Challenges for Intellectual Property Management of HIV Vaccine-Related Research and Development: Part 2, The Canadian Context
Notice bibliographique
Résumé
On 20 February 2007, Prime Minister Stephen Harper announced a commitment by the Government of Canada and the Bill & Melinda Gates Foundation to fund and support the Canadian HIV Vaccine Initiative (CHVI), (1) an effort to accelerate the development of an HIV/AIDS vaccine and address critical research gaps identified by the Global HIV/AIDS Vaccine Enterprise (GHAVE). (2) The goal of the CHVI is to coordinate research within Canada as well as Canadian contributions to the international efforts to develop safe, effective, affordable, and globally accessible vaccines. (3) Canada's commitment to HIV vaccine research is longstanding. In 2002, Canada promised at the XIV International AIDS Conference, held in Barcelona, to develop a Canadian HIV/AIDS vaccine plan focusing vaccine production and equitable distribution ... this plan will support the global vaccine effort and will contribute to a better understanding of the complex legal, ethical and human rights issues involved in addressing access to vaccines and treatments for people living with HIV/AIDS, nationally and globally. (4) The Canadian HIV Vaccines Plan: Towards a World Without AIDS was published in 2006, (5) and calls for Canada to contribute towards global efforts to develop and deliver HIV vaccines, including strong community-based organizations; a strong research capacity; immune-monitoring capability; long-term relationships with research partners in the developing world; infrastructure in Canada and internationally; recognition of our strengths in social science, legal issues and human rights; new possibilities for production plants; emerging private-public sector partnerships; international recognition for diplomacy; and a strong health care ... system. (6) To accomplish these goals, it is necessary to ascertain and respond to the key non-science challenges to HIV vaccine research in Canada, focusing on any potential intellectual property (IP) bottlenecks. This paper builds upon the key issues identified in Part One of this series of two papers on Challenges for Intellectual Property Management of HIV Vaccine-Related Research and Development [hereinafter, Part One]. Following that review of the global literature and consultations with international experts, (7) we consulted with representatives from the CHVI and developed sector-specific interview guides for academic researchers, government, and industry representatives in Canada. We conducted individual or group interviews with 21 key informants in Canada, including CHVI representatives, experts in intellectual property law, management and ethics, as well as academic and private sector HW vaccine researchers. (8) Here, we present the conclusions from those interviews, a discussion of key concerns, and potential solutions. The consultations focused on the main non-science barriers to HIV vaccines (R&D) in Canada. The main challenges identified from a research perspective surprisingly did not include issues related to IP, but were, instead, inadequate funding for research, clinical trials and gap funding for taking innovative research to the proof of principle stage. There are also problems associated with the creation of effective research networks and collaborative models. Further downstream, there will be major challenges associated with manufacturing and distributing vaccines, particularly in developing countries, and the associated risks of liability for adverse events, such as allergic reactions to the vaccine. This latter issue has already come to the fore in HIV vaccine clinical trials known as the Step Study. The vaccine, manufactured by Merck and Co., was found to increase the susceptibility of participants to HW infection if they had high levels of antibodies to adenovirus 5. Adenovirus 5 was a component of the vaccine and is one of the causes of the common cold. Indeed, an independent Data and Safety Monitoring Board went so far as to recommend unblinding the results and notifying participants whether they received the Merck vaccine or the placebo. …
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,101 | 0,150 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,002 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,010 | 0,012 |
| Études des sciences et des technologies | 0,037 | 0,050 |
| Communication savante | 0,061 | 0,021 |
| Science ouverte | 0,011 | 0,014 |
| Intégrité de la recherche | 0,033 | 0,027 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,016 | 0,002 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».