Quick Guide to Market Access in the Latin America Healthcare and Life Sciences Sector
钱伯斯(Baker McKenzie)· 2025-01-04 04:58
Industry Overview - The Healthcare and Life Sciences industry in Latin America is highly regulated, with a focus on price control mechanisms, public health system access, and private healthcare plan regulations [2] - The report covers key markets including Argentina, Brazil, Chile, Colombia, Mexico, Peru, and Venezuela [2] Argentina - Marketing Authorization holders can set pharmaceutical prices but must inform ANMAT's registry [5] - In 2020, authorities regulated the price of a specific orphan drug and froze prices of certain pharmaceuticals to prevent inflation-driven increases [5] - Health insurance providers are subject to strict regulations, including minimum mandatory coverage, with courts sometimes requiring specific treatments to be included [6] - ANMAT grants import and manufacturing licenses, controls GMP adherence, and grants marketing authorizations [7] - CONETEC evaluates and issues recommendations on health technologies for incorporation into the health system [7] Brazil - CMED sets drug price limits, stimulates competition, and applies penalties for violations [13] - Innovative drugs are subject to international price comparison, while generics must be at least 65% of the reference drug price [13] - SUS drugs are selected and standardized in the National Essential Medicines List, with CONITEC evaluating and recommending drugs for incorporation [14] - ANS regulates private health plans and incorporates technologies recommended by CONITEC after March 2022 [15][16] Chile - There are no price controls for pharmaceuticals, but proposed Pharmacy Law II may introduce them [20] - The Ministry of Health updates the National Formulary with advice from a Technical-Scientific Commission [21] - Access to private health plans is not regulated, and there is no minimum coverage [19] Colombia - CNPMDM controls prices, with a supervised freedom regime for most medicines and direct control for specific ones [24] - The public health system is divided into Subsidized and Contributory regimes, with the Ministry of Health determining covered medicines and services [25] - Private health plans are regulated by the Superintendent of National Health and the Financial Superintendence [28] Mexico - Pricing in the private market depends on patent protection, with international price referencing for patented products [31] - The National Formulary of Medical Products is managed by a Commission, with additions requiring economic evaluation studies and binding price letters [32] - Access to private health plans is not regulated, and only a small percentage of the population has access [33] Peru - There are no pharmaceutical price regulations [36] - The Essential Health Insurance Plan (PEAS) specifies minimum benefits for public, private, or mixed health insurance [37] - The Ministry of Health reviews and updates the Single National Petition for Essential Medicines (PNUME) [38] Venezuela - The Fair Price Law allows a maximum profit margin of 30%, but enforcement has been absent for the last three years [41] - The Ministry of Health and SUNDDE are responsible for applying the Fair Price Law [41] - Health insurance policies are regulated by the Insurance Activities Law, which does not provide for mandatory minimum coverage [42]
Regulations on the Status and Transfer of Players - January 2025 edition
FIFA· 2024-12-24 01:48
Industry Investment Rating - The report does not explicitly provide an industry investment rating [1] Core Viewpoints - The report focuses on regulations governing the status and transfer of players, including contracts, third-party influence, and special provisions for female players and minors [4][7][32] - It emphasizes the importance of maintaining contractual stability between professionals and clubs, with specific rules for terminating contracts and compensation [13][14][17] - The report outlines the procedures for international transfers, including the use of the Transfer Matching System (TMS) and training compensation mechanisms [48][57][79] Third-Party Influence and Ownership - Clubs and players are prohibited from entering agreements with third parties that allow participation in future transfer compensation [19] - Existing agreements must be recorded in TMS by the end of April 2015, with full details of the third party, player, and agreement duration [20] Special Provisions for Female Players - Contracts cannot be invalidated based on pregnancy, adoption, or family leave [8] - Clubs must respect female players' rights related to menstrual health, allowing absence from training or matches with full remuneration [31][521] International Transfers Involving Minors - Minors can only be transferred under specific exceptions, such as transfers within the same country or for academic reasons [34][37] - Clubs must provide adequate football education and living standards for minors [11][35] Training Compensation and Solidarity Mechanism - Training compensation is payable when a player is registered as a professional for the first time or transferred before the age of 23 [79] - The solidarity mechanism requires 5% of transfer compensation to be distributed to clubs involved in the player's training [396] Jurisdiction and Dispute Resolution - FIFA has jurisdiction over employment-related disputes between clubs and players of international dimension [29][57] - The Football Tribunal can impose sanctions for breaches of contract, including registration bans and fines [24][466] Annexes and Additional Provisions - Annexes cover the release of players to association teams, employment of coaches, and international transfer procedures [92][170][208] - Temporary rules address the exceptional situation deriving from the war in Ukraine [269]
Community engagement in the Middle East
理特咨询· 2024-12-23 00:53
VIEWPOINT AUTHORS C O M M U N I T Y E N G AG E M E N T I N THE MIDDLE EAST Despite economic shocks and geopolitical turbulence, the Middle East is still among the world's fastest-growing regions. As urbanization accelerates, Middle Eastern (ME) states need to incorporate good sustainability practices to ensure they can meet their ambitious development goals, especially when it comes to community engagement and capacity building. Yet simply copying Western approaches is not enough. To be successful, develope ...
Circular 1915_FIFA Compliance Summit 2025
FIFA· 2024-12-21 01:48
TO THE MEMBER ASSOCIATIONS OF FIFA 5 th FIFA Compliance Summit – 9-10 April 2025 Dear Sir or Madam, Next year's summit will be broader in scope than previous editions and aims to support our 211 member associations even more effectively. The event programme will cover key compliance areas, including compliance programme development, governance, risk management and internal audit practices. Through a combination of presentations and interactive workshops, we will explore these topics in depth, offering pract ...
Open digital architecture: The next frontier for telecom operators
理特咨询· 2024-12-21 00:53
Industry Investment Rating - The report highlights Open Digital Architecture (ODA) as a transformative trend in the telecom industry, positioning it as a key enabler for growth and innovation [55][56][57] Core Viewpoints - ODA represents a fundamental shift for telecom operators, enabling faster innovation, cost efficiencies, and customer-centric business models [3][7][25][34] - The adoption of ODA will allow CSPs to transition from asset-centric to solution-centric organizations, with greater flexibility in product and service offerings [3][7][74] - ODA's modular and interoperable nature reduces vendor lock-in, lowers innovation costs, and accelerates time-to-market for new services [61][74][75] - The integration of 5G, edge computing, AI, and IoT will drive ODA adoption, enabling CSPs to offer faster, more reliable, and innovative services [32][68][97] Key Benefits of ODA - **Cost Efficiencies**: ODA reduces the cost of innovating on CSP tech stacks through automation, shorter development times, and universal design principles [25][61][77] - **Faster Deployment**: ODA's cloud platform allows for faster and less expensive deployment and scaling of new propositions [75][112] - **Customer-Centricity**: ODA enables CSPs to offer tailored services and packages, improving customer experience and capturing more value [34][76][92] - **Business Model Innovation**: ODA facilitates the creation of new business models and revenue streams through its flexible and modular architecture [60][76][86] Challenges and Risks - **Security Risks**: ODA increases the attack surface for CSPs, making cybersecurity a critical consideration during the transition [27][64][65] - **Migration Risks**: Integrating legacy systems with ODA can lead to compatibility issues, data migration hurdles, and unforeseen costs [67][77] - **Cultural Change & Skills Gap**: Transitioning to ODA requires proficiency in cloud-native technologies and API management, necessitating investment in training and recruitment [30][83][106] - **Regulatory Compliance**: The telecom industry's stringent regulatory environment demands rigorous adherence to data protection, privacy, and security standards [47][80] Strategic Recommendations for CSPs - **Embrace Innovation**: Actively adopt ODA-related technologies to stay competitive and enhance customer experience [37][101] - **Prioritize Customer-Centricity**: Tailor services based on deep customer insights and data analytics [92][101] - **Drive Operational Excellence**: Continuously optimize processes and infrastructure using agile methodologies [50][103] - **Form Strategic Partnerships**: Collaborate with vendors and partners to access cutting-edge technologies and capabilities [38][103] - **Invest in Workforce Development**: Equip employees with the necessary skills and foster a culture of continuous learning and collaboration [106][103] Future of ODA - ODA is expected to become an industry standard, driven by technological advancements, industry collaboration, and evolving customer expectations [97][100] - The competitive landscape will shift with new market entrants, disruptive business models, and increased focus on differentiation and value-added services [86][97] - CSPs must adapt to the evolving ODA landscape by focusing on innovation, customer-centricity, operational excellence, and strategic partnerships [110][93]
Disclosure and Target Setting in the Agriculture Sector
RMI· 2024-12-21 00:18
Machinery Manufacturing The energy consumed due to the manufacturing of machinery is comparable to the fuel energy consumed during farm field work but has been falling due to the increased amounts of recycled steel being used in machinery manufacturing.30 In this analysis of farm machinery manufacturing, the focus is the manufacturing of tractors, not only because they provide the power for most on-field operations, but also because they require more energy during manufacturing than most other farm equipmen ...
WHO Global Infection Prevention and Control Network meeting, 30 October 2024
世界卫生组织· 2024-12-20 01:50
Overview of World Hand Hygiene Day (WHHD) and proposed themes Ms Mandy Deeves, Technical Officer, IPC Technical and Clinical Hub and Task Force, WHO HQ 6 The meeting focused on discussing the WHHD theme for 2025, Save Lives. Clean Your Hands Campaign, marking its 17th year in 2025. A brief introduction highlighted the purpose of the meeting and the campaign's ongoing mission to promote global hand hygiene in healthcare. The discussion was intended to generate feedback on theme proposals for 2025, many of wh ...
The Best FIFA Women’s Coach 2024
FIFA· 2024-12-20 01:48
FIFA FOOTBALL AWARDS FIFAWOMEN'S COACH THE vJ - l t VOTING RESULTS | --- | --- | --- | --- | --- | --- | --- | |-------|------------------|-------------------|--------------------|-----------------|----------------|-------------------| | RANK | NAME | COACHES (POINTS)* | CAPTAINS (POINTS)* | MEDIA (POINTS)* | FANS (POINTS)* | SCORING POINTS** | | 1 | Emma Hayes | 545 | 634 | 584 | 162,577 | 23 | | 2 | Jonatan Giráldez | 465 | 404 | 452 | 252,713 | 20 | | 3 | Arthur Elias | 170 | 122 | 159 | 252,796 | 13 | * ...
The Best FIFA Women’s Player 2024
FIFA· 2024-12-20 01:48
FIFA WOMEN'S PLAYER ... GOAL!!! 9 C 1 - 12 % -250 T THE n l | --- | --- | --- | --- | --- | --- | --- | |-------|-------------------------|-------------------|--------------------|-----------------|----------------|-------------------| | RANK | NAME | COACHES (POINTS)* | CAPTAINS (POINTS)* | MEDIA (POINTS)* | FANS (POINTS)* | SCORING POINTS** | | 1 | Aitana Bonmatí | 608 | 489 | 641 | 594,097 | 52 | | 2 | Barbra Banda | 172 | 247 | 111 | 140,694 | 39 | | 3 | Caroline Graham Hansen | 128 | 171 | 203 | 111,87 ...