Academic journal article Suffolk Transnational Law Review

Regulatory Metastasis: Altering the Regulatory and Payer Landscape to Change the Lives of Cancer Patients

Academic journal article Suffolk Transnational Law Review

Regulatory Metastasis: Altering the Regulatory and Payer Landscape to Change the Lives of Cancer Patients

Article excerpt


It's a perplexing circumstance: a cancer drug can receive a different approval decision in the United States and Belgium, despite a pharmaceutical company submitting the same clinical datasets to the United States Food & Drug Administration (FDA) and the European Medicines Agency (EMA). (1) Furthermore, cancer patients in the European Union living in different countries may not have access to the same cancer drugs, even if the drugs they seek are approved by the EMA. (2) The FDA and the EMA could not differ more in their approaches to approving oncology therapeutics and interacting with insurance bodies. (3) Despite the fact that European socialized healthcare systems are lauded for their seemingly patient-centric and access-friendly models; the reality could not be farther from the truth for those patients suffering due to cancer. (4) The EMA is a decentralized agency that adopts a "centralized procedure," attempting to harmonize the national healthcare agencies of twenty-eight Member States. (5) Combined with that, each Member State has a different process of regulating approved drugs in socialized insurance systems, resulting in patients in the European Union receiving different access to care for identical illnesses based on their locations. (6)

This Note explores the complex and exciting world of cancer care access: disparities between the United States and the European Union. (7) Part I begins by laying out the treatment paradigm for cancer and explains in chronological order how the treatment of cancer has advanced to its current stage. (8) Part II touches upon the history and mechanics of the FDA and the EMA, before explaining the structure of health insurance and reimbursement systems in the United States and European Union. (9) Part III lays out the differences in oncology drug approval timelines in the United States and Europe, as well as describes the current state of "politics in healthcare" and the effect it has on cancer patients. (10) Part IV delves into the problems with the European approach to healthcare and drug approvals, and why the model is not suited for cancer treatment in the modern era. (11) Finally, Part V concludes by juxtaposing the two agencies and making recommendations for reform in the EMA in order to increase access to oncology therapeutics throughout the European Union. (12)


A. Understanding Cancer

1. What is Cancer, and How Does it Present?

Cancer itself is not a single disease or condition, but is the name given to a collection of diseases that stem from the body reproducing malformed cells. (13) All cancers are characterized by cells dividing and replicating uncontrollably, thereby affecting the functionality of the body's complex and interdependent systems. (14) Cancer can occur anywhere in the human body, from the scalps of women to the breasts of men. (15) In a normal cell life cycle old cells die and new cells take their place; for patients suffering from cancer this process does not occur and doctors see old cells survive or multiply when they should die. (16) Clusters of these cancer cells are known as tumors. (17)

Tumors can be solid or liquid. (18) Solid tumors present as masses of benign or malignant tissue, usually obstructing key body cavities, or preventing normal organ function; liquid tumors present in the bloodstream, bone marrow, or other areas of the body where fluid readily flows and do not present as large masses of cells, but usually individual blood cells. (19) Both solid and liquid tumors can be either benign, meaning non-cancerous, or malignant, meaning cancerous. (20) Benign tumors, unless located in the brain, generally do not pose a risk to mortality as they do not spread to adjacent areas of the body, but conversely can grow to become large and still cause other health complications. (21) Malignant tumors, on the other hand, pose significant risks to a patient's mortality: they do not only spread uncontrollably, but pieces of them can break off from their primary location and travel around the body. …

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