that can drive improvements in patient involvement.

Challenges

There are several challenges to improving patient involvement in HTAs in Europe. These include:

Lack of a standardised approach
There is no standardised approach to patient involvement in HTAs across Europe. This makes it difficult for patients to participate effectively in the HTA process and for HTA bodies to ensure that patient perspectives are taken into account in decisionmaking. This represents a major barrier to equitable access to healthcare, as patients from different countries with the same disease may have different opportunities to be involved in the decision-making process.

Lack of transparency
In many countries, the process for involving patients in HTAs is not transparent. This can make it difficult for patients to understand how they can participate and how their input will be used.

Lack of resources
Many patient organisations do not have the resources to participate effectively in the HTA process. This can make it difficult for them to collect and analyse data, develop evidencebased positions, and engage with HTA bodies.

Lack of time
The HTA process is often very timeconsuming. This can make it difficult for patients to participate, especially if they are also dealing with a serious illness.

Opportunities

Despite the challenges, there are also several opportunities to improve patient involvement in HTAs in Europe. These include:

The increasing recognition of the importance of patient involvement
There is a growing recognition among policymakers, HTA bodies, and patient organisations of the importance of patient involvement in HTAs. This is creating momentum for change.

The development of new tools and resources
New tools and resources are being developed to support patient involvement in HTAs. These include guides, toolkits, and training programs.

The increasing use of patient-reported outcomes (PROs)
PROs are increasingly being used in HTAs to measure the impact of health technologies
on patients. This is giving patients a more direct voice in the HTA process.

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