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Constitutional Law and Gender -- The role of the European Ombudsman in strengthening gender equality within the EU -- Mainstreaming Gender into Public Policies: A Tale of Two Countries -- Gender Pay Gap in the Western Balkans: Why Do Women Earn Less Than Men? -- Female Genital Mutilation as a Criminal Offence According to the Istanbul Convention -- On extreme forms of violence against women in Europe – Does femi(ni)cide exist in Germany? -- Femicide in Serbia – Inadequate Judicial Response -- The Importance of Having a Specific Stalking Law.

Prema preporukama Svjetske zdravstvene organizacije, agencije za lijekove osnovane su u većini država svijeta, a na tlu EU-a postoji i krovna Europska agencija za lijekove (engl. European Medicines Agency – EMA). Agencije usko surađuju s nositeljima odobrenja za stavljanje lijekova u promet u sklopu farmakovigilancijskog sustava. Obje institucije prate sigurnosni profil lijekova tijekom kliničkih ispitivanja i postmarketinške faze te izmjenjuju podatke o važnim pojedinačnim prijavama sumnje na nuspojave, ali i periodičke sinteze svih podataka prikupljenih u određenom razdoblju. Nositelj odobrenja dužan je pisati i predavati periodička izvješća o neškodljivosti lijeka (engl. Periodic Safety Update Report – PSUR), što se u EU-u zbiva prema zadanom rasporedu pa su EMA-i dostupne sve najnovije prikupljene sigurnosne informacije o pojedinom lijeku. Nacionalne agencije i EMA, koje predstavlja Povjerenstvo za ocjenu rizika na području farmakovigilancije (engl. Pharmacovigilance Risk Assessment Committee – PRAC), zajednički raspravljaju o signalima i sigurnosnim pitanjima vezanim uz omjer koristi i rizika od primjene lijeka, što katkad uključuje i arbitražne postupke (referrals) koji služe usuglašavanju o nužnim mjerama koje će biti poduzete u svim zemljama članicama jednako (npr. promjena informacija o lijeku). Nacionalne agencije putem svojih web-portala pružaju zdravstvenim djelatnicima odobrene i aktualne informacije o lijekovima kao što su Sažeci opisa svojstava lijeka, Upute o lijeku i mjere minimizacije rizika (npr., pisma zdravstvenim radnicima). Inspekcije na području farmakovigilancije koje provode agencije nad nositeljima odobrenja pregledavaju prostore, dokumentaciju, arhivu, Glavni spis o farmakovigilancijskom sustavu (engl. Pharmacovigilance System Master File – PSMF) i ispunjavanje obveza osoba odgovornih za farmakovigilanciju. ; Following regulatory recommendations from the World Health Organisation, all governments are responsible for the establishment of national medicines regulatory authorities (agencies). In the European Union (EU), national agencies closely collaborate with the European Medicines Agency (EMA). Agencies continue to cooperate with Marketing Authorisation Holders (MAHs) during the clinical research and postmarketing phase of a drug's life cycle. Information gathered from reported adverse drug reactions are interchanged between them. Periodic safety update reports (PSURs) in the EU are written and submitted by all MAHs according to a timetable brought by EMA. PSUR assessment is therefore comprehensive since it is done on up-to-date safety data collected for the particular drug. European national agencies and EMA, represented by Pharmacovigilance Risk Assessment Committee (PRAC), discuss various drug safety signals and issues in a procedure known as referral in order to make recommendations for a harmonised position across the EU (e.g. change of the product information). Web portals are tools widely used by the national agencies for communication with healthcare professionals. Up-to-date safety information and approved Summaries of Product's Characteristics (SPCs), Patient's Information Leaflets (PILs), and risk minimisation measures (such as Dear Healthcare Professional Communication, DHPC) are published there. Pharmacovigilance inspections are mostly focused on fulfilment of the requirements of premises, documentation, archives, Pharmacovigilance System Master File (PSMF) and compliance of the Qualified Person for Pharmacovigilance (QPPV).

This book offers a new perspective on public law and public policies. The collection of papers gathered here begins with an in-depth discussion on gender perspectives in constitutional law, which can support gender justice, but also perpetuate patriarchal norms. The book then analyzes the role of the European Ombudsman in the area of gender discrimination. Despite its limited jurisdiction, this institution has become a significant complementary tool in the protection of gender equality and the elimination of gender discrimination at the EU level. Particular attention is paid to the importance of mainstreaming gender into public policies. Thus, the legal and institutional frameworks of Spain and Serbia are presented, which can serve as an inspiration to other countries. Another important aspect covered in the book is an analysis of systemic differences between the average wages of women and men in the six countries of the Western Balkans. In turn, the book presents a discussion on female genital mutilation as a highly gendered crime based on extreme versions of rigid, patriarchal ethnic and religious norms and customs. It is analyzed through the lenses of the Istanbul Convention, as a tool for combating violence against women. Particular attention is paid to femicide, its definitions, forms, and phenomenological characteristics. Having been only recently acknowledged, femicide is still characterized by an inadequate judicial response in many countries. In this regard, a special focus is on German and Serbian experiences in acknowledging femicide and combating it through various measures. Finally, the importance of stalking laws is discussed, as stalking is a highly gendered crime that many states fail to combat adequately. The collection of essays offered in this book will be of interest to all those working in the field of public law, to policymakers, and to students and academics looking to broaden and deepen their research on various issues in public law and policies from gender perspectives.

Intro -- Preface -- Contents -- About the Editors -- Constitutional Law and Gender -- 1 Introduction -- 2 Constitutionalism in Context -- 2.1 From the Sexual Contract to Common Ground -- 2.2 Public Politics and Private Matters -- 2.3 Constitutionalism Beyond the Nation-State -- 2.4 Decorum, Abuse, Distress -- 3 Fundamental Rights -- 3.1 From Man to Human: The Legal Subject -- 3.2 Agency and Participation -- 3.3 From Pyramid to Triangle: Dignity-Liberty-Equality -- 3.4 From Formal to Substantive: Equality Revisited -- 3.5 From Essentialism to Intersectional Diversity -- 4 Foundational Structures -- 4.1 The Political Dimension: Democracy -- 4.2 The Legal Dimension: Rule of Law -- 4.3 The Social Dimension: Welfare State -- 4.4 The Material Dimension: Sustainability and the Environment -- 5 The Future: Constitutionalism Taking Gender into Account -- References -- The Role of the European Ombudsman in Strengthening Gender Equality Within the EU -- 1 Introduction -- 2 Guarantees of Equality Between Women and Men in EU Legislation -- 3 The Institution of the European Ombudsman -- 4 Gender Equality Cases in the European Ombudsman´s Practice -- 4.1 Sexual and Psychological Harassment -- 4.1.1 Prevention of Harassment -- 4.1.2 Dealing with Harassment -- 4.2 Pregnant Candidate Case -- 4.3 Gender Discrimination in Management Positions -- 4.4 Part-Time Work for National Experts -- 4.5 Paternity Leave -- 5 Conclusion -- Legal Documents, Internet Resources, and Cases -- References -- Mainstreaming Gender into Public Policies: A Tale of Two Countries -- 1 Introduction -- 2 Gender Mainstreaming in Spain and Serbia: History and Current Challenges -- 2.1 Spain -- 2.2 Serbia -- 3 Legislative and Institutional Frameworks for Gender Equality and Gender Mainstreaming -- 3.1 Spain -- 3.2 Serbia -- 4 Gender Mainstreaming Tools and Oversight -- 4.1 Spain -- 4.2 Serbia.

Following the adoption of the new Commission's Guidelines on rescue and restructuring, the authors take a closer look into the public authority's decision-making procedure to award restructuring aid. The analysis focuses on the national level of a decision-making process prior to the notification of restructuring aid to the Commission, using the example of the Republic of Croatia. The authors question the national procedure(s), its transparency and the margins of State's discretionary power to decide if and who to award the restructuring aid and initiate the procedure before the European Commission. It is being argued that the wider the discretionary power of the competent authorities who grant restructuring aid, the wider is the potential of negative social, financial and market-wise consequences both for the State as well as the recipient undertaking. In order to avoid worst possible scenario, the authors suggest de lege ferenda proposal of the assessment criteria.