Enregistrement - Lobbyistes salariés d'entreprises

Objets

• Affaires autochtones
• Agriculture
• Commerce intérieur
• Commerce international
• Défense
• Développement économique
• Développement régional
• Éducation
• Emploi et formation
• Énergie
• Environnement
• Immigration
• Impôts et finances
• Industrie
• Infrastructure
• Institutions financières
• Justice et application des lois
• Marchés publics
• Petites entreprises
• Propriété intellectuelle
• Questions constitutionnelles
• Questions touchant les consommateurs
• Recherche et développement
• Relations internationales
• Santé
• Sciences et technologies
• Sports
• Télécommunications
• Tourisme
• Transports
• Travail

Détails sur l'objet

Politique ou Programme

• Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility". Merck is seeking to ensure Canada's continued compliance with its obligations under TRIPs relevant to the biopharmaceutical industry within all domestic legislation in addition to ongoing and future trade negotiations. Relevant domestic legislation includes the Food and Drugs Act, the Patent Act, and related regulations and guidance documents. Beyond TRIPs, Merck is seeking enhancements to increase the stability and global competitiveness of Canada’s intellectual Property legislation, regulations and policies relevant to the biopharmaceutical industry. Such enhancements may result from domestic policy in addition to bilateral and multilateral trade negotiations (e.g. Comprehensive Economic and Trade Agreement (CETA) and the Trans-Pacific Partnership (TPP).
• Anti-Counterfeit Trade Agreement (ACTA) as it concerns counterfeit drugs.
• Any and all free trade treaty agreements as it relates to the North American Free Trade Agreement (NAFTA) and trade negotiations between Canada as it relates to the European Union, India, Japan and the Trans-Pacific Partnership. International trade policies in support of the biopharmaceutical industry, including competitive and predictable intellectual property protection, product regulation and patient access to medicines.
• Canada's Access to Medicines Regime with respect to ensuring that the program allows for the delivery of timely access to needed medicines to the developing world supported by a business climate in Canada that continues to encourage research into further treatment and prevention of disease.
• Canadian Institutes of Health Research (CIHR) Clinical Research Initiatives as it relates to public/private research and development partnerships and to the Drug Safety and Effective Network (DSEN).
• Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework.
• Establish accountability with the federally financed Canadian Agency for Drugs and Technologies in Health (CADTH).
• Federal Government involvement in national strategies to address major chronic diseases having a significant burden on the Canadian health care system, such as Dementia, Diabetes, Hepatitis C and Cancer and major public health concerns such as Antimicrobial resistant.
• Health Canada's Legislative and Regulatory Modernization (LRM) as it relates to the review, approval, transparency and compliance activities of biopharmaceutical products. Health Canada's Regulatory Roadmap for Health Products and Food as it relates to proposed policy and regulatory changes related to the review, approval, transparency and compliance activities of biopharmacuetical products.
• National Pharmaceutical Strategy as it relates to the federal government's involvement in federal/provincial access to medicines framework.
• Partnership opportunities as it relates to Canada's policy and programs to improve health in the developing world, such as Maternal and Child Health.
• Pharmaceutical pricing policy issues arising from the jurisdiction of the Patended Medicines Prices Review Board (PMPRB) and R&D reporting.
• Plan design and reimbursement policies for drug plans administered by Federal Government including NIHB and Corrections Services.
• Policies and programs as it relates to vaccine approval, procurement and public awareness of immunization.
• Scientific Research and Educational Design (SR&ED) Tax Credit in respect of updating the system and increasing the expenditure limit for refundable credits.
• Subsequent Entry Biologics (SEBs) as it relates to Regulations, Policies, or Guidelines being developed by Health Canada, specifically the Draft Guidance Document on SEBs, the Notices of Changes to Health Canada's Guidance Documents on Data Protection and Patented Medicines Regulations (Notice of Compliance) Regulations.
• The government's Science and Technology strategy as it relates to the biopharmaceutical industry.
• US - Canada Regulatory Cooperation Council (RCC) as it relates to the regulation of biopharmaceutical products.
• World Health Organization issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernment Working Group (IGWG).

Proposition législative, Projet de loi ou résolution

• Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry, and related updates and to Federal budgetary policy.
• Income Tax Act as it relates to biopharmaceutical products.
• Patent Act as it relates to reporting requirements and pricing guidelines, and the protection of intellectual property in biopharmaceutical products.

Proposition législative, Projet de loi ou résolution, Règlement

• Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies.
• Food and Drugs Act and Regulations and the Import and Export Permits Act with respect to cross-border trade as it relates to the export of Canadian biopharmaceuticals.

Règlement

• Food and Drug Regulations as it relates to data protection and the regulation and protection of biopharmaceutical products.
• New Substances Notification Regulations as it relates to the biopharmaceutical industry.
• Patented Medicines (Notice of Compliance) Regulations as it relates to the regulation of intellectual property for biopharmaceutical products.
• Patented Medicines (Notice of Compliance) Regulations with respect to ensuring that patent rights are respected and are internationally competitive.
• Patented Medicines Regulations as it relates to the regulation and protection of biopharmaceutical products.
• Smart Regulations as it relates to the biopharmaceutical industry.

Techniques de communication

• Communication écrite
• Communication orale

Institutions gouvernementales

• Affaires autochtones et du Nord Canada
• Affaires mondiales Canada (AMC)
• Agence de la santé publique du Canada (ASPC)
• Agriculture et Agroalimentaire Canada (AAC)
• Anciens Combattants Canada (ACC)
• Bureau du Conseil privé (BCP)
• Cabinet du Premier ministre (CPM)
• Chambre des communes
• Commissariat à l'information du Canada (CI)
• Commissariat à la protection de la vie privée du Canada (CPVP)
• Conseil d'examen du prix des médicaments brevetés (CEPMB)
• Conseil de recherches en sciences naturelles et en génie (CRSNG)
• Conseil national de recherches (CNRC)
• Emploi et Développement social Canada (EDSC)
• Environnement et Changement climatique Canada (ECCC)
• Finances Canada (FIN)
• Innovation, Sciences et Développement économique Canada (ISDE)
• Instituts de recherche en santé du Canada (IRSC)
• Justice Canada (JC)
• Pêches et Océans Canada (MPO)
• Ressources naturelles Canada (RNCan)
• Santé Canada (SC)
• Secrétariat du Conseil du Trésor du Canada (SCT)
• Sécurité publique Canada (SP)
• Sénat du Canada
• Services publics et Approvisionnement Canada (SPAC)
• Statistique Canada (StatCan)
• Tribunal canadien du commerce extérieur (TCCE)
• Tribunal de la concurrence (TC)

Adresse :
16750 TransCanada Highway
Kirkland, QC  H9H 4M7
Canada

Numéro de téléphone : 514-428-2638
Numéro de fax : 514-428-2662  

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