... countries in Europe or elsewhere that join the Convention will be required, under Article 8(a)(i), to enact criminal offences against such unauthorised activities- thus making infringement a ...criminal matter. Because about 30% of generic drug launches infringe, to impose criminal liability-perhaps even imprisonment-will have a vast chilling effect on the generic drug industry.6 Second, the MEDICRIME Convention proposes to criminalise honest medicine manufacturers for unintentional mistakes.
The seriousness of this possibility raises the question of whether XDR-TB cases or outbreaks may constitute public health emergencies of international concern (PHEICs) under the 2005 International ...Health Regulations (IHR 2005), which became binding international law on June 15, 2007 2. ...as of June 15, 2007, States Parties must report such cases or outbreaks to WHO pursuant to the IHR 2005.
Migrant populations in high-income countries have faced myriad health and social inequities during the COVID-19 pandemic. Migrants often work in frontline essential services that expose them to ...COVID-19. Migrant workers in meat processing plants have endured large COVID-19 outbreaks across multiple countries.
We examine current scientific evidence around COVID-19 transmission, outcomes, and prevention for migrant workers and highlight meat processing plants as an example.
We performed a series of PubMed searches between January 1, 2020 and January 12, 2022.
Migrant workers in high-income countries often work in occupations at high risk for COVID-19 transmission, contract COVID-19 at higher rates, and experience worse outcomes than native-born counterparts. For example, meat processing plants represent almost ideal environments for rapid and large-scale SARS-CoV-2 viral transmission; often, large migrant workforces confined to small workspaces perform physically demanding work in noisy environments that require shouting to communicate, increasing workers' respiratory rates and the quantity of aerosolized droplets expelled and thus increasing viral transmission risk. Although enhanced vaccination outreach programs remain an important equity approach for migrant worker safety, they alone are insufficient. The emergence and rapid spread of multiple increasingly transmissible SARS-CoV-2 variants of concern with variable vaccine escape properties, including Omicron in November 2021, highlight the importance of improved infection prevention and control strategies to protect migrant workers. Across countries, strategies such as improving ventilation and mask quality in many high-risk occupational settings are already required by employment law. Universal mandatory vaccination program should also be considered.
COVID-19 transmission prevention for migrant workers requires an aggressive multicomponent plan that includes (a) improved on-site ventilation and infection prevention and control strategies; (b) improved social supports such as paid sick leave; (c) mobile vaccination clinics and community engagement to overcome vaccine hesitancy and barriers; and (d) consideration of universal mandatory vaccination programs.
Compulsory licensing has been widely suggested as a legal mechanism for bypassing patents to introduce lower-cost generic antiretrovirals for HIV/AIDS in developing countries. Previous studies found ...that compulsory licensing can reduce procurement prices for drugs, but it is unknown how the resulting prices compare to procurements through the Global Fund to Fight AIDS, Tuberculosis, and Malaria; UNICEF; and other international channels. For this study we systematically constructed a case-study database of compulsory licensing activity for antiretrovirals and compared compulsory license prices to those in the World Health Organization's (WHO's) Global Price Reporting Mechanism and the Global Fund's Price and Quality Reporting Tool. Thirty compulsory license cases were analyzed with 673 comparable procurements from WHO and Global Fund data. Compulsory license prices exceeded the median international procurement prices in nineteen of the thirty case studies, often with a price gap of more than 25 percent. Compulsory licensing often delivered suboptimal value when compared to the alternative of international procurement, especially when used by low-income countries to manufacture medicines locally. There is an ongoing need for multilateral and charitable actors to work collectively with governments and medicine suppliers on policy options.
Patent protection on medicines may frustrate access by blocking generic competition. Nevertheless, circumstances may still allow for generic procurement to occur anyway, especially for humanitarian ...cause. But to what extent does this occur? And which legal flexibilities may facilitate such procurement?
We attempted to design a replicable methodology that involved linking antiretroviral (ARV) patent data (1260 patents for 12 medicines) from a World Intellectual Property Organization patent study on the 2013 World Health Organization's (WHO) Model List of Essential Medicines to all available matching procurement records in the WHO's Global Price Reporting Mechanism. We then cross-referenced these with lists of legal flexibilities which facilitate generic access where patents have been granted (e.g., supplier companies' patent non-enforcement policies, voluntary and compulsory licenses) to estimate plausible relevance.
The patent data corresponded to 1924 generic procurement transactions (1.34 billion units) from 85 countries. While patents were relatively less common in these countries (the median coverage was 20%), over half (53%) of the generic procurements nevertheless aligned with patent protection in the exporting and/or importing country. The disproportionately high relevance of patents despite their lower numbers can be explained by their presence in key medicine-exporting countries and/or those with larger populations.
We noted, however, that developing countries still seemed able to buy generic versions of these essential ARVs. A combination of legal flexibilities may have played important roles, but voluntary licensing agreements (VLs) between originator companies and generic ones appeared to align with the largest volumes of generic procurement where we estimated patent protection. If true, VLs may warrant proportionate attention from observers as a heavily relied upon international mechanism for facilitating generic access so that the implications can be better understood; however, we hope others repeat similar studies to investigate whether these results hold with different methodologies and samples of patented medicines, contexts, and timeframes.
•While less common in lower-income countries, patents may be filed where medicine-exporters and large populations reside.•Thus, patents can have impact on importing countries’ medicine access, even when there is no patent domestically.•Yet, procurement of generic HIV medicines was still common when there appeared to be patents, at least within humanitarian context.•Voluntary licensing agreements (VLs) between originator and generic companies may have largely facilitated this.•If true, VLs may warrant proportionate attention from observers as a heavily relied upon mechanism for generic access.
Frontier injustice Houston, Adam R.; Attaran, Amir
Canadian journal of public health,
10/2019, Letnik:
110, Številka:
5
Journal Article
Recenzirano
Odprti dostop
“Import-from-Canada” strategies to address high prices for patented pharmaceuticals are gaining momentum in the United States. In the first two months of 2019 alone, five congressional bills ...incorporating such strategies were introduced; these bills have attracted bipartisan support across the fractious American political divide. At the same time, Canadian lawmakers continue their long-standing failure to take action in response to the looming threat of having Canada’s drug supply siphoned off by its more powerful neighbour. Unregulated bulk importation of pharmaceuticals originally intended for the Canadian market into the USA would lead to severe drug shortages that would undermine the Canadian health system, while also halting emerging moves towards universal Canadian pharmacare in their tracks. At the same time, this short-term approach to tackling American pricing woes would fail to heal the deep systemic issues that underpin unaffordable drug prices in the USA. This article underscores the need for Canada to take action to protect its supply of patented medicines, and suggests possible forms such action might take.
Les stratégies d’« importation du Canada » pour faire face aux prix élevés des produits pharmaceutiques brevetés prennent de l’ampleur aux États-Unis. Dans les deux premiers mois de 2019, cinq projets de loi du Congrès incorporant de telles stratégies ont été présentés; ces projets de loi ont attiré un soutien bipartite à travers le clivage politique hargneux des États-Unis. Parallèlement, les législateurs canadiens maintiennent leur inaction de longue date face à la menace imminente de voir l’approvisionnement des médicaments au Canada siphonné par son voisin plus puissant. L’importation en vrac non réglementée de produits pharmaceutiques initialement destinés au marché canadien aux États-Unis entraînerait de graves pénuries de médicaments qui compromettraient le système de santé canadien, tout en freinant l’évolution en cours vers un régime universel d’assurance-médicaments au Canada. En même temps, cette approche à court terme visant à résoudre les problèmes de tarification des États-Unis ne parviendrait pas à adresser les problèmes systémiques profonds qui sous-tendent les prix inabordables des médicaments aux États-Unis. Cet article souligne la nécessité pour le Canada de prendre des mesures pour protéger son approvisionnement en médicaments brevetés et suggère des formes possibles que pourraient revêtir de telles actions.
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