Our Life Sciences Legal Forum offers quarterly sessions focusing on hot topics within the life sciences sector. In our recent webinar, we explored the complexities of borderline products, focusing on categories that often raise challenging questions. This blog series delves into these issues, with a particular emphasis on medicinal devices and MedTech, medicines and ATMPs, food supplements, consumer products, and advertising. You can read the first instalment here.
Understanding Borderline Products
Borderline products are those that may fall into more than one product category. Determining their classification requires careful consideration of factors such as intended purpose, mode of action, and product claims. Understanding these nuances is crucial for regulatory compliance and cost-effective product development.
Focus on Medicinal Products
In this second instalment, we focus on medicinal products and their borderlines with other product types. Current areas of focus include:
- Combination Drug-Device Products: These include implanted products for delivering contraceptive medicines or immunosuppressant antibody products with automatic injecting devices.
- Companion Diagnostics (CDx): Diagnostic products used to determine patient suitability for a medicinal product, such as trastuzumab for HER2+ breast cancer.
- Advanced Therapy Medicinal Products (ATMPs): Complex cell and gene therapies, like “CASGEVY”, which uses CRISPR technology to treat transfusion-dependent beta-thalassemia or sickle cell anaemia.
Medicines Regulations
To fall within medicines regulations, a product must be a "substance or combination of substances" with a medical purpose, either through its presentation or function. As discussed in our first blog, a medical device also has a medical purpose but acts through physical or mechanical means rather than "pharmacological, immunological, or metabolic means." While this borderline is usually clear, some product types are difficult to classify.
Case Study: FEMANNOSE
The medicines/medical device borderline was analysed in a recent EU case involving “FEMANNOSE”, marketed as a medical device for preventing and treating urinary tract infections. The main constituent, D-mannose, binds to bacteria, preventing them from adhering to the bladder wall. The European Court of Justice ruled that the product worked through a pharmacological action and should be considered a medicinal product.
Classification Challenges
Device-type products incorporating a medicine or used to administer it could fall into either category. Classification depends on the primary intended function and method of action. For example, a non-refillable, single-use device for injecting a therapeutic antibody is considered a medicinal product, while a heparin-coated catheter would fall under medical devices legislation.
Companion Diagnostics
Devices used alongside medicinal products, such as CDx, must be assessed as medical devices with specific additional requirements. Under updated EU regulations, CDx assessment includes obtaining a scientific opinion from the European Medicines Agency in addition to the usual medical device pathway.
Tissue and Cell-Based Products
Tissue and cell-based products can be difficult to classify, potentially falling under medicinal products, transplants, transfusions, devices, or other categories. ATMPs include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. Distinguishing ATMPs involves analysing the extent to which cells or tissues are "engineered" or used differently from their original function.
Regulatory Authorities
For tissue and cell-based therapies, different regulatory authorities may need to be involved in addition to the medicines regulator, the MHRA. In the UK, the Human Fertilisation and Embryology Authority (HFEA) oversees work involving gametes or embryos, while the Human Tissue Authority (HTA) handles other tissues and cells. Collaboration between regulators is essential for assessing cutting-edge products appropriately.
In the third instalment of this series, we will turn to food supplements and other consumer products, with a particular focus on advertising regulations.
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