A pharmacovigilance system for treatment access and medical donation programs: The Max Foundation experience.

BACKGROUND: Cancer is a major burden of disease in low- and middle-income countries (LMICs) yet financial barriers limit access to life-saving oncology drugs. Medical donation and other drug access programs can help improve patient access to essential medicines, such as quality assured oncology drugs in LMICs. However, there are no published examples of the conduct of pharmacovigilance with donated medical products intended for use in LMICs where pharmacovigilance is weak. We describe a partnership between a pharmaceutical company and a non-governmental organization as a case example that addresses the challenges in performing pharmacovigilance with donated medicines in LMICs. The Max Foundation's direct to patient model is designed to improve global access to quality assured oncology drugs through access programs such as the Glivec® (generic name: imatinib) International Patient Assistance Program (GIPAP). RESULTS: Between 2013 and 2016, in the course of managing the GIPAP program, The Max Foundation was made aware of 13,039 instances of adverse events (AEs). These AEs were reported to The Max Foundation by physicians, patients, and caregivers. The Max Foundation reported these AEs to Novartis through the AE reporting tool within its Patient Assistance Tracking System (PATS). Physicians were the reporters for 58% of the AEs while the remainder of the AEs were reported directly by patients or caregivers. The overall rate of reported AEs remained relatively steady for the years 2013 through 2016 at 92, 95, 86, and 97 AEs reported per 1000 persons who received Glivec® per year, respectively. The vast majority of adverse events (85%) were reported from countries where The Max Foundation has a MaxStation, i.e., where The Max Foundation staff interact directly with physicians and patients at clinics or over the phone. AE reporting rates were consistently higher in all years studied from countries where The Max Foundation has a MaxStation. While India accounted for the largest number of reported adverse events in 2016 (1990), Bolivia had the highest rate of reported adverse events at 484 AEs per 1000 patients. CONCLUSIONS: International patient assistance programs that provide access to medicines can have an important role in assisting pharmaceutical companies in fulfilling their pharmacovigilance obligations. Adverse event information collected through PATS can potentially contribute to the overall body of knowledge on the safety of medicinal products.

[The Glivec® case: the first example of a global debate on the drug patent system]. / El caso Glivec®: primer ejemplo de debate global en torno al sistema de patentes de medicamentos.

OBJECTIVE: To describe the sequence of events involving the Glivec® case in India and to analyze the opinions generated in distinct settings. METHOD: We performed a systematic search for articles concerning the imatinib (Glivec®) patent in India. We selected those sources that described the events, decisions of the authorities involved, and press and scientific opinions. Dates and arguments presented by the involved parties were clearly identified. RESULTS: Of 886 documents initially obtained, we selected 40 documents published between 2003 and 2013. Most of them were press news and commentaries. The process lasted 7 years, starting in 2006 when the Indian Patent Office rejected the patent application filed by Novartis. It ended in 2013 when the Indian Supreme Court upheld this decision. It was argued that the Indian Patent Law would facilitate access to medicines in the Third World and the final decision has received support by the general population. Although the court's final decision has been supported by several institutions, an objective analysis should also take into account the arguments of the pharmaceutical companies and other entities. CONCLUSION: The Glivec® case gave rise to an intense debate on the appropriateness of international standards on patents, their applicability and how they should be adopted in each country. This case, as well as other cases, should serve to stimulate reflection on the international patent system and to achieve scenarios in which the health of the poorest populations is protected but also balanced against intellectual property protection and innovation.