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BACKGROUND: The COVID-19 pandemic has increased the interest in the right to health, which represents a relatively new concept brought about by progress in medical science and the evolution of societies. The Italian Constitution, in article 32, states the right to health without specifications about the parameter of sex, assuming that this fundamental right is property of women and men indiscriminately. OBJECTIVE: To assess whether the right to health has actually been achieved in an equal way from the standpoint of sex, and whether a hypothetically "neutral" approach is actually convincing and profitable in this context. METHODS: This paper analyzes the topic of gender medicine from a scientific and legal perspective, based on current medical literature and its implementation in the Italian and European legal systems. RESULTS: Gender medicine is the only credible response to sex- and gender-based inequalities affecting the right to health, as it provides tools to address persisting inequalities in prevention and treatment, thus pursuing health for all: women and men. CONCLUSIONS: The importance of this path was underlined also by the Summit and the Rome Declaration of 21 May 2021, acknowledging that the topic of sex and gender can no longer be overlooked in focusing a correct and equal healthcare approach. [ABSTRACT FROM AUTHOR]

BACKGROUND: In the COVID-19 pandemic, coordination was certainly late, also due to the scarcity of information disseminated at the very beginning of the pandemic, when countries were inevitably taken by surprise. The lack of information, mainly attributable to the country from which everything seems to have started, has produced a huge delay and numerous uncertainties in the feedback of the WHO and international organizations. OBJECTIVE: The inevitably relevant issue, from a legal point of view, concerns the legitimacy, formal or in any case shared, of the authority in charge of coordinating reactions and policies. The paper analyses the current legislation, soft and hard law, and the undertaken policies concerning emergency responses. METHODS: International and EU legislation analysis. RESULTS: The G20 understood that sustainable, flexible and agile funding systems for health emergencies are essential elements of pandemic prevention, preparedness and response. In EU there are many regulations about coordination and response to emergencies in practice in the EU and the Regulation (EU) 2021/522 (EU4Health programme), broadly extends the Union's competence in the field of health and has the objective of strengthening the Union's capacity for prevention, preparedness and rapid response in the event of serious cross-border threats to health. CONCLUSIONS: It is essential to formalize, within international agreements, the institutionalization of relationships, procedures, and the possible recognition of the reference figure. If in the European Union, at least partially, the protocols are there (even if the COVID-19 emergency has blown them up in principle), certainly in relations with non-EU countries the story is complicated, requiring specific agreements. This is the goal of the path started by the Rome Declaration of 21 May 2021 within the G20 – Global Health Summit. [ABSTRACT FROM AUTHOR]

BACKGROUND: The health emergency provoked by the worldwide pandemic requires immediate action to achieve the immunization of the population and to stop further contagion. The systems of public procurement needed to adapt in a very short time to reach agreements with the pharmaceutical industry. OBJECTIVE: Proposing options between the waiving of patent protections and innovative public procurement, principally the European Advance Purchase Agreements (APA). METHODS: A description of the actual situation and the necessary regulatory reforms. The sources are scientific articles, legislative compendiums and opinion pieces and the current press. RESULTS: The debate over the waiving of patent protections at this time is both misleading and ineffective due to the economic and legal problems involved. The path of the APA has proven to be very effective, although some deficits should be corrected, principally regarding questions of transparency and confidentiality. CONCLUSIONS: Among the possible options for the acquisition of the COVID-19 vaccine and its universal access, agreements and cooperation between States and innovative industry are desirable. One successful path is that of the advance purchase agreements utilized by the European Union, another could be that of voluntary licensing. We propose following these routes as opposed to the waiving of patent protections. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To study the drop-out rates in trials of selective serotonin and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs). METHODS: This study is a systematic review and meta-analysis of trials. The main outcome measure: Overall drop-out rate. Secondary outcomes were drop-outs due to adverse events and lack of effect. We obtained clinical study reports (CSRs) of five antidepressant drugs from the European Medicines Agency and the UK's Medicines and Healthcare products Regulatory Agency. The eligibility criteria for selecting studies: double-blind randomised, placebo-controlled trials for any indication. Data extraction and analysis: The primary outcome was extracted by two researchers independently and meta-analysed using the Mantel-Haenszel method (fixed effect model). The secondary outcomes were extracted by one researcher and checked by another. Sensitivity analyses were performed using Peto's odds ratio and beta binomial methods, due to presence of null events, and by excluding unreliable trials. RESULTS: We included 71 CSRs (67,319 pages) with information on 73 trials (11,057 patients on SSRI or SNRI drugs, and 7,369 on placebo). There were minor discrepancies within the CSRs when a modified intention to treat principle was used and patients lost to follow up early in the trial were not accounted for. Significantly more patients dropped out on active drug than on placebo, risk ratio 1.08 (95% CI 1.03 to 1.13), with no difference between adults and children/ adolescents, RR = 1.08 (1.03 to 1.13) and 1.07 (0.95 to 1.21), respectively. When three trials with a prior single-blind phase on active drug were removed, the difference was a risk ratio of 1.12 (1.07 to 1.18), whereas the result was the same after removal of three trials with fraudulent data or other issues with data validity, risk ratio 1.08 (1.03 to 1.13). There were more drop-outs due to adverse events on active drug than on placebo, risk ratio 2.63 (2.33 to 2.96). There were fewer drop-outs due to lack of effect, risk ratio 0.47 (0.43 to 0.53). However, this result is biased; when more people drop out due to adverse effects, fewer can drop out because of lack of effect. CONCLUSIONS: By using CSRs, we were able to demonstrate for the first time that more patients dropped out on active drug than on placebo. As it can be argued that the drop-out rate reflects the patients' overall assessment of the balance between benefits and harms, our review adds to the growing concern that SSRIs and SNRIs might not have the desired effect. Our review also highlights the importance of using CSRs for undertaking reviews of drugs. [ABSTRACT FROM AUTHOR]

BACKGROUND: Regulatory decision for withdrawal of a drug from market in European Union (EU) or other developed countries poses a challenge to authorities in developing countries specially when decision varies from different countries, such as for nimesulide. OBJECTIVES: To compare and evaluate, benefit and risk data for regulatory action, of nimesulide in India and EU. METHODS: Data on Nimesulide from EU available from Report on EMA website and Indian data from published literature (SCOPUS data base), WHO Vigibase and International Medicines Statistics (IMS) was compared. RESULTS: Publications from India on Adverse drug reactions (ADRs) are case reports (10) and case series (14). Drug Utilization Research (DUR) studies (17) are mostly from tertiary centres. Data in the WHO Vigibase is meagre, data from IMS is not easily available and there is regional variation in prescriptions. Thus incidence of ADRs per sale, prescription or defined daily does (DDD) cannot be calculated, as has been done for EU. CONCLUSION: Limited and varying data in post marketing studies on ADRs and drug utilization for nimesulide from India made regulatory decision difficult. India and other similar countries could contribute to post marketing data for local and global regulatory decisions by systematically planned studies and networking within country and across countries in region. [ABSTRACT FROM AUTHOR]

Examines the provision of low cost medicines in transitional countries. Differences within countries in terms of health status and access to health services; Overview of the drug market in Central Europe and Eastern Europe; Reason for the increase in private spending and greater co-payments for reimbursable drugs.

The article deals with the need to provide relevant health information to citizens in Europe. A joint declaration on the provision of relevant health information to citizens has been endorsed by Health Action International Europe, the International Society of Drug Bulletins, the Association Internationale de la Mutualité, the Bureau Européen des Unions de Consommateurs and the Medicines in Europe Forum. They have also called for a clear distinction between information and advertising disguised as information.