Market and patient access to new oncology products in Europe: a current, multidisciplinary perspective

Abstract

To air challenging issues related to patient and market access to new anticancer agents, the Biotherapy Development Association--an international group focused on developing targeted cancer therapies using biological agents--convened a meeting on 29 November 2007 in Brussels, Belgium. The meeting provided a forum for representatives of pharmaceutical companies and academia to interact with European regulatory and postregulatory agencies. The goal was to increase all parties' understanding of their counterparts' roles in the development, licensure, and appraisal of new agents for cancer treatment, events guided by an understanding that cancer patients should have rapid and equitable access to life-prolonging treatments. Among the outcomes of the meeting were a greater understanding of the barriers facing drug developers in an evolving postregulatory world, clarity about what regulatory and postregulatory bodies expect to see in dossiers of new anticancer agents as they contemplate licensure and reimbursement, and several sets of recommendations to optimize patients' access to innovative, safe, effective, and fairly priced cancer treatments.

Evolution of costs of cancer drugs in a Portuguese hospital

“…Oncology has registered important progress in available treatments, especially cancer drugs, resulting in a significant improvement in healthcare in recent years, both in terms of overall survival and quality of care [20][21][22][23][24] . In Europe, between 1998 and 2007, there was an important increase in direct costs related to cancer drugs [4,16,25] .…”

Lietuvos sveikatos politikos retų ligų srityje kryptys: dabartinė teisinė padėtis ir problemos

“…2008, 9(3): 219. jančio dokumento tekste (o visi jie yra ir Lietuvos teisinės sistemos dalis) nėra detalesnių nuostatų, nurodančių gyvybės apsaugos pradžios ir pabaigos momentą. Nors juose skelbiama, kad ,,Kiekvienas turi teisę į gyvybę" (Visuotinės žmogaus teisių deklaracijos 34 3 str. ), ,,Kiekvieno teisę į gyvybę gina įstatymas" (Tarptautinio pilietinių ir politinių teisių pakto 35 6 str.…”

“…Žmogaus gyvybės apsaugos prenatalinėje fazėje problema Lietuvoje yra dviprasmiška. Iki šiol nėra nacionalinių teisės aktų, apibrėžiančių žmogaus gyvybės iki gimimo statusą, nors keleto projektų, kuriais iš esmės siūloma pakeisti šiuo 34 Visuotinė žmogaus teisių deklaracija. …”

Optimizing investigator-led oncology research in Europe

“…15 For too long now, there has been a lack of pre-clinical and molecular studies for cancer drugs, leading to high failure rates 15 and resulting in a near unchanged number of new drugs coming onto the market in the past 30 years. 16 Mechanistic studies, known as 'personalized' medicine, are attractive to industry if there is a link between a 'marker' and a 'targeted' drug, for example, as shown by the antibody treatment for breast cancer with Herceptin® (Genentech). In the absence of such markers, research and post-marketing investigations of drugs in specific patient subgroups or for orphan diseases will be left to independent researchers.…”