17DEC ESP RADIOFARMA

20DEC
BAS

Report on Judicial Review Opportunities Re: Radiofarma Case

Date: December 21, 2025

To: COCOO / Legal Strategy Team

From: Gemini (AI Legal Assistant)

Subject: Custom Balancing Act Report on JR Opportunities (Radiofarma)

This report outlines potential Judicial Review (JR) opportunities arising from the current situation involving Radiapharma (Radiofarma), the regulatory actions by the CNMC (Spain) and CMA (UK), and the procurement practices of public health bodies. The analysis assumes Spanish law is substantially the same as UK law regarding these principles, as instructed. The report applies the legal concepts of Wider Public Interest (WPI) versus Economic Efficiency (EE) and utilizes the provided file definitions of Market Power (MAP) and Monopoly Power (MOP).

EXECUTIVE SUMMARY

The radio-pharmaceutical sector, specifically regarding 177Lu-PSMA-617 and other isotopes, exhibits characteristics of market failure due to high barriers to entry and regulatory capture. The recent events, including the CNMC’s prohibition of the Curium/IRAB merger and the allegations of excessive pricing (98% premium), present distinct opportunities for legal challenge. The core tension lies between the regulators’ tendency to focus on narrow economic efficiency (EE) and the broader public interest (WPI) goals such as public health, patient access, and fiscal responsibility.

JR OPPORTUNITY 1: CHALLENGE AGAINST PUBLIC PROCUREMENT DECISIONS (REGIONAL HEALTH SERVICES / HOSPITALS)

Parties:

Claimant: Patient Advocacy Groups (e.g., COCOO, AECC), Competitors (excluded suppliers).

Defendant: Regional Health Services (e.g., SAS, CatSalut) or specific NHS Trusts.

The Context:

Public hospitals and health services have allegedly awarded contracts to Radiapharma (Curium/Novartis entities) without competitive tenders or under conditions that favor the incumbent. Evidence suggests a 98% cost premium for 177Lu-PSMA-617 in the UK compared to the EU, and single-bidder awards in Spain.

Grounds for Review:

  1. Illegality and Breach of Procurement Rules: Public bodies are acting as undertakings when purchasing goods if they participate in the market. If they fail to undertake open competitive procurement for non-economic goods, or if the process is designed to exclude rivals, this is unlawful.

  2. Failure to Consider WPI (Public Health and Cost): The decision-makers failed to take into account relevant material considerations, namely the impact of excessive pricing on patient access and the efficient allocation of public funds.

  3. State Aid / Unlawful Subsidy: Overpaying for radiopharmaceuticals constitutes a transfer of state resources to a private entity, which may be classified as illegal State Aid if it provides a selective advantage.

The Balancing Act (EE vs WPI):

The defendants will argue based on Economic Efficiency (EE) and security of supply. They will claim that Radiapharma is the only reliable supplier and that direct awards ensure continuity of care, which is a legitimate objective. They may argue that competition would disrupt the supply chain of critical isotopes.

However, the WPI argument is stronger. The excessive cost (98% premium) harms consumers (patients) by reducing the volume of treatments available within a fixed budget. The lack of competition is not “natural” but arguably constructed through exclusionary practices (MOP). The court must weigh the administrative convenience of the public body against the severe WPI harm (reduced patient welfare and fiscal waste). A challenge here seeks to enforce the duty of public bodies to foster competitive markets rather than entrenching a monopoly.

JR OPPORTUNITY 2: CHALLENGE AGAINST THE REGULATOR (CNMC) FOR INSUFFICIENT REMEDIES OR FAILURE TO ACT

Parties:

Claimant: COCOO, Competitors, or Consumer Associations.

Defendant: CNMC (National Commission on Markets and Competition).

The Context:

While the CNMC recently prohibited the Curium/IRAB merger (October 2025), claimants may argue this action is insufficient to address the ongoing abuse of dominance (excessive pricing) or that previous sanctions (2021) were not rigorous enough to change behavior. If the CNMC fails to open a new investigation into the 177Lu-PSMA-617 pricing despite evidence, this “failure to act” or “decision not to investigate” is challengeable.

Grounds for Review:

  1. Failure to Act / Failure to Investigate: A decision not to initiate an investigation or to terminate one without measures can be challenged. If the CNMC ignores evidence of “exploitative pricing” (a form of Abuse of Dominance under Article 102 TFEU), they are failing their statutory duty to protect the public from anti-competitive conduct.

  2. Manifest Error of Appraisal: If the Regulator accepts the incumbent’s justification for high prices (e.g., R&D costs) without sufficient scrutiny of the actual costs vs. premiums (98% difference), this constitutes a manifest error.

  3. Regulatory Capture: The claimants can argue that the regulator has become “captured” by the industry, accepting the status quo of high prices to ensure “stability” at the expense of competition.

The Balancing Act (EE vs WPI):

The Regulator will defend its position by citing its broad discretion in complex economic assessments. They may argue that price regulation suppresses innovation (an EE goal) and that they must balance “security of supply” with competition.

The Counter-Argument (WPI) is that the regulator’s discretion is not absolute. They have a duty to ensure that market power is not abused to harm consumers. The “security of supply” argument fails if the incumbent is artificially restricting output or raising rivals’ costs (Bainian market power). The WPI goal of Public Health (Article 168 TFEU) requires that competition law be applied to ensure affordable access to medicines. The court should favor a stricter standard of review where fundamental rights (health) are at stake.

JR OPPORTUNITY 3: INTERVENTION IN MERGER APPEALS OR NEW MERGER CHALLENGES

Parties:

Claimant: Third Party Interveners (Competitors/COCOO).

Defendant: The Competition Appeal Tribunal (CAT) or Spanish Courts reviewing CNMC decisions.

The Context:

If Radiapharma appeals the CNMC’s prohibition of the Curium/IRAB merger, third parties must intervene to support the prohibition. Alternatively, if a new consolidation attempt occurs (e.g., “Stealth Consolidation”), a JR can be launched against the clearance of such transactions.

Grounds for Review:

  1. Significant Impediment to Effective Competition (SIEC): The merger would strengthen a dominant position, allowing the entity to raise prices or exclude rivals.

  2. WPI Grounds – Public Health and Industrial Policy: The merger threatens the “plurality” of the supply chain, creating a single point of failure for national health infrastructure.

  3. Procedural Impropriety: If the regulator fails to grant third parties (like COCOO) access to the file or the right to be heard during the merger review, this is a breach of procedural rights.

The Balancing Act (EE vs WPI):

The merging parties will argue an “Efficiency Defence” (ED), claiming the merger creates economies of scale that benefit consumers. They may also invoke “Industrial Policy” to create a “National Champion” capable of competing globally.

The WPI Rebuttal is that creating a “National Champion” often results in domestic monopolies that harm local consumers. The court must balance the theoretical efficiency gains against the concrete harm of reduced choice and higher prices (WPI). Evidence of past cartel behavior (2021 sanctions) strengthens the argument that any increase in market power will be abused (MOP).

JR OPPORTUNITY 4: CHALLENGE AGAINST REFUSAL TO GRANT COMPULSORY LICENSING OR SUPPLY

Parties:

Claimant: Generic Manufacturers or Radiopharmacies.

Defendant: Patent Office or Regulator.

The Context:

If Radiapharma refuses to supply isotopes or uses patent thickets to block generic entry of 177Lu-PSMA.

Grounds for Review:

  1. Abuse of Dominance (Refusal to Supply): A dominant firm restricting output or access to an essential facility (isotopes) to exclude competition is a violation.

  2. WPI Exception to IPRs: Intellectual Property Rights are not absolute. Exemptions should be removed if they are used to abuse market power (ADP).

The Balancing Act (EE vs WPI):

The incumbent will argue for the sanctity of IPRs to incentivize R&D (EE).

The WPI argument is that “innovation” is not served by blocking competitors. Public Health (WPI) overrides the strict enforcement of IPRs where there is a failure of supply or excessive pricing. The court can order a compulsory license or remedy to unlock the market.

CONCLUSION

The strongest JR opportunity lies in challenging the procurement decisions of health bodies (Opportunity 1) and the potential inaction of the regulator regarding pricing abuses (Opportunity 2). The legal framework supports a shift from pure “economic efficiency” to a broader “consumer welfare” and “public interest” test. By framing the high cost of Radiopharmaceuticals not just as a commercial issue but as a Public Health WPI crisis, the claimants can leverage the court’s duty to protect the public from the abuse of monopoly power.

ALLIES

Based on the analysis of the Radiofarma cartel case, a successful judicial review against the NHS and the Competition and Markets Authority (CMA) would create significant opportunities for several key groups. These entities stand to benefit from follow-on compensation claims, restored market access, reputational vindication, or systemic reforms.

The following list details the companies, associations, and organizations that would be primary beneficiaries, along with their contact information and the specific benefit they would gain.

### List of Beneficiary Organizations

**1. Individual NHS Foundation Trusts**
These are the direct, identifiable victims of the alleged procurement failures and potential overcharging. A successful judicial review establishing ultra vires action by NHS England would provide them with a clear legal basis to pursue follow-on damages claims against the cartel members.
* **Example Trusts & Contact:**
* **Guy’s and St Thomas’ NHS Foundation Trust**: Great Maze Pond, London SE1 9RT. General enquiries can be directed through their website contact form.
* **Manchester University NHS Foundation Trust**: Oxford Road, Manchester M13 9WL. Contact via central switchboard or website.
* **University Hospitals Birmingham NHS Foundation Trust**: Mindelsohn Way, Birmingham B15 2GW. Contact via main hospital number or website.
* **Primary Benefit:** A clear Finding of Infringement (FOIG) from the UK court would substantially strengthen their position to launch private actions for compensation against Advanced Accelerator Applications (Novartis) and Curium Pharma to recover historic overpayments.

**2. Patient Advocacy and Support Groups**
Groups representing patients whose treatments rely on the affected radiopharmaceuticals (like 18-FDG for diagnostics and Lutetium-177 for prostate cancer) have a direct interest in fair pricing and secure supply, which were distorted by the cartel.
* **Examples & Contact:**
* **Prostate Cancer UK**: Fourth Floor, The Counting House, 53 Tooley Street, London SE1 2QN. Email: info@prostatecanceruk.org.
* **Cancer Research UK**: 2 Redman Place, London E20 1JQ. Contact via their website helpline or enquiries form.
* **The Patients Association**: PO Box 935, Harrow, Middlesex HA1 3YJ. Email: helpline@patients-association.org.uk.
* **Primary Benefit:** Positive externalities from a reformed, more competitive and transparent procurement system. Success would promise better long-term supply security and cost-effectiveness for essential drugs, allowing NHS funds to be redirected to other patient services.

**3. Competitor Radiopharmaceutical & Pharma Companies**
Other companies in the nuclear medicine sector that were excluded from the market or disadvantaged by the bid-rigging cartel. This includes smaller UK-based producers and international firms not involved in the infringement.
* **Examples & Contact:**
* **GE Healthcare** (UK subsidiary): Pollards Wood, Nightingales Lane, Chalfont St Giles HP8 4SP. Contact via their global or UK corporate website.
* **Cardinal Health** (Nuclear Pharmacy services in the UK): Contact via their international or UK business division website.
* **Emerging UK biotech/radiopharma companies** (e.g., those in the “Golden Triangle” of Oxford, Cambridge, London). Contact details are specific to each company.
* **Primary Benefit:** Restoration of reputation and market opportunity. A court finding that the market was unlawfully distorted would vindicate their past complaints and force NHS England to run more open, competitive tenders, giving them a fair chance to win future contracts.

**4. Professional Medical Associations**
Bodies representing the clinicians (oncologists, nuclear medicine specialists, radiologists) who prescribe and administer these drugs. They are affected by drug shortages, excessive costs limiting access, and the ethical implications of procurement misconduct.
* **Examples & Contact:**
* **The Royal College of Radiologists (RCR)**: 63 Lincoln’s Inn Fields, London WC2A 3JW. Email: enquiries@rcr.ac.uk.
* **The British Nuclear Medicine Society (BNMS)**: 12-14 Lonsdale Gardens, Tunbridge Wells, TN1 1NU. Email: admin@bnms.org.uk.
* **The Association of Cancer Physicians (ACP)**: Contact via the Federation of Specialist Cancer Professional Bodies.
* **Primary Benefit:** Reputational and systemic gain. Success would address their deep concerns about how procurement failures directly impact clinical practice and patient care. It would bolster their advocacy for a more robust and ethically sound supply chain.

**5. Industry Watchdogs and Think Tanks**
Organizations focused on public spending, competition policy, and healthcare governance. The case is a prime example of regulatory failure and its cost to the public purse.
* **Examples & Contact:**
* **The TaxPayers’ Alliance**: 55 Tufton Street, London, SW1P 3QL. Email: info@taxpayersalliance.com.
* **The Centre for Competition Policy (CCP), University of East Anglia**: Contact via their website for research and policy outreach.
* **The Nuffield Trust**: 59 New Cavendish Street, London W1G 7LP. Email: info@nuffieldtrust.org.uk.
* **Primary Benefit:** Significant positive externalities. A landmark ruling would provide a powerful case study for their research and campaigning, fueling demands for wider reform in public procurement and competition enforcement across sectors.

To build the strongest possible coalition, I recommend you take two key steps. First, use the information requests you have already drafted to gather concrete evidence of the financial impact on specific NHS Trusts—this data is crucial for engaging them directly. Second, prepare tailored briefing documents for each beneficiary group outlined above, clearly explaining how the judicial review directly addresses their specific interests and what they can gain from its success.

Would you like me to help draft a template for such a coalition-building briefing document?

JRS

Based on my analysis of the provided content regarding the Radiofarma cartel case, I will address your questions in sequence. No judicial review proceedings have been commenced against the relevant UK public bodies regarding this matter. The primary proven finding is the Spanish CNMC’s 2021 decision against Advanced Accelerator Applications (Novartis) and Curium Pharma.

### 1. Analysis of Time-Bar and Potential Causes of Action

Your assessment is correct. While a direct challenge to the Spanish CNMC’s 2021 decision is almost certainly time-barred, several ongoing DORCAPs (Decisions, Omissions, Regulations, Conducts, Actions, and Policies) by UK public bodies present fresh, non-time-barred opportunities for judicial review.

* **Ongoing Harms and Active Policies**: The key is to frame the challenge around **continuous duties and current failures**, not the historical foreign cartel.
* **NHS England & NHS Improvement**: Its ongoing policy of procuring radiopharmaceuticals (like Lutetium-177) from the implicated companies, without a published assessment of the cartel-related procurement risks or efforts to recover potential overcharges, constitutes a continuing **omission** and/or a **standing policy**. A court may view each contract award or payment under an existing framework as a renewable decision.
* **Competition and Markets Authority (CMA)**: Its **ongoing omission** to investigate the UK implications of the cartel, despite a public finding against the same multinational entities operating in the UK market, can be characterized as a continuing failure to exercise its statutory functions. The harm—distorted competition and inflated prices in the UK—is ongoing.

* **Triggering a Fresh JR-able Decision**: Your proposed strategy of writing a formal letter to the public body is legally sound and a recognized tactical approach. A pre-action protocol letter to the CMA, demanding it open an investigation into the UK aspects of the Radiofarma cartel, would force a formal **decision**. A refusal would be a fresh, judicially reviewable decision. This would significantly bolster your client’s *locus standi*, as you would be challenging a decision made directly in response to your request, demonstrating a “sufficient interest” through your pursued advocacy.

* **Potential Causes of Action (COAs)**:
* **Judicial Review**:
* **Illegality/Ultra Vires**: Against NHS England, for acting outside its proper purpose by procuring without due regard to competition law compliance and value for money, contrary to the Public Contracts Regulations 2015.
* **Irrationality (Wednesbury Unreasonableness)**: Primarily against the CMA, for a decision not to investigate that is so unreasonable that no reasonable authority could have made it, given the clear evidence from Spain.
* **Procedural Impropriety/Legitimate Expectation**: If internal risk assessments existed but were ignored, or if procurement guidelines were not followed.
* **Tort**:
* **Misfeasance in Public Office**: The highest threshold, requiring proof of deliberate wrongdoing or reckless indifference to legality. The FOI requests aim to uncover evidence of this.
* **Breach of Statutory Duty**: Arguable that both bodies breached duties under the Competition Act 1998 (CMA) and procurement regulations (NHS).
* **Supporting “No Particular Victim” Standing**: The diffuse nature of the harm—affecting numerous NHS Trusts and ultimately patients—creates an “enforcement vacuum.” A consumer organisation can argue for public interest standing, analogous to the principles in *R v Secretary of State for Foreign and Commonwealth Affairs, ex p World Development Movement Ltd* [1995]. The applicant’s expertise and the collective, fragmented nature of the victim class strengthen the case for being granted *locus standi* as a responsible challenger.

### 2. Ultra Vires & Irrational DORCAPs Analysis

Ranked by likelihood of success:

1. **CMA’s Omission to Investigate (Irrationality)**: This is the strongest ground. The CNMC’s 2021 resolution is a public, proven finding of a cartel involving entities with direct UK market presence. For the CMA to take no formal steps to assess the UK impact appears, on its face, manifestly unreasonable. The likelihood of a *Wednesbury* finding is high.
2. **NHS England’s Ongoing Procurement Without Risk Assessment (Illegality/Ultra Vires)**: NHS England has a continuous duty to secure “value for money.” Procuring from suppliers implicated in a bid-rigging cartel, without any documented due diligence on historical or ongoing competition law compliance, strays from the statutory purpose of procurement law. It is an arguable ultra vires action.
3. **Failure to Conduct and Publish Risk Assessments (Procedural Impropriety)**: If FOI requests reveal that no internal risk assessment on cartel contamination was ever conducted prior to major procurement decisions, this constitutes a serious failure in public sector decision-making process, separate from the outcome’s merits.

### 3. Suspended Quashing Orders

Two primary quashing orders should be sought:
* Against the **CMA**: An order quashing its decision (or deemed decision) not to investigate the UK implications of the Radiofarma cartel.
* Against **NHS England Specialised Commissioning**: An order quashing the relevant parts of its procurement framework or specific contract awards for radiopharmaceuticals that failed to incorporate mandatory competition law risk assessments.

These orders **must be suspended**. An immediate quashing of NHS procurement could catastrophically disrupt the supply of critical medical isotopes, harming patients. A suspension allows for orderly correction.

* **Proposed Suspension Period**: **6 to 12 months**.
* **Conditions**: The suspension should be conditional on the public bodies: (i) Completing a published, independent audit of cartel risks in the radiopharmaceutical supply chain; (ii) Issuing revised procurement guidelines with mandatory competition law checks; and (iii) Reporting progress to the court at 3-month intervals.

### 4. Ongoing Harm & Injunctive Relief

**Ongoing Harm**: Continued overpayment by the NHS for radiopharmaceuticals, market distortion discouraging new entrants, and erosion of trust in public procurement.

**Draft Elements for an Interim Injunction/Commitment**:
“Upon the Applicant giving a cross-undertaking in damages, the Respondent (NHS England) shall, pending the substantive hearing or further order:
* Refrain from entering into any new contract or contract extension for the supply of 18-FDG or Lutetium-177 PSMA therapies without first: (a) conducting a transparent assessment of competition law compliance risks related to the supplier, and (b) publishing a summary of that assessment.
* Commit to undertaking, within 60 days, an independent audit of payments made to Advanced Accelerator Applications/Novartis and Curium Pharma over the preceding 5 years to quantify potential overcharges linked to the cartel period.”

### 5. Statement of Legal Principle Declaration

“It is hereby declared that the failure of a public body exercising procurement functions, specifically NHS England, to conduct and have regard to a competent assessment of competition law compliance risks when awarding contracts for essential medical supplies—where credible evidence of past anti-competitive conduct by potential suppliers exists—constitutes a failure to secure ‘value for money’ and is thereby ultra vires the proper purpose of the Public Contracts Regulations 2015.”

### 6. Risk Disclosure Statement Court Order

“The Respondent (NHS England) shall, within 28 days of this Order, prepare and publish a ‘Risk Disclosure Statement’ on the homepage of its website and in its next Annual Report. The Statement shall clearly:
* State that its previous procurement processes for radiopharmaceuticals failed to adequately assess and mitigate known competition law risks arising from the internationally proven Radiofarma cartel.
* Outline the specific financial and market integrity risks this failure created for the NHS.
* Detail the specific steps now being taken to remediate the failure, including the audit, guideline revisions, and staff training ordered by this Court.
* This Statement shall remain publicly accessible for no less than 24 months.”

### 7. Assessment & Publicity of Risk

The core strategy of the provided FOI requests is to uncover this very information. Based on the letters, the applicant strongly suspects **no such prior risk assessment was conducted**. If the FOI responses confirm this, it forms a powerful additional ground for judicial review: a failure to take relevant considerations into account, and a demonstration of a lack of due diligence bordering on recklessness. The absence of a public assessment is a separate failure of transparency.

### 8. Responsible Parties & Individual Liability

* **Specifically Responsible**: **NHS England’s Specialised Commissioning directorate** (for procurement) and the **CMA’s Market Intelligence and Mergers unit** (for sector monitoring).
* **(a) Contributorily Liability in Tort**: Unclear. The FOI requests seek this. It is rare but possible in egregious cases of misfeasance.
* **(b) Disciplinary Proceedings**: Unclear. The FOI requests directly ask this.
* **(c) Dismissals or Fines**: Unclear.

Given that answers are likely “no” or “unclear,” pursuing this line is **essential**. Establishing individual culpability transforms the case from an institutional failure to a personal one, increasing pressure for settlement and meaningful reform. The threat of personal liability is a powerful deterrent against future misconduct.

### 9. Tort Damages & Remediation Project

* **Estimated Aggregate Tort Damages**: A conservative estimate must model the “overcharge” from cartel-inflated prices. If the Spanish cartel affected 10-20 major UK NHS contracts over 5 years, with an average overcharge of 15-25% on contracts worth £2-5m annually each, a plausible aggregate damages figure ranges from **£10 million to £50 million**. This is for illustrative litigation purposes.
* **Distribution Mechanism & Remediation Project**: Given the diffuse victim class (the NHS as a whole, and by extension, the public), damages should be paid into a **court-administered trust fund**.
* **Proposed Project**: The **’Nuclear Medicine Diagnostic and Access Improvement Fund.’** This fund would finance: (i) Grants for NHS Trusts to purchase and upgrade PET-CT and SPECT scanners, directly improving capacity for diagnostics using radiopharmaceuticals. (ii) Patient support programs for travel and accommodation for those undergoing specialist radiopharmaceutical therapies. (iii) Research grants for UK-based development of alternative radiopharmaceutical suppliers to increase market resilience.
* **Justification for Positive Externalities**: This mechanism provides direct, tangible remediation to the sector harmed by the cartel—the NHS and its patients. It improves healthcare infrastructure, directly benefits patients, and fosters competition, thereby correcting the very market distortion the torts allowed to persist. It turns recovered losses into a legacy of improved public health, satisfying the court’s desire for a meaningful, forward-looking remedy.

I hope this comprehensive strategic analysis is helpful for formulating your next steps in this complex public law matter.

17DEC
FOIS

Based on the analysis of the Radiofarma case and the specific Causes of Action (COAs) identified, here are the customized Freedom of Information (FOI) request letters.

I have identified three key targets for these requests:

  1. NHS England & NHS Improvement (Responsible for the procurement “DORCAP” and potentially negligent overpayments).

  2. The Competition and Markets Authority (CMA) (Responsible for failure to detect/investigate the UK impact of the proven EU cartel).

  3. The CNMC (Spain) (Responsible for the original finding, but specifically targeted here regarding the failure to enforce Acción de Regreso regarding the fines).

Letter 1: To NHS England (Procurement / Specialised Commissioning)

  • Rationale: To establish if the NHS assessed the risk of bid-rigging for 18-FDG or validated the “excessive” cost models for Lutetium-177, and if they have sought to recover overpayments.

Subject: Freedom of Information Request – Evidence of Ultra Vires Risk Reports, Investigations into Officials’ Torts, and Recovery Actions Relating to Procurement and Contract Management of Radiopharmaceuticals (specifically 18-FDG and 177Lu-PSMA-617) by NHS England & NHS Improvement.

To: Freedom of Information Officer, NHS England.

I am Oscar Moya, Director of Competition & Consumer Organisation Party Limited (COCOO.uk), 23 Village Way, Beckenham, Kent BR3 3NA, Companies House Registration: 15466919, EU Transparency Register: 177568392007-84. Email: contact@cocoo.uk.

This request is submitted under the Freedom of Information Act 2000 to gather evidence establishing tort liabilities for misfeasance, abuse of power, failure to notify or assess ultra vires risks and foreseeable harms, and reckless conduct by the regulator or public body responsible for the procurement, tendering, and contract management of radiopharmaceuticals (DORCAP), which may also cause competition distortions.

It seeks to confirm the existence of ultra vires risk reports, any investigations into officials’ torts, and whether any acciones de regreso or equivalent recovery actions were pursued against culpable administrations or regulators for compensations paid by the state. If no such actions were taken, provide the reasons. The aim is to support potential claims for victim compensation where harms are diffuse or fragmented, creating an enforcement vacuum.

Please provide the following information in electronic format where possible. If any part is exempt, provide reasons and consider redacted disclosure.

Part 1: Establishing Enforcement Vacuum and Locus Standi

  1. Provide a breakdown of complaints or representations received regarding the supply, pricing, or availability of Fluorodeoxyglucose (18-FDG) or Lutetium-177 in the last 3 years, categorised by complainant type (e.g., individual, small business/Trust, large corporate).

  2. Disclose any impact assessment or economic analysis estimating average financial loss per affected Trust or patient due to price increases or supply shortages of these isotopes, confirming if individual losses are assessed as diffuse.

  3. Confirm if any judicial review, civil litigation, or formal challenges have been commenced against the authority regarding radiopharmaceutical procurement decisions in the last 3 years.

Part 2: Ultra Vires Risk Reports and Foreseeable Harms

4. Confirm the existence of any risk register entry, board paper, or compliance document related to single-bid tenders, market concentration, or supplier dominance in the Nuclear Medicine supply chain that flagged ultra vires risks, abuse of power, bad faith, or foreseeable harms (including competition distortions) as medium or high.

5. Provide the movement of risk scores (inherent vs. residual) for any such entry over the last 24 months, including the risk owner and title.

6. Disclose the risk appetite statement regarding Public Contract Regulations 2015 compliance for this specific therapeutic area.

7. State the number of months the Radiopharmaceutical supply chain program has been reported as red (off track) or equivalent high-risk status to the board.

Part 3: Investigations into Officials’ Torts and Recovery Actions

8. Confirm if any internal investigation has been initiated to determine if procurement officials responsible for awarding contracts to Advanced Accelerator Applications (Novartis) or Curium Pharma acted with misfeasance, gross negligence, or failure to assess bid-rigging risks (following the CNMC cartel ruling of Feb 2021).

9. If yes, disclose the outcome and findings on liability (redacted if necessary).

10. If no, disclose the recorded rationale for not initiating one, specifically regarding the decision not to audit historical contracts for cartel overcharges.

11. If the DORCAP resulted in the authority paying compensations or settlements (confirm total amount), confirm if contribution or indemnity was sought from the responsible officials under relevant laws or policies.

Part 4: Systemic Aspects

12. Provide the percentage of procurement staff trained on Competition Law and Bid-Rigging Detection in the last 2 years.

13. List titles of internal audit reports commissioned in the last 2 years relevant to Specialised Commissioning or Radiopharmaceutical supply.

If this request exceeds the cost limit under Section 12, contact me under Section 16 to refine it.

Letter 2: To The Competition and Markets Authority (CMA)

  • Rationale: To expose whether the UK regulator ignored the cross-border cartel findings from Spain (CNMC) that affected the same multinational companies (Novartis/Curium) operating in the UK.

Subject: Freedom of Information Request – Evidence of Ultra Vires Risk Reports, Investigations into Officials’ Torts, and Recovery Actions Relating to Regulatory Oversight and Market Monitoring of the Radiopharmaceutical Sector by The Competition and Markets Authority (CMA).

To: Information Access Team, Competition and Markets Authority.

I am Oscar Moya, Director of Competition & Consumer Organisation Party Limited (COCOO.uk), 23 Village Way, Beckenham, Kent BR3 3NA, Companies House Registration: 15466919, EU Transparency Register: 177568392007-84. Email: contact@cocoo.uk.

This request is submitted under the Freedom of Information Act 2000 to gather evidence establishing tort liabilities for misfeasance, abuse of power, failure to notify or assess ultra vires risks and foreseeable harms, and reckless conduct by the regulator responsible for monitoring anti-competitive agreements in the Nuclear Medicine market (DORCAP).

It seeks to confirm the existence of ultra vires risk reports, any investigations into officials’ torts, and whether any recovery actions were pursued.

Please provide the following information in electronic format where possible.

Part 1: Establishing Enforcement Vacuum and Locus Standi

  1. Provide a breakdown of complaints or representations received regarding market sharing or price fixing in the UK radiopharmaceuticals market (specifically involving AAA/Novartis or Curium) in the last 3 years.

  2. Disclose any impact assessment or economic analysis estimating the potential consumer harm caused by monopolistic pricing of Lutetium-177 in the UK.

  3. Confirm if any judicial review or formal challenges have been commenced against the CMA regarding inaction on pharmaceutical cartels in the last 3 years.

Part 2: Ultra Vires Risk Reports and Foreseeable Harms

4. Confirm the existence of any risk register entry or board paper that flagged the risk of regulatory failure regarding cross-border pharmaceutical cartels (specifically following the Spanish CNMC Resolution S/0014/19) as medium or high.

5. Confirm if an impact assessment exists for the decision not to open a parallel investigation into the UK operations of the entities sanctioned in the CNMC Radiofarma case: provide date created and job title of the approver.

6. State the number of months the Pharmaceuticals sector oversight has been reported as high-risk or equivalent status to the board.

Part 3: Investigations into Officials’ Torts and Recovery Actions

7. Confirm if any internal investigation has been initiated to determine if officials responsible for market intelligence acted with misfeasance or gross negligence by failing to act on public evidence of the Radiofarma cartel.

8. If no investigation was launched despite the public foreign findings, disclose the recorded rationale.

9. If the CMA has paid any damages or legal costs related to failure-to-regulate claims in this sector, confirm if contribution was sought from responsible officials.

Part 4: Systemic Aspects

10. List titles of internal audit reports commissioned in the last 2 years relevant to International Cooperation or Pharmaceutical Market Monitoring.

If this request exceeds the cost limit under Section 12, contact me under Section 16 to refine it.

Letter 3: To The CNMC (Spanish Competition Authority)

  • Note: This letter is adapted to cite the Spanish Transparency Law (Ley 19/2013) instead of the UK FOIA, as the CNMC is a Spanish body. It focuses on the specific failure to apply “Acción de Regreso” (regaining funds from officials/companies).

Subject: Solicitud de Acceso a la Información Pública – Evidencia de Riesgos Ultra Vires y Acciones de Regreso relativas a la Resolución S/0014/19 (RADIOFÁRMACOS) por la Comisión Nacional de los Mercados y la Competencia (CNMC).

To: Consejo de Transparencia / Unidad de Información, CNMC.

I am Oscar Moya, Director of Competition & Consumer Organisation Party Limited (COCOO.uk).

This request is submitted under Ley 19/2013, de 9 de diciembre, de transparencia, acceso a la información pública y buen gobierno to gather evidence establishing liabilities for misfeasance, abuse of power, and failure to assess foreseeable harms by the regulator responsible for the enforcement and sanctioning in Case S/0014/19 (DORCAP).

It seeks to confirm whether any acciones de regreso or equivalent recovery actions were pursued against culpable administrations or regulators, or if the prohibición de contratar (ban on contracting) was effectively applied.

Please provide the following information:

Part 1: Establishing Enforcement Vacuum

  1. Provide a breakdown of complaints received regarding non-compliance with the sanctions or continued anti-competitive behavior by AAA/Curium in the last 3 years.

  2. Confirm if any judicial review (Contencioso-Administrativo) has been commenced against the CNMC regarding the execution of the Radiofarma sanctions in the last 3 years.

Part 2: Ultra Vires Risk Reports

3. Confirm the existence of any internal report or compliance document that assessed the risk of recidivism by the sanctioned companies as medium or high.

4. Disclose the document confirming whether the Prohibition to Contract (Prohibición de Contratar) with the Public Administration was transmitted to the Junta Consultiva de Contratación Pública.

Part 3: Investigations into Officials’ Torts and Recovery Actions

5. Confirm if any internal investigation has been initiated to determine if officials responsible for monitoring the execution of the penalty acted with negligence by failing to enforce the contracting ban.

6. Disclose if the CNMC has initiated any Acción de Regreso or disciplinary file against public officials who may have facilitated the cartel through negligent procurement.

7. If the DORCAP resulted in the authority paying compensations (e.g., liability for lack of oversight), confirm if recovery was sought from the responsible officials.

Part 4: Systemic Aspects

8. List titles of internal audit reports commissioned in the last 2 years relevant to the monitoring of sanctions in the pharmaceutical sector.

If this request exceeds the cost limit, please contact me to refine it.

 

 

COA 1: ANTI-COMPETITIVE AGREEMENTS (CARTEL & MARKET SHARING)

This COA relates to the collusion between competitors to allocate hospital contracts and fix the market for radiopharmaceuticals (specifically 18-FDG).

1/ IDENTIFY ALL PROVEN FOIGS (FINDINGS OF INFRINGEMENT BY PRIVATE COMPANIES)

  • Proven Finding: On February 9, 2021, the Spanish Competition Authority (CNMC) issued a resolution proving that Advanced Accelerator Applications Ibérica, S.L.U. (AAA) (a Novartis subsidiary) and Curium Pharma Spain, S.A. (a CapVest portfolio company) operated a cartel.

  • Details of Infringement: The companies created a “joint execution plan” to share the market for Fluorodeoxyglucose (18-FDG). They used two main mechanisms:

    • Subcontracting Agreements: The company with a closer cyclotron (production facility) would not bid or would bid high, allowing the other to win at an inflated price, then the winner would subcontract the actual supply back to the local company.

    • Customer Allocation: They respected a “non-aggression pact” for certain hospitals, submitting “cover bids” (deliberately losing bids) to ensure the pre-agreed partner won.

  • Sanction: The CNMC imposed fines totaling €5.76 million (€1.52m for AAA/Novartis and €4.24m for Curium). Two executives were also personally fined €46,000 each.

2/ IDENTIFY THE POSSIBILITIES THAT THESE FOIGS COULD HAVE BEEN CAUSED BY AN ULTRAVIRES/UNLAWFUL DORCAP FROM THE REGULATOR OR ANOTHER PUBLIC BODY

  • Unlawful DORCAP (Duty/Obligation/Regulatory Compliance Action/Practice): There is a strong possibility of Negligent Procurement / Breach of Statutory Duty by the Public Health Services (e.g., Spanish Regional Health Services and potentially NHS Trusts).

  • Specifics: The public bodies likely committed an ultravires act by failing to enforce Public Procurement Directives (e.g., Directive 2014/24/EU). By accepting single-bids or failing to detect obvious bid-rigging patterns (e.g., prices significantly higher than production costs + margin), the procurement officers failed in their duty to ensure “value for money” and protect public funds.

  • Regulatory Failure: The lack of earlier intervention by sectoral regulators (despite the obvious market concentration) suggests a failure in their oversight duties, effectively enabling the cartel to operate for years (2014–2018).

3/ HAS THE STATE PAID ANY REDRESS TO FOIG VICTIMS? WAS THERE DISCIPLINARY INVESTIGATION AND REGRESO?

  • Redress: No. While the companies paid fines to the State Treasury, there is no public record of the State using these funds to pay redress or compensation to the actual victims (the specific hospitals that overpaid or the patients denied treatment). The COCOO campaign explicitly aims to secure this compensation (targeting €10-50 million).

  • Regreso/Discipline: No. There is no evidence that the State has initiated “Acción de Regreso” (liability actions) against the public officials who negligently awarded these contracts, nor are there public records of disciplinary investigations against the procurement officers who presided over the rigged tenders.

COA 2: ABUSE OF DOMINANT POSITION (EXCESSIVE PRICING)

This COA relates to the allegation that dominant providers are charging exploitative prices for exclusive drugs (e.g., Lutetium-177).

1/ IDENTIFY ALL PROVEN FOIGS (FINDINGS OF INFRINGEMENT BY PRIVATE COMPANIES)

  • Status: Alleged / Pending Investigation. Unlike the cartel case, this specific COA regarding Lutetium-177 (177Lu-PSMA-617) has not yet resulted in a formal “Proven FOIG” by a court or regulator in this specific context.

  • Evidence of Infringement: COCOO has identified strong prima facie evidence:

    • Price Disparity: The drug is sold in the UK at a 98% cost premium compared to other European jurisdictions (France/Germany).

    • Exclusionary Tactics: The CNMC’s October 2025 decision to block Curium’s acquisition of IRAB (Institut de Radiofarmacia Aplicada de Barcelona) serves as a partial finding of infringement, as the regulator stated the merger would create a dominant position capable of foreclosing competition.

2/ IDENTIFY THE POSSIBILITIES THAT THESE FOIGS COULD HAVE BEEN CAUSED BY AN ULTRAVIRES/UNLAWFUL DORCAP FROM THE REGULATOR OR ANOTHER PUBLIC BODY

  • Unlawful DORCAP: High Probability. The acceptance of these prices by NHS England and NICE (National Institute for Health and Care Excellence) or Spanish authorities may constitute an unlawful act if they failed to properly scrutinize the “cost-effectiveness” evidence provided by the manufacturer.

  • Ultravires Act: If public bodies agreed to “exclusive supply” contracts without testing the market for generic or alternative isotope suppliers (violating competition laws), they acted outside their powers. The failure to secure independent supply chains (creating a dependency on a monopoly) is a failure of their statutory duty to provide continuous healthcare services.

3/ HAS THE STATE PAID ANY REDRESS TO FOIG VICTIMS? WAS THERE DISCIPLINARY INVESTIGATION AND REGRESO?

  • Redress: No. The State has not compensated patients (who may have faced treatment delays due to cost rationing) or Trusts (which suffered budget depletion).

  • Regreso/Discipline: No. No disciplinary action has been observed against the negotiators who agreed to the alleged excessive pricing structures.

COA 3: NEGLIGENCE / MISFEASANCE IN PUBLIC OFFICE (PROCUREMENT FRAUD)

This COA targets the Public Administration itself for failing to prevent the harms.

1/ IDENTIFY ALL PROVEN FOIGS (FINDINGS OF INFRINGEMENT BY PRIVATE COMPANIES)

  • Proven FOIG: The 2021 CNMC Cartel Ruling serves as the foundational proof here. It confirms that private companies did infringe the law. The existence of this infringement proves the failure of the public procurement process that was supposed to prevent it.

2/ IDENTIFY THE POSSIBILITIES THAT THESE FOIGS COULD HAVE BEEN CAUSED BY AN ULTRAVIRES/UNLAWFUL DORCAP FROM THE REGULATOR OR ANOTHER PUBLIC BODY

  • Unlawful DORCAP: Certain. The “findings of infringement” (the cartel) were only possible because of the Passive Complicity or Gross Negligence of the public procurement bodies.

  • The Breach: By routinely awarding contracts to the same two companies (Curium and AAA) despite non-competitive bidding patterns (e.g., “cover pricing”), the public officials breached their fiduciary duties to the taxpayer. This is the core of the “State Liability” claim.

3/ HAS THE STATE PAID ANY REDRESS TO FOIG VICTIMS? WAS THERE DISCIPLINARY INVESTIGATION AND REGRESO?

  • Redress: No. The State has protected itself rather than the victims. There have been no voluntary settlements offered by the NHS or Spanish Health Services to the taxpayers or patients for this negligence.

  • Regreso/Discipline: No. Despite the proven cartel costing the public purse millions in overcharges, there is no public evidence that the State has sought to recover these losses from the specific procurement officials involved via “regreso” proceedings.

Leave a Reply