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  • Ladies and gentlemen

  • let me extend my warm greetings to you from the

  • Geneva headquarters of the World Health Organization.

  • You are commemorating the 100th antiretroviral drug

  • granted tentative approval by the FDA.

  • This is an achievement welcomed by WHO on many

  • levels.

  • The HIV/AIDS epidemic changed international

  • thinking about diseases and the need for care in

  • significant ways.

  • It brought unprecedented attention to the issue of

  • fair access to medicines.

  • When effective antiretroviral treatments

  • became available, an ability to pay became

  • equivalent to an ability to survive for many

  • millions of patients.

  • The work done by the FDA, in support of the

  • President's Emergency Program for AIDS Relief,

  • promotes the expedited approval of generic

  • products that meet the high standards of the FDA.

  • The benefits of this work are extended through

  • collaboration with the WHO prequalification of

  • medicines program.

  • This program gives quality medical products a

  • seal of approval that guides purchasing

  • decisions, whether by national governments, aid

  • programs, or UN agencies.

  • Established in 2001, the WHO program pioneered

  • work on the assessment and pre-qualification of the

  • first generic antiretroviral medicines

  • and the first triple fixed-dose combination

  • product for HIV/AIDS.

  • At the time, this was a breakthrough in regulatory

  • thinking.

  • The program also established a framework

  • for working with regulatory authorities and

  • assisting industry in ways that ultimately benefit

  • patients.

  • The authorization procedures followed by FDA

  • operate as an incentive for generic manufacturers

  • to enter the market for antiretroviral medicines.

  • Purchase by USAID adds an economic incentive.

  • Competition among generic manufacturers brings

  • prices down.

  • By special arrangement, products approved by the

  • FDA are added by the Program to its list of

  • pre-qualified medicinal products.

  • In the case of therapies for HIV/AIDS, what this

  • means is first-rate medicines, from multiple

  • manufacturers, at lower prices, in a process that

  • is efficient, inclusive, and widely accessible.

  • Everyone benefits, but most especially people in

  • need of these life-prolonging medicines.

  • This work further shows that public health can

  • indeed achieve greater efficiency without

  • sacrificing quality.

  • Improving access to good quality medicinal products

  • is a core objective of public health efforts, and

  • one with a direct and measurable impact on

  • health.

  • I am sure that many millions of people in the

  • developing world are equally grateful to the

  • FDA for its work in this area.

  • Thank you and congratulations.

Ladies and gentlemen

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マーガレット・チャン事務局長:PEPFARの下で100番目のHIV/AIDS治療薬の購入を承認 (Dr Margaret Chan Director-General: 100th HIV/AIDS Drug Authorized for Purchase Under PEPFAR)

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    杏 に公開 2021 年 01 月 14 日
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