Unregulated ATMPs in the EU: A Threat to Patient Safety

Unregulated ATMPs are being marketed in the EU, posing serious health risks. Authorities urge patients to verify treatments and seek only approved therapies.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have raised concerns about the increasing availability of unregulated advanced therapy medicinal products (ATMPs) in the European Union (EU). These therapies, which use cells, genes, or tissues to treat medical conditions, have the potential to revolutionize medicine. However, when not properly regulated, they can pose serious risks to patient health and safety.

Why Regulation Matters

ATMPs approved by the EMA or national regulatory bodies undergo thorough evaluation to confirm their safety, efficacy, and quality. This ensures that patients receive treatments that have been rigorously tested. Unfortunately, some companies and clinics are bypassing these requirements and offering unregulated ATMPs directly to patients, often without sufficient scientific evidence to support their claims.

One of the most concerning examples is unregulated dendritic cell therapy, a type of immunotherapy used in cancer treatment. While properly approved versions of this treatment show promise, unauthorized versions lack necessary regulatory oversight, increasing the risk of harmful side effects, poor manufacturing quality, and financial exploitation of vulnerable patients.

Risks of Unregulated ATMPs

Patients should be cautious of unregulated ATMPs, as they can:

• Cause unexpected and severe side effects due to insufficient testing
• Suffer from poor quality control, leading to contamination or inconsistencies
• Be marketed with misleading or exaggerated claims
• Result in significant financial and emotional distress due to ineffective treatment

Ensuring Safe Access to ATMPs

Legal ATMPs in the EU must fall into one of the following categories:

• Authorized through the EMA’s central approval process
• Provided within an approved clinical trial
• Given special exemption by a national authority for hospital use under strict conditions

If a provider cannot confirm that an ATMP meets one of these criteria, patients should be wary. Unregulated treatments often lack transparency and accountability, putting patient safety at risk. Suspicious cases should be reported to national authorities to prevent harm to others.

How to Protect Yourself

To ensure safe treatment, patients should:

• Consult with trusted medical professionals before considering any ATMP
• Check with the EMA or national regulatory authorities to confirm approval status
• Be cautious of treatments advertised aggressively online or through social media
• Seek a second opinion before proceeding with any therapy

Authorities across the EU are actively working to stop the illegal distribution of unregulated ATMPs and, in some cases, pursuing legal action against those responsible.

At ATMP Sweden, we are committed to ensuring that ATMPs are developed and provided under strict regulatory guidelines, allowing patients to benefit from innovative therapies without unnecessary risks. By fostering collaboration between national and international stakeholders, Sweden aims to be at the forefront of ATMP advancements while prioritizing patient safety.

Consult relevant authorities for guidance on approved ATMP treatments.

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