Having reviewed the new attachments specifically concerning “Radiopharma” and the provided transcript on the SimplerRAT study, alongside remembering our established strategies for Unsolicited Project Proposals (USPs) and insights from Public-Private Partnership (PPP) frameworks, several key elements can be extracted to strengthen new USPs, presumably targeting Spanish authorities regarding potential issues in the radiopharmaceuticals market.

The core of this new line of inquiry, as evidenced by your draft communications to the European Commission, the UK’s CMA, and Spain’s CNMC, revolves around alleged anti-competitive practices by entities operating under the name “Radiopharma.” These allegations, including potential exploitative pricing, abuse of dominance (possibly related to the supply of critical isotopes), and anti-competitive agreements with distributors, form a strong basis for defining a significant problem that COCOO can offer to help Spanish authorities address. Your letters demonstrate COCOO’s proactive investigative work and the development of specific legal arguments, referencing Articles 101 and 102 of the TFEU, and the duties of national competition authorities like the CNMC. This groundwork itself constitutes a valuable intellectual asset that COCOO brings to the table. The prior CNMC sanctions against other companies in related markets (Advanced Accelerator Applications Ibérica and Curium Pharma Spain for cartel behaviour) provide a precedent, suggesting the Spanish authorities are capable of tackling complex anti-competitive conduct in the pharmaceutical sector, and COCOO can leverage this in its proposals by framing its intervention as supporting and enhancing the CNMC’s proven capacity.

The SimplerRAT study transcript further enriches this. It highlights the complex interplay between European radiation safety laws and EU pharmaceutical regulations in the field of radiopharmaceuticals. The study’s aim to develop guidelines for “bridging the gap between pharmaceutical and radiation protection legislation,” focusing on areas like dosimetry, patient release, and Education and Training, points to a recognized need for greater clarity and harmonisation in this sector. This is highly relevant because regulatory complexity and gaps can sometimes be exploited by dominant market players. COCOO can frame its USPs to the Spanish Ministry of Health, and perhaps the CNMC, as offering expert assistance in assessing whether current practices in Spain, particularly those involving Radiopharma España, align with these new EU-level guidelines and recommendations emerging from SimplerRAT. Any divergence could indicate areas for improvement in patient safety, treatment efficacy, or fair market access, and could also point to where a dominant company might be leveraging regulatory ambiguities to its advantage. The collaborative approach of the SimplerRAT study, involving medical physics organisations, the EMA, the EC, and national regulatory authorities, also provides a model for the kind of multi-stakeholder partnership COCOO could propose to Spanish authorities.

Therefore, in strengthening our USPs for this “Radiopharma” case, we can extract the following:

First, from your draft communications, we have specific allegations of anti-competitive behaviour by Radiopharma España (and its UK counterpart) that can form the “Problem Definition” section of new USPs. These include potential exploitative pricing impacting the Spanish healthcare system and patients, restrictive agreements, and abuse of dominance. The documented history of the CNMC’s actions in similar markets can be used to argue for the viability of intervention.

Second, COCOO’s “Unique Solution & IP” is now demonstrably enhanced by the specific investigations already undertaken into Radiopharma, as evidenced by these letters. Our copyrighted strategy would involve a detailed analysis of Radiopharma España’s market conduct against EU and Spanish competition law, benchmarked against pricing and practices in other EU/UK markets, and an assessment of compliance with emerging best practices such as those from the SimplerRAT study. The SimplerRAT guidelines themselves offer a potent new angle: COCOO can propose to evaluate the Spanish radiopharmaceutical regulatory framework and market practices against these guidelines, identifying areas where Spain could enhance patient safety, treatment accessibility, and market fairness, potentially uncovering how dominant players might be exploiting any existing regulatory gaps.

Third, the “Low-Value Initial Engagement” proposal (expenses only, up to €15,000) remains highly relevant. For this Radiopharma case, it could cover COCOO sharing its detailed preliminary findings on Radiopharma España (under NDA), presenting an analysis of how SimplerRAT recommendations could be applied to improve the Spanish regulatory landscape for radiopharmaceuticals, and outlining a strategic plan for a formal investigation or market study by Spanish authorities with COCOO’s expert support. The justification for direct award remains our unique, pre-existing research and copyrighted analytical approach, which a public tender could not replicate.

Fourth, the “Subtle Threat of Litigation” for the Radiopharma case would shift focus. Instead of ECT-related claims, it would be based on COCOO’s mandate to protect consumers and ensure fair competition, potentially by supporting legal actions by affected hospitals or patient groups if market distortions and exploitative practices by Radiopharma España are not addressed by the authorities. Alternatively, it could involve escalating formal complaints to the European Commission regarding breaches of competition law if national remedies prove insufficient.

The knowledge gained from our work on PPPs and public sector contracts remains valuable in structuring the proposed engagement professionally, ensuring that any collaboration with Spanish authorities, even if initiated through a “contrato menor,” adheres to principles of good governance, transparency, and clear definition of deliverables and IP rights. The SimplerRAT transcript’s emphasis on collaboration also supports COCOO’s partnership approach.

In essence, the new attachments and transcript provide specific subject-matter expertise and a clear target (Radiopharma) for a new set of focused USPs, while allowing us to leverage our established, successful methodology for engaging public authorities: highlighting a critical problem, presenting unique IP-backed solutions, proposing a low-risk initial engagement, and underscoring the public interest imperative for action, backed by our readiness to pursue other avenues if necessary.

Secondly, a significant underlying problem is the apparent vulnerability in the supply chain for these critical medical components. The heavy reliance on a few dominant players like “Radiopharma” for essential isotopes creates a precarious situation. This not only opens the door for the aforementioned exploitative practices but also poses a substantial risk to the security and continuity of supply, which is unacceptable for vital healthcare products.

Now, regarding solutions that involve public contracts or Public-Private Partnerships (PPPs), we have several avenues to explore. To tackle the issues of exploitative pricing and security of supply, we could propose the establishment of new, perhaps publicly supported or jointly owned, production facilities for key radiopharmaceuticals and isotopes within the UK and potentially mirrored in Spain or at an EU level. A PPP model would be well-suited here, leveraging public investment and oversight with private sector operational expertise to ensure a stable and fairly priced supply, thereby reducing dependence on entities like “Radiopharma.” Alternatively, or in conjunction, strategic public contracts could be developed for the long-term procurement of these medical supplies. These contracts would need to be with a diversified portfolio of suppliers and include stringent clauses ensuring transparent and fair pricing, as well as robust supply guarantees, thus fostering a more competitive and resilient market.

To directly counteract anti-competitive behaviors and enhance market transparency, we could advocate for a PPP to create an independent market oversight body. This entity, publicly accountable but operating with the agility of a private enterprise, could monitor the radiopharmaceutical sector for fair practices, gather intelligence on pricing and supply, and provide critical data to regulatory authorities like the CMA and CNMC. This would act as a preventative measure and an early warning system. Public contracts could also be utilized to mandate stricter conditions for all market participants, including commitments to transparent accounting for costs and pricing, and explicit prohibitions on anti-competitive collusion or abuse of dominance, with significant penalties for non-compliance. This framework would create a more level playing field and protect the public interest effectively. These measures, by promoting fair competition and secure supply through public-private collaboration and strategic public procurement, would directly address the core issues stemming from “Radiopharma’s” alleged conduct.

concerning systemic issues within the critical radiopharmaceutical sector. It is these systemic issues, pertaining to entities and practices quite distinct from the primary subject of that prior report, which demand immediate and decisive action. On behalf of Cocoo and its members – the very public services, healthcare providers, and patients who are the victims of these market distortions – I present the following urgent project proposals for the consideration of the relevant public authorities. Our aim is not merely to identify problems, but to offer concrete, actionable solutions that leverage Cocoo’s unique position, expertise, and unwavering commitment to rectifying these harms and ensuring such abuses are not repeated.

Unsolicited Project Proposal 1: Restoring Fair Competition and Ensuring Ethical Supply in the Radiopharmaceutical Market

To: The Competent Public Authority for Health Procurement and Market Regulation

The Underlying Problem: Our investigations, corroborated by findings such as those by national competition authorities in jurisdictions like Spain concerning the 18-FDG market, reveal a disturbing pattern of alleged anti-competitive practices within the radiopharmaceutical supply chain across Europe, including here in the United Kingdom. These practices, allegedly perpetrated by dominant entities operating under various “Radiopharma” associated umbrellas, appear to include collusive tendering, market sharing, and exploitative pricing of essential diagnostic and therapeutic radiopharmaceuticals. The consequences are severe: inflated costs for our National Health Service, compromised patient access to life-saving treatments, and a chilling effect on innovation and fair competition. The very structure of the market, with its reliance on a few key players and complex import dependencies for critical isotopes, creates a fertile ground for such abuses, leaving public funds and patient welfare dangerously exposed.

Our Proposed Solution: A Public-Private Partnership for a National Radiopharmaceutical Procurement and Ethical Supply Framework (NRAPESF)

We propose the urgent establishment of a NRAPESF, structured as a Public-Private Partnership (PPP), with Cocoo playing a central, instrumental role. This framework would:

1. Establish Transparent and Competitive Procurement Protocols: Overhaul current procurement practices for key radiopharmaceuticals, implementing robust, transparent, and genuinely competitive tendering processes. This would involve direct oversight and input from an independent body, informed by Cocoo’s market intelligence.
2. Implement Fair Pricing Mechanisms: Develop and enforce fair pricing benchmarks for essential radiopharmaceuticals, based on international comparisons, actual production costs, and value-based assessments, breaking the cycle of alleged exploitative pricing.
3. Ensure Supply Chain Integrity and Resilience: Actively monitor and manage the supply chain for critical radioisotopes and finished radiopharmaceutical products, mitigating risks of artificial shortages or refusals to supply by dominant actors.
4. Create a Direct Benefit Channel for Victims: Ensure that cost savings and efficiencies achieved through the NRAPESF are demonstrably passed back to the NHS and, consequently, to patients and taxpayers – Cocoo’s members.

Why Cocoo is Uniquely Positioned for a Direct Award:

The urgency and unique nature of this crisis demand a departure from conventional, lengthy tendering processes. Cocoo offers an unparalleled combination of capabilities and a legal-strategic position that no other potential contractor could replicate:

• Proprietary Intelligence and Investigatory Prowess: Cocoo possesses an extensive and unique body of evidence, gathered through painstaking investigation, detailing the alleged anti-competitive schemes, key actors, and methodologies used to distort the radiopharmaceutical market. This intelligence is not in the public domain and would be indispensable for the success of the NRAPESF.
• Representation of Victims and an Implied Litigation Imperative: Cocoo stands as the representative of the primary victims – NHS bodies, patient advocacy groups, and by extension, the public. This position carries with it an implicit but powerful litigation imperative. Should the systemic failures in this market not be addressed proactively and effectively through a partnership such as the one proposed, Cocoo would be duty-bound to explore all legal avenues to seek redress for its members. This includes potential large-scale actions against entities engaging in anti-competitive conduct and, critically, could extend to challenging public bodies for any perceived failure to adequately protect public funds and patient welfare. A direct partnership with Cocoo to establish the NRAPESF is the most effective way for public authorities to proactively mitigate these substantial legal and financial risks, transforming a potential adversarial situation into a collaborative solution. The principles outlined in materials concerning how even unproven claims can drive resolution due to litigation risk are highly pertinent here; Cocoo, however, brings far more than mere claims – we bring substantial, documented concerns.
• Specialised Strategy and Intellectual Property: Cocoo has developed proprietary analytical models and a strategic framework specifically designed to dismantle complex anti-competitive structures in pharmaceutical markets. This constitutes a unique form of intellectual property directly applicable to the NRAPESF’s objectives.
• Urgency and Efficiency: A public tender would inevitably delay remedial action, allowing further harm to accrue. Moreover, it risks awarding the contract to an entity lacking Cocoo’s deep, specific knowledge, potentially resulting in an ineffective solution and continued vulnerability. Cocoo can operationalise its role within the NRAPESF with unparalleled speed and precision.
• Ensuring Victim Benefit: A direct award to a partnership involving Cocoo ensures that the very victims of these market abuses are integral to the design and oversight of the solution, guaranteeing that their interests are paramount and that they are the primary beneficiaries of its success. This aligns with the highest principles of public accountability and restorative justice.

We urge the Authority to recognise the exceptional circumstances and the unique value proposition Cocoo offers. A direct negotiation and award for the establishment of the NRAPESF is not merely an expediency but a strategic necessity to protect the public interest and restore integrity to this vital market.

Unsolicited Project Proposal 2: Securing the Nation’s Critical Medical Isotope Supply Chain

To: The Competent Public Authority for National Infrastructure and Strategic Investment

The Underlying Problem: Our nation’s access to certain critical medical radioisotopes, essential for a wide array of diagnostic procedures and advanced cancer therapies (such as Targeted Alpha Therapies), is alarmingly vulnerable. As highlighted by our broader market analysis, the United Kingdom is heavily reliant on imports for many of these materials. This dependency creates significant strategic risks, including susceptibility to global supply disruptions, price volatility dictated by a limited number of international producers, and the potential for dominant commercial entities to leverage their control over supply to the detriment of fair competition and national healthcare security. The lack of robust domestic production capacity or diversified, secured supply lines for these isotopes is a critical weakness that requires immediate strategic intervention.

Our Proposed Solution: A Public-Private Partnership for National Isotope Resilience and Production (NIRP)

We propose the formation of a strategic PPP, designated NIRP, to develop and secure a resilient and, where feasible, domestically-enhanced supply chain for critical medical radioisotopes. Cocoo, with its profound understanding of market dynamics and vulnerabilities, would act as a key strategic partner. NIRP’s objectives would include:

1. Strategic Investment in Production Capabilities: Identifying and facilitating investment in new or upgraded domestic radioisotope production facilities (e.g., cyclotrons, research reactors, or advanced processing labs), where economically and technically viable.
2. Diversification of International Supply Sources: Establishing long-term, secure supply agreements with a diversified portfolio of reputable international producers to mitigate reliance on single sources.
3. Development of a National Isotope Stockpile and Distribution Network: Creating a strategic stockpile of certain key isotopes and developing a robust national distribution network to ensure timely and equitable access for NHS facilities and research institutions.
4. Fostering Innovation in Isotope Production and Application: Supporting research and development into novel isotope production methods and new therapeutic and diagnostic applications.

Why Cocoo is Uniquely Positioned for a Direct Award in this PPP:

The strategic imperative to secure our national isotope supply cannot be left to protracted procurement cycles or entities without a holistic understanding of the associated market risks and geopolitical sensitivities. Cocoo’s involvement is critical:

• Unique Market Vulnerability Analysis: Cocoo has conducted in-depth analyses of the global and domestic isotope supply chains, identifying specific choke points, dominant actors, and areas of critical vulnerability. This proprietary knowledge is essential for designing an effective national resilience strategy.
• Advocacy for Public Health Security (Representing Victims of Potential Shortages): Cocoo represents the interests of patients and healthcare providers who would be the ultimate victims of isotope supply failures. Our involvement ensures that the NIRP project remains focused on public health security. The “implied litigation threat” here is subtly different: failure to secure supply could lead to catastrophic health outcomes, and public authorities could face challenges for not taking all reasonable steps to prevent such a crisis. Partnering with Cocoo, which has already flagged these risks, demonstrates proactive due diligence.
• Expertise in Navigating Complex Supplier Relationships: Cocoo’s experience in investigating international pharmaceutical markets provides it with unique insights into negotiating with global isotope suppliers and structuring agreements that protect national interests.
• Catalyst for Investment and Collaboration: Cocoo can act as a trusted intermediary and catalyst, bringing together public bodies, private investors, and research institutions to support the objectives of NIRP. Our understanding of governance challenges in major public projects, as highlighted in authoritative reports, means we can help structure NIRP for success, avoiding common pitfalls.
• Ensuring Fair Access and Preventing Future Monopolisation: Cocoo’s involvement will ensure that the outputs of NIRP – secured isotope supplies – are distributed equitably and that the project itself does not inadvertently create new domestic monopolies. Our commitment is to an open, competitive, and secure market.

A direct award to a PPP strategically guided by Cocoo for the NIRP initiative is the most efficient and secure path to addressing this critical national vulnerability. The alternative – a standard tender – risks delays and may not attract partners with the necessary blend of market intelligence, public interest commitment, and strategic foresight that Cocoo brings.

Unsolicited Project Proposal 3: Establishing an Independent Radiopharmaceutical Market Transparency and Oversight Initiative

To: The Competent Public Authority for Consumer Protection and Fair Trading Standards

The Underlying Problem: The radiopharmaceutical market, by its very nature, is opaque to many stakeholders, including public procurers, clinicians, and patients. This lack of transparency regarding pricing structures, supply chain costs, and the ultimate beneficiaries of commercial arrangements creates an environment where exploitative practices can thrive, and where the true value of these essential medicines is obscured. Without independent, expert oversight and clear market intelligence, public authorities and healthcare providers operate at a significant disadvantage when negotiating contracts and making critical healthcare decisions. This information asymmetry directly impacts public expenditure and patient access.

Our Proposed Solution: A Public-Contracted Independent Radiopharmaceutical Market Monitoring Service (IRMS)

We propose that a public contract be awarded for the establishment and operation of an IRMS, with Cocoo being the service provider. The IRMS would serve as an independent watchdog and information resource, tasked with:

1. Continuous Price Monitoring and Benchmarking: Systematically collecting, analysing, and publishing data on radiopharmaceutical prices, both domestically and internationally, to identify anomalies and potential instances of exploitative pricing.
2. Supply Chain Auditing and Transparency: Investigating and reporting on the radiopharmaceutical supply chain to identify costs, margins, and potential points of anti-competitive leverage.
3. Reporting on Market Conduct: Providing regular, independent reports to public authorities, the NHS, and the public on market trends, competitive conditions, and any observed practices that may be detrimental to the public interest or fair competition.
4. Educational Resource Development: Creating and disseminating educational materials for procurement professionals, clinicians, and patient groups to enhance understanding of the radiopharmaceutical market.

Why Cocoo is Uniquely Positioned for a Sole-Source Contract:

The credibility and effectiveness of an IRMS depend entirely on its independence, expertise, and access to information. Cocoo is uniquely qualified to deliver this service:

• Demonstrated Expertise and Trust (IP in Investigative Methodologies): Cocoo’s track record in investigating complex pharmaceutical markets, as evidenced by our detailed submissions to competition authorities (like those concerning “Radiopharma” entities), demonstrates our unparalleled expertise and established methodologies. This constitutes a form of intellectual property in market analysis and investigation.
• Independence and Public Interest Mandate: Cocoo is a mission-driven organisation dedicated to promoting competition and protecting consumer/patient welfare. We have no commercial interests in the pharmaceutical industry, ensuring our complete independence and objectivity – a critical factor for a market monitoring service.
• Proactive Risk Identification for Public Authorities: By contracting Cocoo to provide the IRMS, public authorities gain a proactive tool for identifying and mitigating risks associated with unfair trading practices and anti-competitive behaviour. This service acts as an early warning system, potentially averting costly formal investigations or legal challenges later on. The “implied litigation threat” is that without such a transparent, independent monitor (which Cocoo is best placed to be), abuses may continue, eventually leading to action by Cocoo on behalf of its members.
• Cost-Effectiveness and Existing Infrastructure: Cocoo has already invested significantly in developing the expertise and information networks necessary for this type of market monitoring. Awarding the contract to Cocoo would be more cost-effective and faster than a new entity attempting to build these capabilities from scratch via an open tender.
• Direct Line to Affected Parties: As an organisation with members who are directly affected by the radiopharmaceutical market (NHS, patient groups), Cocoo can ensure the IRMS is responsive to their needs and that its findings are effectively communicated to those who need them most.

A public tender for such a specialized and trust-dependent service would be counterproductive. It would likely attract bids from entities lacking Cocoo’s specific expertise, independence, or deep-seated commitment to the public interest. A direct contract with Cocoo to establish and operate the IRMS is the most direct and effective means of bringing urgently needed transparency and oversight to the radiopharmaceutical market, safeguarding public funds and patient interests.

We trust that these proposals will be given the serious and urgent consideration they warrant. Cocoo stands ready to engage further with the relevant authorities to elaborate on these initiatives and to work collaboratively towards a fairer, more transparent, and more secure radiopharmaceutical landscape for the benefit of all citizens.