Pharmaceutical Challenges of Article 31bis Sample Clauses

Pharmaceutical Challenges of Article 31bis. Article 31bis and its accompanying Annex function well with regards to chemical-based formulations, but it is not apparent that their development has taken into account novel developing therapeutics, including biologics, cell- based therapies, and gene-based therapies. Furthermore, the framework was developed well before the advent of any personalized medicine treatments, and, as a result, does not factor in how access to these types of therapeutics could be managed under the framework. Chemical-based formulations and pharmaceutical products are, relatively speaking, simple. They often consist of a single active ingredient that is formulated in a tablet, capsule, or liquid, combined with various other inert components and fillers that are required for various reasons including stability, delivery, and administration purposes.122 The active ingredients and 117. Xxxxxxxx, supra note 108, at 258. 118. R.C. Bird, Developing nations and the compulsory license: maximizing access to essential medicines while minimizing investment side effects, 37 J. LAW. MED. ETHICS 209 (2009); Xxxxxxxx, supra note 108. 119. Promoting Access, supra note 99; Bird, supra note 118; Xxxxxxxx, supra note 108. 120. Bird, supra note 118. 121. Bird, supra note 118; Xxxxxxxx, supra note 108. 122. See Glossary of Terms, U.S. FOOD AND DRUG ADMIN., (Nov. 14, 2017) xxxxx://xxx.xxx.xxx/drugs/drug-approvals-and-databases/drugsfda-glossary-terms#X. XXXXXXX 2.3 AT 1030AM .DOCX (DO NOT DELETE) 2/3/21 10:59 AM 24 Gonzaga Journal of International Law Vol. 24: 1 formulations are, therefore, identical from pill to pill or capsule to capsule. Examples of chemical-based formulations are acetaminophen (Tylenol®; used in the treatment of pain and fever), statins (e.g., Lipitor®; used in the treatment of high blood cholesterol), and antibiotics (used in the treatment of bacterial infections).123 In contrast, biologics, which are produced from biological sources and that include products like vaccines, blood components, cell-based therapies, antibody-based therapies, and gene-based therapies, are mixtures of various components that are far more complex than a simple chemical formulation.124 Examples of biologics are adalimumab (Humira®; antibody-based treatment for rheumatoid arthritis),125 CAR T-cell therapies (like Yescarta® and Kymriah™; chimeric antigen receptor T cells, isolated from a patient, reprogrammed, and readministered to the patient; used in the treatment of various types of cancer),126 and vo...
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