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Introduction: Hindsight bias is the tendency to estimate an outcome once it is known. Legal systems are often prone to hindsight bias. In patent law, the non-obviousness or inventive step is the most critical determinant of patentability and often subjected to hindsight bias.Areas covered: Scholarly literature confirms the existence of hindsight bias in different patent systems. This communication hence addresses factors, which lead to hindsight bias specifically in chemical and pharmaceutical arts, guidance from the case law that can be helpful in avoiding hindsight bias in non-obviousness determination.Expert opinion: The Supreme Court in 2007, advocated a more expansive and flexible approach to where the Teaching Suggestion or Motivation test could come from. In the case of chemical and pharmaceutical active compounds, the considerations such as i) was there sufficient motivation to modify the lead compound and arrive at the claimed compound and its properties, ii) was there a reasonable expectation of success to achieve the claimed property and other such considerations highlighted in this review may contribute to avoid hindsight bias in non-obviousness determination.

The use of new approach methodologies (NAMs) in support of read-across (RAx) approaches for regulatory purposes is a main goal of the EU-ToxRisk project. To bring this forward, EU-ToxRisk partners convened a workshop in close collaboration with regulatory representatives from key organizations including European regulatory agencies, such as the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), as well as the Scientific Committee on Consumer Safety (SCCS), national agencies from several European countries, Japan, Canada and the USA, as well as the Organisation for Economic Cooperation and Development (OECD). More than a hundred people actively participated in the discussions, bringing together diverse viewpoints across academia, regulators and industry. The discussion was organized starting from five practical cases of RAx applied to specific problems that offered the oppor-tunity to consider real examples. There was general consensus that NAMs can improve confidence in RAx, in particular in defining category boundaries as well as characterizing the similarities/dissimilarities between source and target substances. In addition to describing dynamics, NAMs can be helpful in terms of kinetics and metabolism that may play an important role in the demonstration of similarity or dissimilarity among the members of a category. NAMs were also noted as effective in providing quanti-tative data correlated with traditional no observed adverse effect levels (NOAELs) used in risk assessment, while reducing the uncertainty on the final conclusion. An interesting point of view was the advice on calibrating the number of new tests that should be carefully selected, avoiding the allure of \"the more, the better\". Unfortunately, yet unsurprisingly, there was no single approach befitting every case, requiring careful analysis delineating the optimal approach. Expert analysis and assessment of each specific case is still an important step in the process.

Ten years after the enactment of the Biologics Price Competition and Innovation Act (BPCIA), competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration (FDA) evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics\' manufacturing information available to follow-on manufacturers. As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics is difficult and expensive, if not outright impossible. This is expected to be especially true for the highly anticipated class of interchangeable biologics, none of which has been approved by the FDA to date. Yet, it has long been the position of the brand-name pharmaceutical industry (Industry) that biologics manufacturing information is proprietary and, thus, may not be shared. Congress has subscribed to the Industry\'s position, prohibiting the FDA from disclosing regulatory filings submitted by developers of original biologics, including manufacturing information, to third parties. That prohibition not only undermines competition in biologics markets, but is also wasteful, potentially unethical, and poses unnecessary risks to the health and safety of patients. This article makes the case for FDA sharing of original biologics manufacturing information with follow-on biologics developers. It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which is administered by the Environmental Protection Agency (EPA). The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets.

Regulatory capture describes the phenomenon in which regulators (e.g. medical agencies) protect the interest of the companies they regulate rather than the interest of the public. Not much is known about the mechanisms of this potential threat within the area of pharmaceutical regulation.
Through a comparison of two EU member states, the Netherlands and Denmark, this study aimed to investigate how regulatory capture could exist in pharmaceutical regulation. The EU Falsified Medicines Directive was used as the case, as it provided an opportunity for national medicine agencies to interact with various stakeholders.
The processes of negotiation and implementation of the directive were mapped by interviewing 23 stakeholder representatives and triangulated with relevant documents. A meaning condensation method was applied to show how stakeholders were involved with authorities, and the theory of regulatory capture was used to interpret how the two countries were susceptible to capture.
The Danish Medical Agency was central in all relevant processes, whereas in the Netherlands, the Ministry of Health initiated the processes during the negotiation phase and, subsequently, three medical agencies shared responsibilities in the implementation phase. During the negotiation phase, the Dutch process was more focused on consensus among stakeholders while the Danish process focused on preparing the subsequent implementation. Neither member state prioritised transparency during implementation, but rather focused on timely implementation.
The processes of EU negotiations and implementation of the Falsified Medicines Directive were handled quite differently in Denmark and the Netherlands. It is possible that regulatory capture could be prevalent in both member states as policy makers were only in limited dialogue with patients. EU countries must decide whether this technocratic approach is acceptable, or whether they should make a more concerted effort to include the public.

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Cannabis policies should be relevant to communities most impacted by them. Home cultivation policies can engage people who grow cannabis and build on their motivation to supply a safe product. This paper aims to examine the laws pertaining to \"home\" (i.e. personal, small-scale) cannabis cultivation internationally and their different aspects, and to discuss the potential of these policies to be expanded into community-level cannabis supply models.
We reviewed relevant laws and regulations in states/countries that legalised, decriminalised or applied other non-prohibitive approaches to home cannabis cultivation.
Non-prohibitive approaches to home cannabis cultivation have been adopted in at least 27 jurisdictions. Twelve jurisdictions \"de jure\" legalised home cultivation (three U.S. states and Antigua and Barbuda legalised only home cultivation; six U.S. states, Uruguay and Canada legalised commercial sales as well). Eight states/countries \"de facto\" (Belgium, the Netherlands) or \"de jure\" decriminalised it (Czech Republic, Spain, Jamaica, and three Australian states). \"De jure\" depenalisation was in place in Chile and Brazil and recent court rulings yielded \"de facto\" depenalisation or \"de facto\" legalisation in five other jurisdictions (South Africa, Mexico, Colombia, Costa Rica and Georgia). Varying number of plants (per person and per property) and the circumstances of cultivation were in place. The key limitations of the regulations included (i) possession thresholds for the produce from home cultivations, (ii) rules about sharing the produce, and (iii) potentially disproportionate sanctions for non-authorised behaviours. Despite currently being limited, home cultivation policies might have the capacity to engage cannabis networks that already exist in the community and like that, enhance their participation in legitimate policy schemes.
Rules around pooled cultivation and sharing could be made fit for purpose to accommodate community supply of cannabis. Home cultivation policies could serve as a basis for community-level cannabis supply models and as such, for more inclusive cannabis policies.

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