17DEC PFIZER Y OTROS

20DEC

BA

Based on the review of the provided cocoo.uk context, the recent legal landscape surrounding Pfizer and other pharmaceutical companies (specifically the “17 companies” sanctioned in October 2025), and the uploaded legal files, here is the detailed professional report.

Executive Report: Judicial Review (JR) Opportunities – Pfizer & Others

Date: 20 December 2025

Context: Analysis of potential JR challenges arising from recent regulatory developments (e.g., Turkey antitrust fines, EU transparency rulings) and market conduct, assuming Spanish law aligns substantially with UK principles as instructed.

This report outlines three primary JR opportunities. Each includes a “Custom Balancing Act” weighing the Wider Public Interest (WPI) Goals and legal grounds against the procedural hurdles and Economic Efficiency (EE) defenses.

Opportunity 1: Challenge to Regulatory Inaction on Excessive Pricing (Article 102 TFEU)

Description:

A Judicial Review application against the National Competition Authority (e.g., CNMC in Spain or CMA in UK) for failing to investigate or sanction Pfizer and other dominant pharma entities for excessive pricing strategies, particularly referencing the patterns established in the UK Pfizer/Flynn case and recent cross-border findings.

Legal Basis:

  • Illegality / Failure to Act: The regulator has a mandatory duty to investigate credible allegations of abuse of dominance where WPIs are at stake “.

  • Material Considerations: Failure to take into account relevant factors (e.g., findings from other jurisdictions like the Turkey fines or UK CAT decisions) renders a decision/inaction unlawful “.

  • WPI Ground: Protection of Public Health and NHS Financial Stability (Quasi-markets) “.

Custom Balancing Act:

  • Arguments FOR (The WPI Case):

    • Regulatory Capture Risks: The regulator’s inaction may evidence “regulatory capture,” where the authority prioritizes industry stability or relationships over its duty to protect the public . You can argue the regulator is "captured" by the complexity of the pharma market and is deferring excessively to the companies .

    • Essential Elements Doctrine: Pricing of essential medicines touches upon “essential elements” of public policy (Health) which cannot be fully delegated to market forces or effectively ignored by the regulator “.

    • Precedent Alignment: Aligning with the Pfizer/Flynn principles (UK) strengthens the argument that the pricing models are legally “excessive” under Article 102 TFEU “.

    • Public Sector Equality Duty (PSED): High drug prices disproportionately impact vulnerable groups (elderly, disabled), engaging the PSED. The regulator must demonstrate “due regard” to eliminating this discrimination “.

  • Arguments AGAINST (The Defense/Risks):

    • Discretion & Expertise: Courts are often reluctant to interfere with a regulator’s “specialist knowledge” or resource allocation decisions (e.g., prioritizing other cases) “.

    • Economic Efficiency (EE) Defense: The regulator may argue that high prices are necessary to fund R&D (Dynamic Efficiency) and that intervention would chill innovation “.

    • Standard of Proof: Proving “excessive” pricing (the United Brands test) is notoriously difficult and fact-intensive.

  • Assessment:

    • Likelihood: Moderate to High if framed as a failure to investigate rather than a demand for a specific outcome. The “Duty of Candour” requires the regulator to disclose why they haven’t acted, which often reveals flawed reasoning “.

Opportunity 2: Transparency & Maladministration Challenge (Vaccine Procurement)

Description:

A JR targeting the Ministry of Health or European Commission (via national implementation) for “Maladministration” and lack of transparency in vaccine contracts (the “Pfizergate” text messages issue), specifically following the EU General Court’s annulment of the Commission’s refusal to provide access (May 2025).

Legal Basis:

  • Procedural Unfairness / Duty of Candour: Failure to disclose key decision-making communications breaches the duty of transparency and “due process” “.

  • Irrationality (Wednesbury): A decision to withhold information or procure without competitive tender (if applicable) may be deemed irrational if it ignores the WPI of democratic accountability “.

  • Legitimate Expectation (LE): The public has an LE that public procurement follows strict transparency rules to prevent corruption “.

Custom Balancing Act:

  • Arguments FOR (The WPI Case):

    • Democratic Accountability: Scrutiny of public expenditure is a fundamental WPI. The “essential elements” of the decision (spending billions) require high transparency “.

    • Human Rights (Article 10/11): Freedom of expression/information. Withholding these documents interferes with the public’s right to receive information “.

    • Precedent: The May 2025 EU ruling provides a strong “fact” that the refusal was unlawful. Ignorance of this ruling by national authorities would be an “error of law” “.

  • Arguments AGAINST (The Defense/Risks):

    • National Security/Public Order: The government may claim immunity or restricted disclosure grounds based on “security of supply” or commercial confidentiality “.

    • Time Limits: Challenges to the original contracts are time-barred (years ago). The challenge must be framed against a recent refusal to disclose or a new decision to renew contracts “.

    • Standing: Proving “sufficient interest” (standing) can be harder for general transparency claims unless brought by a specific pressure group (like Cocoo) with a track record “.

  • Assessment:

    • Likelihood: High for achieving disclosure (Interim Relief/Information Orders) “. Lower for overturning the contracts themselves due to “laches” (delay) and detrimental impact on third parties.

Opportunity 3: Challenge to “No-Poach” Agreements (Labor Market Cartel)

Description:

A JR or Competition Law complaint (leading to JR if rejected) regarding the “No-Poach” and wage-fixing agreements identified in the “17 companies” investigation (Turkey fines, October 2025). This targets the 17 identified drugmakers for distorting the labor market.

Legal Basis:

  • Competition Law Violation (Art 101 TFEU / UK Chapter I): “No-poach” agreements are increasingly viewed as “by object” restrictions of competition.

  • WPI Goal: Employment & Fair Wages: These agreements suppress wages and mobility, directly harming the WPI of “high level of employment” “.

Custom Balancing Act:

  • Arguments FOR (The WPI Case):

    • Labor Market Distortions: The conduct harms workers (a vulnerable class vs. corporate power). This aligns with WPI goals of social cohesion and employment protection “.

    • Cross-Border Effect: If proven in Turkey/US, it is highly probable the conduct exists in Spain/UK (global corporate policy). A refusal to investigate this “new evidence” would be irrational “.

    • Inequality: Such agreements exacerbate wealth inequality, violating the spirit of the Equality Act/PSED “.

  • Arguments AGAINST (The Defense/Risks):

    • Evidence Availability: The regulator may argue insufficient evidence exists locally.

    • Jurisdiction: The “No-Poach” theory is newer in some EU jurisdictions compared to the US; regulators might be cautious.

  • Assessment:

    • Likelihood: Moderate. A JR requiring the regulator to open an investigation is feasible if significant evidence (like the Turkey decision) is presented and the regulator ignores it.

Strategic Note: Spanish/UK Law Alignment

Under the instruction to assume Spanish law is substantially the same:

  • Grounds: The grounds of Illegality (Ilegalidad), Irrationality (Irracionalidad/Arbitrariedad), and Procedural Unfairness (Indefensión) are directly applicable “.

  • EU Dimensions: Both jurisdictions are bound (or influenced) by Article 102 TFEU and the duty to apply EU competition law effectively (Useful Effect Doctrine) “.

  • Remedies: You can seek Quashing Orders (Anulación) or Mandatory Orders (Mandato de hacer) to force an investigation “.

ALLIES

Based on the legal analysis of the Pfizer/Flynn Pharma Phenytoin Sodium case, the success of proposed judicial reviews (JR) against the Department of Health and Social Care (DHSC) for failing to pursue civil recovery would create significant opportunities for several organizations. These groups could benefit from a “follow-on” claim chance for compensation, gain positive externalities from the JR’s success, or have their reputation restored. Below is a list of such organizations with their official contact details.

Epilepsy Action
– **Address:** New Anstey House, Gate Way Drive, Yeadon, Leeds, LS19 7XY, United Kingdom[reference:0]
– **Email:** supportercare@epilepsy.org.uk (supporter care); health@epilepsy.org.uk (health enquiries)[reference:1]
– **Potential Benefit:** The proposed “NHS Epilepsy Care and Medication Access Innovation Fund” would directly benefit epilepsy patients. Success in the JR would likely lead to the creation of this court-supervised trust, advancing the charity’s mission.

British Generic Manufacturers Association (BGMA) trading as Medicines UK
– **Address:** 65 Gresham Street, London, EC2V 7NQ[reference:2]
– **Email:** info@medicinesuk.com; info@britishgenerics.co.uk[reference:3][reference:4]
– **Potential Benefit:** The JR aims to fund “UK-based generic manufacturing innovation to improve market resilience.” A successful outcome would strengthen the generic medicine sector, which was destabilized by the pricing abuse, directly benefiting the BGMA’s members.

Which? (Consumers’ Association)
– **Address:** 2 Marylebone Road, London, NW1 4DF[reference:5]
– **Email:** support@which.co.uk (member/customer service); recruitment@which.co.uk (general enquiries)[reference:6]
– **Potential Benefit:** A finding that the DHSC acted irrationally by not recovering public funds would validate consumer advocacy for fair pricing and stronger public accountability, enhancing Which?’s campaigning leverage.

Good Law Project
– **Address:** Good Law Project Ltd., 3 East Point, High Street, Seal, Sevenoaks, Kent, TN15 0EG[reference:7]
– **Email:** info@goodlawproject.org; press@goodlawproject.org (press enquiries)[reference:8]
– **Potential Benefit:** A successful JR would exemplify the type of public-interest litigation the organization pursues, bolstering its reputation and potentially providing a precedent for future cases against regulatory failures.

Public Law Project
– **Address:** The Design Works, 93-99 Goswell Road, London, EC1V 7EY[reference:9]
– **Email:** contact@publiclawproject.org.uk; enquiries@publiclawproject.org.uk[reference:10][reference:11]
– **Potential Benefit:** The JR would center on grounds of irrationality and illegality in public decision-making, aligning directly with the organization’s focus. A favorable judgment would affirm the importance of judicial review in holding public bodies accountable.

NHS Confederation
– **Address:** 2nd Floor, 18 Smith Square, London[reference:12]
– **Email:** governance@nhsconfed.org; enquiries@nhsconfed.org[reference:13][reference:14]
– **Potential Benefit:** The JR seeks to compel the recovery of NHS funds. Success would restore confidence in the system’s ability to protect its resources, positively impacting the reputation of the NHS Confederation as a representative body.

These organizations represent a cross-section of patients, consumers, the generic medicines industry, and public-interest law. A successful judicial review would provide them with tangible opportunities for follow-on claims, direct funding for their sectors, or significant reputational and strategic advantages in their advocacy work.

19DEC

Based on my analysis of the provided case materials, I will act as instructed and provide a strategic legal assessment. The core issue concerns the excessive pricing of Phenytoin Sodium by Pfizer and Flynn Pharma, the subsequent regulatory action by the Competition and Markets Authority (CMA), and the apparent failure by the Department of Health and Social Care (DHSC) to pursue full civil recovery for the NHS.

My analysis confirms that while the CMA’s infringement decision is finalized, significant, non-time-barred judicial review opportunities exist against other public bodies for their ongoing omissions and failures. These form the basis for the following advice.

### 1. Available Causes of Action and Standing

Judicial Review opportunities are not time-barred. The primary target is not the CMA’s 2024 decision, but the ongoing omission by the DHSC to initiate civil recovery proceedings. This is a continuing failure that refreshes daily.

* **Primary Cause of Action (Judicial Review):** The failure of the DHSC to make a decision on whether to pursue a “follow-on” damages claim against Pfizer/Flynn Pharma. This is challengeable on grounds of **irrationality** (*Wednesbury* unreasonableness) for failing to consider relevant factors (the unrecovered taxpayer loss) and/or **illegality** for acting ultra vires its fiduciary duty to safeguard public funds.
* **Supporting Tort Causes of Action:** While judicial review is the primary vehicle, the underlying conduct informs the grounds.
* **Misfeasance in Public Office:** If evidence surfaces that officials knowingly or recklessly disregarded their duty to recover public money.
* **Breach of Statutory Duty:** Arguable that the DHSC has a statutory duty under the National Health Service Act 2006 to use resources efficiently, which includes recovering losses from unlawful conduct.
* **Locus Standi for a “No Particular Victim” Applicant:** Your proposed applicant (representing the diffuse taxpayer interest) can establish standing. The harm—loss to the public purse—is real but diffuse across all taxpayers, creating a “**rational apathy**” scenario where no individual has a sufficient interest to sue. This is precisely the situation where the courts may grant standing to a responsible representative applicant to address an **”enforcement vacuum.”** The DHSC, as the primary victim, has “deep pockets” but has shown a failure to act, legitimizing a third-party challenge in the public interest. A pre-action letter forcing a decision would strengthen standing, as you would then be challenging a refusal you directly sought.

### 2. Ultra Vires & Irrational DORCAPs Analysis

Ranked by likelihood of successful challenge:

1. **DHSC’s Omission to Pursue Civil Recovery (Highest Likelihood):** This is a clear, ongoing policy of inaction. It is highly susceptible to a finding of irrationality. The DHSC has a known, quantifiable loss (the difference between the CMA fine and the total overspend). A decision not to recover these funds for the NHS, without a compelling public interest reason, is arguably so unreasonable that no reasonable authority would make it.
2. **MHRA’s Original Omission to Assess Economic Consequences (Medium Likelihood):** The 2012 decision to approve the “de-branding” of Epanutin without consulting the DHSC on the predictable pricing consequences. While the MHRA’s primary remit is safety, making a decision with foreseeable, catastrophic financial consequences for another public body without liaison could be seen as an irrational exercise of its discretion and a failure to cooperate inter-governmentally.
3. **CMA’s Historical Delay in Enforcement (Lower Likelihood):** The extreme delay between the 2012 conduct and the 2024 final decision is a past procedural failure. While it caused clear harm, challenging it now is less strategic as the substantive decision has been made. However, it remains relevant as evidence of systemic regulatory failure that contributed to the overall harm.

### 3. Recommended Suspended Quashing Orders

The most appropriate quashing order would target any formal or *de facto* DHSC policy not to seek civil recovery. We should seek an order quashing that “policy” or “decision.”

* **Argument for Suspension:** The order should be suspended for **3 months**. An immediate quashing would create administrative chaos, as the DHSC would have no lawful position. A suspension allows for an orderly, lawful decision-making process to be undertaken.
* **Condition:** The suspension should be conditional on the DHSC, within that 3-month period, undertaking a lawful, evidence-based decision-making process on whether to initiate civil proceedings, considering the full financial detriment to the NHS and its duty to the taxpayer.

### 4. Ongoing Harm & Injunctive Relief

* **Ongoing Harm:** The primary ongoing harm is the continuing depletion of NHS resources. Every day the unrecovered funds are not pursued, the public purse suffers a loss (through opportunity cost and the continued validation of the wrongdoers’ profit). There is also a continuing “deterrence vacuum,” signaling that the financial risk of such conduct is limited to a regulatory fine, not full restitution.
* **Draft Injunction Elements:** In any judicial review, we should seek a mandatory order requiring the DHSC to undertake the decision-making process on civil recovery within a court-defined timeframe. The application should state: “The Applicant seeks a mandatory order requiring the Respondent (DHSC) to conduct a formal, evidence-based assessment of the merits and public interest in pursuing a follow-on damages claim against Pfizer and Flynn Pharma for the unrecovered losses identified in the CMA’s infringement decision, and to reach a final decision thereon, within 90 days of this Court’s order.”

### 5. Statement of Legal Principle Declaration

“It is hereby declared that the Department of Health and Social Care, in exercising its functions under the National Health Service Act 2006 to manage NHS resources effectively, acts irrationally and in breach of its public law duties where it knowingly foregoes the pursuit of substantial civil recovery for losses caused to the NHS by unlawful conduct, in the absence of a compelling public interest justification for such omission.”

### 6. Risk Disclosure Statement Court Order

“The Court hereby orders the Department of Health and Social Care to publish, within 28 days of this order, a clear Risk Disclosure Statement on the homepage of its official website and in its next annual report. This statement must: (1) acknowledge the findings of this Court regarding its failure to assess civil recovery in the Phenytoin Sodium case; (2) explain the nature of the financial risk to the NHS budget created by such omissions; (3) outline the specific steps it is taking to implement the Court’s judgment and assess the recovery of funds; and (4) describe the systemic changes being implemented to prevent future occurrences of such enforcement failures.”

### 7. Assessment & Publicity of Risk

The FOI requests are designed to probe this exact point. Based on the strategy outlined, it is highly likely that **no integrated risk assessment** was conducted. The MHRA likely failed to assess the economic risk of de-branding. The DHSC likely failed to assess the litigation risk of not suing. The CMA may have assessed litigation risk for itself, but not the broader deterrence risk. The likely absence of these assessments is a powerful further ground for criticism, demonstrating a siloed and procedurally improper approach to a cross-departmental public harm.

### 8. Responsible Parties & Individual Liability

* **Primary Responsible Parties:** The DHSC’s Procurement and Commercial Directorate and the MHRA’s Licensing Division.
* **Individual Liability Status:** The FOI material suggests the answers to (a) contributorily liable, (b) disciplinary proceedings, and (c) dismissals/fines are almost certainly **”no.”** This is a critical failure. The absence of individual accountability perpetuates a culture of risk-free administrative failure. I strongly recommend pursuing this line in the FOI requests and, if confirmations of no action are received, highlighting this as an aggravating feature in judicial review proceedings, arguing for a mandatory order that the DHSC conduct such an internal accountability review.

### 9. Tort Damages & Remediation Project

* **Aggregate Damages Estimate:** The CMA fine was approximately £69 million. The annual cost to the NHS was estimated at £48-50 million over at least 4 years (2012-2016), suggesting a total overspend of **£192-200 million**. The unrecovered damages for a civil claim could therefore be reasonably estimated in the range of **£120-130 million** (total overspend minus fine).
* **Distribution Mechanism & Remediation Project:** Given the diffuse class of victims (taxpayers/patients), distributing damages directly is impossible. The solution is a **court-supervised therapeutic trust**.
* **Proposal:** The “NHS Epilepsy Care and Medication Access Innovation Fund.” Monies recovered would be placed in a trust.
* **Purpose:** To fund (a) advanced patient support programs for individuals with epilepsy and complex needs; (b) independent research into sustainable pricing models for essential generic medicines; and (c) grants for UK-based generic manufacturing innovation to improve market resilience.
* **Justification:** This creates direct positive externalities for the very sector harmed. It benefits epilepsy patients (the ultimate consumers of the drug), strengthens the generic medicine sector (which was destabilized by the abuse), and invests in systemic fixes to prevent future harm. It transforms punitive damages into proactive, public health-focused remediation, which a court would view favorably.

This strategic approach shifts the battle from the concluded competition case to the ongoing public law failure, creating a powerful, remedy-focused litigation that addresses the true systemic flaw.

15DEC

FOIS

Here are the three customised FOI requests tailored to the specific public bodies involved in the Pfizer/Flynn Pharma (Phenytoin Sodium) case.

These are designed to expose the “Enforcement Vacuum” (where the State failed to recover full damages) and “Regulatory Omission” (where the loophole was allowed).

1. Target: Department of Health & Social Care (DHSC)

Strategy: Probing the “Zombie Victim” angle. We need to know why the DHSC (or NHS) has not aggressively pursued a “Follow-On” civil claim to recover the full difference between the CMA fine (£69m) and the actual cost to the taxpayer (estimated £100m+). We are asking if they considered “Acción de Regreso” (recovery) against their own procurement officials for failing to stop this earlier.

To: Freedom of Information Team, Department of Health & Social Care

Subject: Re: Freedom of Information Request – Evidence of Ultra Vires Risk Reports & Recovery Actions regarding the Non-Pursuit of Full Civil Damages in the Phenytoin Sodium Case

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. It concerns the Department’s response to the excessive pricing of Phenytoin Sodium capsules by Pfizer and Flynn Pharma (2012–2016). Specifically, it investigates the Decision/Omission not to initiate (or the delay in initiating) a full “follow-on” civil claim for damages to recover the entirety of the overspend (beyond the CMA fine), and the lack of internal recovery actions against officials who oversaw the initial price hikes.

Please provide the following information:

Part 1: Establishing Enforcement Vacuum and Locus Standi

  • Confirm if the DHSC has conducted an internal financial analysis comparing the total cost impact of the Phenytoin Sodium price hikes (2012-2016) against the value of the fine imposed by the CMA (approx. £69m in the remitted decision).

  • Provide the date and title of any document where the Department assessed the economic feasibility of pursuing private litigation/damages against Pfizer/Flynn.

  • Confirm if the Department considers the Taxpayer fully compensated by the CMA fine alone. If not, confirm if the “unrecovered loss” is classified internally as a “diffuse harm” to the NHS budget.

Part 2: Ultra Vires Risk Reports and Foreseeable Harms

  • Confirm the existence of any risk register entry (2012–2013) that flagged the risk of “de-branding” loopholes (specifically regarding Epanutin/Phenytoin) as a high/red risk to the NHS budget.

  • Disclose the risk appetite statement regarding “Pharmaceutical Price Regulation Scheme (PPRS) loopholes” active during the period 2012–2016.

  • Did any internal legal advice (risk assessment) flag that failing to challenge the de-branding immediately might constitute an Ultra Vires omission or a breach of fiduciary duty to the Taxpayer?

Part 3: Investigations into Officials’ Torts and Recovery Actions

  • Confirm if any internal investigation was initiated to determine if DHSC/NHS procurement officials acted with gross negligence or recklessness by accepting the 2,600% price hike in 2012 without immediate legal challenge.

  • If the Department identifies a net financial loss (Total Overspend minus CMA Fine), has the Department sought “Acción de Regreso” (contribution/indemnity/surcharge) from any public officials or internal budget holders responsible for the delay in identifying this overcharge?

  • If no such investigation into official liability was conducted, disclose the recorded rationale for this omission.

Part 4: Systemic Aspects

  • Provide the percentage of procurement staff trained on “Competition Law Indicators” and “Abusive Pricing Recognition” in the last 2 years.

If this request exceeds the cost limit, contact me under Section 16.

2. Target: Competition and Markets Authority (CMA)

Strategy: Probing the “Too Soft Remedies” angle. We want to know if they assessed the risk that their fine was too low to act as a deterrent, and if they investigated their own staff for the extreme delay (2012 conduct $\to$ 2024 final decision), which effectively constitutes a denial of justice/remedy for the Taxpayer.

To: Freedom of Information Team, Competition and Markets Authority

Subject: Re: Freedom of Information Request – Evidence of Ultra Vires Risk Reports & Assessments of “Deterrence Insufficiency” in the Phenytoin Sodium Infringement Decision

I am Oscar Moya, Director of Competition & Consumer Organisation Party Limited (COCOO.uk), [Address/Details as above].

This request is submitted under the Freedom of Information Act 2000 regarding the CMA’s investigation into Pfizer/Flynn Pharma (Phenytoin Sodium). It seeks to establish whether the Authority assessed the risk that the fines imposed were insufficient to correct the market distortion, creating a need for third-party intervention.

Please provide the following information:

Part 1: Establishing Enforcement Vacuum and Locus Standi

  • Disclose any internal “Impact Assessment” or “Evaluation” that estimates the consumer/taxpayer detriment (in GBP) caused specifically by the delay in the final resolution of this case (from 2012 conduct to 2024 decision).

  • Provide the number of complaints received from patient advocacy groups or NHS bodies regarding the duration of this investigation.

Part 2: Ultra Vires Risk Reports and Foreseeable Harms

  • Confirm the existence of any Board Paper or Risk Register entry discussing the “Risk of Under-Deterrence” regarding the Phenytoin Sodium fines (i.e., the risk that the fine is merely seen as a “cost of doing business” by the infringer).

  • Disclose the movement of the “Litigation Risk” score for this specific case over the last 3 years.

  • Did the CMA perform a “Foreseeable Harm” assessment regarding the impact of this case’s timeline on the wider pharmaceutical generic market pricing strategies?

Part 3: Investigations into Officials’ Torts and Recovery Actions

  • Has the CMA conducted an internal review or investigation into its own case management to determine if administrative delays constituted misfeasance or a failure of statutory duty (Omission)?

  • If the lengthy legal process resulted in significant legal costs paid by the Taxpayer (CMA budget), confirm if any internal process was initiated to recover costs or sanction officials for procedural errors that led to the case being remitted by the CAT.

  • If no such review exists, disclose the rationale for not investigating the efficiency of this specific case handling.

Part 4: Systemic Aspects

  • List titles of internal audit reports commissioned in the last 2 years relevant to “Case Lifecycle Management” or “Enforcement Efficiency.”

If this request exceeds the cost limit, contact me under Section 16.

3. Target: Medicines and Healthcare products Regulatory Agency (MHRA)

Strategy: Probing the “Root Cause Omission”. The MHRA allowed the “de-branding” (switching from Epanutin to generic Phenytoin Sodium) which created the regulatory loophole for the price hike. We want to know if they risk-assessed this or if they are “Zombie Regulators” who ignored the economic consequences of their safety decisions.

To: Freedom of Information Team, MHRA

Subject: Re: Freedom of Information Request – Evidence of Ultra Vires Risk Reports regarding Marketing Authorisation Transfers (De-branding) of Phenytoin Sodium

I am Oscar Moya, Director of Competition & Consumer Organisation Party Limited (COCOO.uk), [Address/Details as above].

This request is submitted under the Freedom of Information Act 2000. It concerns the MHRA’s role in approving the transfer of Marketing Authorisations (MAs) for Epanutin/Phenytoin Sodium in 2012, which facilitated the removal of price controls (PPRS). This focuses on the Omission to assess the socio-economic risks of this regulatory approval.

Please provide the following information:

Part 1: Establishing Enforcement Vacuum and Locus Standi

  • Provide a breakdown of any representations made to the MHRA by the Department of Health (DHSC) regarding the pricing implications of de-branding branded medicines (specifically Phenytoin Sodium) between 2010 and 2013.

Part 2: Ultra Vires Risk Reports and Foreseeable Harms

  • Confirm the existence of any risk assessment or policy document from 2012 (or reviewed subsequently) that flagged the “Economic Impact on the NHS” as a relevant factor in granting Marketing Authorisation transfers.

  • If no such assessment exists, confirm if the MHRA holds a “Risk Appetite Statement” that explicitly excludes economic harm to the taxpayer from its regulatory considerations.

  • Disclose any internal reports discussing the “Ultra Vires Risk” of granting MAs that facilitate price gouging, even if the primary remit is safety.

Part 3: Investigations into Officials’ Torts and Recovery Actions

  • Confirm if any internal investigation was initiated to determine if MHRA officials acted with recklessness or lack of due diligence by approving the Pfizer/Flynn MA transfer without consulting pricing authorities.

  • Has the MHRA received any request for “contribution” or indemnity from the DHSC or CMA regarding the costs incurred due to this regulatory loophole?

  • If the MHRA considers it has no duty to prevent economic harm, please disclose the policy document stating this limitation of liability.

Part 4: Systemic Aspects

  • Provide the percentage of licensing staff trained on the inter-agency impact of MA transfers (e.g., impact on PPRS/VPAS schemes) in the last 2 years.

If this request exceeds the cost limit, contact me under Section 16.

As the Solicitor for COCOO (Competition & Consumer Organisation Party Limited), I have completed the due diligence on the Pfizer/Flynn Pharma (Phenytoin Sodium) case.

Below is the formal application of the “Lord Hope” Filters to this case, based on the current legal status as of December 2025 (referencing the CAT Judgment of Nov 2024 and Appeal Permission of March 2025).

EXECUTIVE SUMMARY: CASE STANDING ASSESSMENT

  • Case Name: Pfizer & Flynn Pharma v CMA (Phenytoin Sodium Excessive Pricing)

  • Primary Allegation: Excessive and unfair pricing (2,300%–2,600% hikes) of anti-epilepsy capsules, costing the NHS ~£48m/year extra.

  • Current Status: The Competition Appeal Tribunal (CAT) remade the decision in November 2024, imposing fines of £69m. Permission to appeal was granted in March 2025.

  • Filter Result: HIGH RISK OF REJECTION under the “Deep Pockets” rule, unless we pivot the claim to specific “Unclaimed Funds” or “Spanish/EU Cross-Border” angles where the primary victim (NHS/State) has failed to recoup civil damages.

DETAILED FILTER APPLICATION (The “Hope Test”)

I have applied your specific filters one by one to the facts of the Pfizer case.

1. The “Deep Pockets” Rule (Exclusionary Filter)

  • The Test: REJECT if the primary victim is a large corporation or well-funded Trade Association.

  • Fact Pattern: The direct victim of the excessive pricing was the National Health Service (NHS) and the Department of Health & Social Care (DHSC).

  • Analysis: The NHS is a state body with massive resources and a dedicated legal team (NHS Counter Fraud Authority / DHSC Legal). The DHSC has previously intervened in the CAT proceedings (e.g., arguing against interim relief for Flynn to protect patient funds). They have the financial incentive (£50m/year loss) and the legal standing to bring a “follow-on” damages claim.

  • VERDICT: FAIL (Primary Victim has Deep Pockets).

    • Solicitor’s Note: To pass this filter, we must argue that the NHS is politically conflicted or has failed to sue for civil damages (the “Acción de Regreso” angle), leaving the Taxpayer uncompensated despite the regulatory fine.

2. The “Contractual Dispute” Rule

  • The Test: REJECT if the issue is a commercial contract dispute between private entities (B2B).

  • Fact Pattern: The dispute originated from Pfizer transferring Marketing Authorisations to Flynn to “de-brand” the drug and bypass the Pharmaceutical Price Regulation Scheme (PPRS).

  • Analysis: While it involves contracts, the core finding by the CAT (Nov 2024) is a breach of Competition Law (Abuse of Dominance), not contract law. It is a tort against the market, not a breach of contract.

  • VERDICT: PASS. This is a regulatory/public law breach, not a private contractual dispute.

3. The “Specific Interest” Rule

  • The Test: REJECT if there is a clearly identifiable victim group currently suing (e.g., active Class Action).

  • Fact Pattern:

    • NHS: Likely has a standing claim or settlement discussions.

    • Generic Manufacturers: Teva and others might have claims for exclusion, but they are private entities.

    • Patients: Unlike US cases, UK patients rarely pay the full cost, making a consumer class action difficult unless we focus on private patients or lost access to care.

  • VERDICT: BORDERLINE. If the NHS is actively suing for damages, we are blocked. If they are not, we have an opening to represent the “Taxpayer Interest” (asserting the State is negligent in recovering funds).

4. The “Rational Apathy” Rule (Inclusionary Filter)

  • The Test: KEEP if harm per person is small (<£1,000) but aggregate is massive.

  • Fact Pattern:

    • Per Taxpayer: The cost is pennies (spread across 60m people). No individual taxpayer will sue Pfizer for a 50p loss.

    • Aggregate: £48m–£50m per year.

  • VERDICT: PASS. This fits the classic Lord Hope definition of diffuse harm where no individual has standing, provided we successfully argue the NHS (the intermediate victim) is a “Zombie Regulator” failing to recover this money for the public pot.

5. The “Rule of Law” / “Enforcement Vacuum” Rule

  • The Test: KEEP if there is a pure Ultra Vires omission or “Enforcement Vacuum”.

  • Fact Pattern: The CMA did act (fines of £84m $\rightarrow$ £70m $\rightarrow$ £69m). The CAT did uphold the infringement in Nov 2024.

  • Analysis: There is no regulatory vacuum regarding the fine. The State has punished the conduct.

  • VERDICT: FAIL (on the surface).

    • Strategic Pivot: The vacuum exists only if the Civil Compensation (Damages) has not been collected. Fines go to the Treasury’s consolidated fund; they do not necessarily compensate the specific NHS budget or the Spanish Health Service.

    • COCOO Angle: We must use Filter #6 (Unclaimed Compensations). If the State has not initiated the “Acción de Regreso” (recovery action) against the agents who allowed this, or if the NHS fails to claim civil damages, that is the vacuum.

STRATEGIC RECOMMENDATION FOR COCOO

Based on the filters, a direct claim for “Excessive Pricing” duplicates the CMA/NHS work and will likely be struck out for lack of standing. We must pivot to the following specific claims:

Target 1: The “Zombie Victim” (Filter #6 – Acción de Regreso)

  • Argument: The CMA fined Pfizer £69m, but the actual overcharge was over £100m+ over 4 years.

  • Investigation: Search specifically: Has the DHSC/NHS filed a civil claim to recover the difference between the fine and the actual loss?

  • COCOO Locus: If they haven’t, COCOO claims standing on behalf of the Taxpayer to force the State to recover these funds (or sue the State for Omission/State Aid by allowing Pfizer to keep the illicit profits).

Target 2: The “Spanish Connection” (Cross-Border)

  • Argument: Your internal files indicate an investigation into Spain. The UK CMA has done the work; has the CNMC (Spain) or the Spanish Health Ministry acted?

  • COCOO Locus: If the Spanish regulator is “Zombie” (inactive) despite the UK precedent, COCOO represents the EU/Spanish Patient & Taxpayer to demand an investigation based on the UK evidence (“Evidencia Grok”).

Target 3: “Too Soft Remedies” (Filter #4)

  • Argument: The £69m fine is arguably “cost of doing business” compared to the profits made.

  • COCOO Locus: Judicial Review of the CMA/CAT decision for insufficient deterrence, arguing the fine calculation (based on “reasonable rate of return”) was flawed and harms the Wider Public Interest (WPI).

Next Step: I will need to verify if the NHS has settled privately with Pfizer. If they have, our “Taxpayer” claim is weak. If they have not, we proceed with Target 1.

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