WHO Drug Information Vol. 24, No. 4, 2010

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WHO Drug Information Vol. 24, No. 4, 2010Recent Publications,Information and EventsUS Government to sharepatents with MedicinesPatent PoolUnited States of America — A PresidentialPolicy Directive on Global Developmenthas been signed that focuses onsustainable development outcomes andplaces a premium on broad-basedeconomic growth, democratic governance,game-changing innovations, andsustainable systems for meeting basichuman needs. The new Policy aims toleverage innovation to solve long-standingdevelopment challenges, encouragenew models for innovation and to increasedeveloping country utilization ofscience and technology.The initial contribution by the NationalInstitutes of Health (NIH) and co-patentowner, the University of Illinois at Chicago,takes an important step towardmaking affordable and appropriate HIVmedicines available to patients aroundthe world. It builds on the President’sprevious commitment to support humanitarianlicensing policies to ensure thatmedications developed with US taxpayerdollars are available off-patent in developingcountries. The patents have previouslybeen licensed for the HIV drugdarunavir. The license to the MedicinesPatent Pool stipulates that the technologywill be available for the benefit of all lowandmiddle-income countries, as definedby the World Bank, and is royalty-free.The Medicines Patent Pool is supportedby UNITAID, an innovative global healthfinancing mechanism that was cofoundedby Brazil, Chile, France, Norwayand the United Kingdom at the UnitedNations General Assembly in 2006. It is avoluntary mechanism through whichpharmaceutical patent holders canchoose to license their patents tothe Pool.Reference: Fact Sheet, 30 September 2010at http://www.WhiteHouse.govClinical trials and globalmedicines developmentEuropean Union — In September 2010,The European Medicines Agency (EMA)held an international workshop with abroad cross section of stakeholders fromaround the world to discuss a way forwardfor a global framework of clinicaltrials that has at its heart the protection ofthe rights, safety and wellbeing of patientsparticipating in clinical trials anywherein the world.The workshop was part of the consultationprocess on the Agency’s ‘ReflectionPaper on Ethical and Good ClinicalPractice (GCP) Aspects of Clinical Trialsof Medicinal Products for Human UseConducted in Third Countries and submittedin Marketing Authorization Applicationsto the EMA’.Some 170 participants from 50 countriesprovided feedback on the ReflectionPaper and discussed international cooperation.They represented patient organisations,health-related nongovernmentalorganizations, clinical trial sponsors,pharmaceutical industry, ethics committees,regulatory authorities from allcontinents and intergovernmental organizations.In marketing authorization applicationssubmitted to the Agency between 2005310
WHO Drug Information Vol. 24, No. 4, 2010Recent Publications, Information and Eventsand 2009, only 38.8% of patients enrolledin pivotal clinical trials, received theirtreatments at clinical trial sites within theEU and EEA. These trials involved morethan 44 000 clinical trial sites in 89countries. The data generated was usedto support 347 marketing authorizationapplications as well as some applicationsfor a variation or a line extension of theexisting marketing authorization.References1. Draft Reflection Paper on Ethical and GoodClinical Practice (GCP) Aspects of ClinicalTrials of Medicinal Products for Human UseConducted in Third Countries and submitted inMarketing Authorization Applications to theEuropean Medicines Agency, at http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/06/WC500091530.pdf2. EMA Press Release, EMA/559074/2010, 6September 2010 at http:// www.ema.europa.euEvaluation of futurenanomedicinesEuropean Union — The EuropeanMedicines Agency (EMA) has hosted thefirst international scientific workshop onnanomedicines in September 2010.Some 200 European and internationalparticipants from 27 countries includingAustralia, Canada, India, Japan and theUnited States discussed benefits andchallenges arising from the application ofnanotechnologies to medicines. Participantsincluded representatives frompatient organizations, health care professionalorganizations, academia, regulatoryauthorities and the pharmaceuticalindustry.Nanotechnologies have a wide and stillonly partially exploited potential in thedevelopment of medicines. They providescope for engineered nano-systems thatcould lead to a spectrum of useful functionssuch as refined drug delivery,advanced combined diagnostics/therapeuticfunctions, matrices and supportstructures for regenerative medicines.Some eighteen marketing authorizationapplications for nanomedicines havebeen reviewed by the EMA so far.Emerging therapies give rise to questionson the appropriateness of current regulatoryframeworks, the relevance andadequacy of existing requirements andguidelines, and on the availability ofadequate expertise to regulators. Scientificchallenges arise from the limitationsof current testing methods and thereliability of novel ones, because of the‘nanosize’ and the unique behaviour ofsuch nano-systems in biological structures.Reference: European public assessmentreports for nanomedicines and presentationsof the keynote speakers at the workshop(EMA/567306/2010) at: http://www.ema.europa.euReporting on opioidinaccessibilityStrong opioids such as morphine arerarely accessible in low- and middleincomecountries, even for patients withthe most severe pain. The three casesrecently reported in the Journal of Painand Palliative Care Pharmacotherapyfrom three diverse countries provideexamples of the terrible and unnecessarysuffering that occurs everyday when thisessential, inexpensive, and safe medicationis not adequately accessible bypatients in pain. The reasons for this lackof accessibility are explored, and ways toresolve the problem are proposed.Reference: Krakauer EL, Wenk R, Buitrago R,Jenkins P, and Scholten W . Opioid inaccessibilityand its human consequences: ReportsFrom the Field. Journal of Pain and PalliativeCare Pharmacotherapy, 2010;24(3):239–243.311
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