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Drug Security Act, 1734

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Drug Security Act
Long title An Act to establish and organize the National Drug Security Agency of Nouvelle Alexandrie, prescribe its duties and functions, and ensure the security and availability of essential drugs; among other purposes.
Introduced by Deputy Phuyu Nina Pillpe, FCP
Session of Cortes Federales 9th Cortes Federales
Extent Entire Federation of Nouvelle Alexandrie
Dates
Bill Status Introduced
Date introduced 1734 AN
Last updated 1734 AN


Background

The National Drug Security Agency was established to deal with the resolution of the 1734 New Alexandrian drug shortages. It was meant to streamline the development, stockpiling, and supply of essential drugs to ensure the future viability of the National Health Reserves, the strategic reserve of medical supplies, vaccines, and essential medical equipment.

Key Provisions

Legislative History

Status Date Tabled By Vote Outcome
Introduced in the Federal Assembly 1736 AN Deputy Sadrina Alessandros
Debated in the Federal Assembly
Passed in the Federal Assembly
Debated in the Chamber of Peers
Passed in the Chamber of Peers
Royal Assent

Bill as submitted to the "Hopper" of the Federal Assembly

NewAlexandriaCOA.png

A

BILL

TO

Establish and organize the National Drug Security Agency of Nouvelle Alexandrie, prescribe its duties and functions, and ensure the security and availability of essential drugs; among other purposes.

DRUG SECURITY ACT, 1736

Ordered, by the Federal Assembly of Nouvelle Alexandrie,
to be Printed, 1736 AN.

_______________________________

BE IT ENACTED by the King’s Most Excellent Majesty, by and with the advice and consent of the Federal Assembly, in this present session assembled, and by the authority of the same, as follows:-

PART I
GENERAL PROVISIONS.

Article 1: Short Title.

  1. This act shall be known as the Drug Security Act, 1736.

Article 2: Definitions.

  1. "Agency" means the National Drug Security Agency of Nouvelle Alexandrie.
  2. "Drug Security" means the availability of safe, effective, and affordable drugs and medicines in sufficient quantities to meet the health needs of the population.
  3. "Essential Drug" means a drug that has been identified by the Department of Social Security and National Solidarity as having an essential role in the treatment of priority health conditions.
  4. "Drug Supply Chain" means the system of individuals, organizations, activities, technologies, and resources involved in the creation and delivery of a drug or medicine to a patient.
  5. “Director-General” refers to the head of the National Drug Security Agency, responsible for overseeing the agency’s operations.

PART II
NATIONAL DRUG SECURITY AGENCY

Article 3: Creation, Powers and Duties of the NDSA

  1. The National Drug Security Agency is hereby established as an autonomous agency under the supervision of the Department of Social Security and National Solidarity, tasked with ensuring drug security in Nouvelle Alexandrie.
  2. The Agency shall be headed by a Director-General, who shall be appointed in accordance with procedures outlined in this Act and shall report directly to the Minister of Health.
  3. The Agency shall have the authority to establish necessary departments, divisions, and offices to carry out its functions.

Article 4: Duties and Functions

  1. The Agency is responsible for the following:
    1. Developing and implementing a national drug security plan to ensure the continuous availability of essential drugs.
    2. Monitoring the supply chain of essential drugs, identifying potential disruptions, and developing mitigation strategies.
    3. Maintaining a strategic stockpile of essential drugs to address shortages and emergencies.
    4. Promoting domestic production of essential drugs and supporting research and development in this area.
    5. Collaborating with international organizations and other countries to secure access to essential drugs.
    6. Developing and implementing emergency response plans for drug shortages.
    7. Collecting and analyzing data on drug consumption, prices, and availability.
    8. Promoting rational drug use and medication adherence.
    9. Enforcing drug quality standards and regulations.
    10. Cooperating with other government agencies and stakeholders to achieve drug security objectives.
  2. To carry out its functions, the Agency shall have the power to:
    1. Conduct inspections of drug manufacturing, distribution, and retail facilities.
    2. Issue licenses and permits for drug manufacturing, importation, and distribution.
    3. Impose sanctions for violations of drug regulations.
    4. Collect data and information from relevant stakeholders.
    5. Enter into contracts and agreements with private entities.
    6. Acquire and dispose of property.
  3. The Agency shall develop and maintain an essential drug list based on evidence-based criteria and public health needs.
    1. The essential drug list shall be regularly reviewed and updated to reflect changes in disease burden and therapeutic options.
    2. The Agency shall promote the rational use of essential drugs through education and awareness campaigns.
  4. The Agency shall monitor drug prices and work to ensure that essential drugs are affordable to the population.
    1. The Agency may implement price controls or other measures to regulate drug prices.
    2. The Agency shall promote generic drug use and biosimilars to increase affordability.
    3. The Agency shall explore innovative financing mechanisms to improve access to essential drugs.
  5. The Agency shall enforce strict quality standards for drugs throughout the supply chain.
    1. The Agency shall conduct regular drug inspections and quality testing.
    2. The Agency shall establish a drug vigilance system to monitor adverse drug reactions.
    3. The Agency shall promote the safe and effective use of drugs through education and training.
  6. The Agency shall work to ensure equitable access to essential drugs for all segments of the population.
    1. The Agency shall address barriers to access, such as geographical disparities, poverty, and lack of healthcare infrastructure.
    2. The Agency shall collaborate with other government agencies and stakeholders to improve drug distribution and delivery systems.


Article 5: Director-General

  1. The Director-General shall be appointed by the President with the approval of the Cortes Federales. The Director-General shall have a term of five years and may be reappointed once.
  2. The Director-General shall possess expertise in public health, pharmacology, or a related field.

PART III.
'CLOSING PROVISIONS.

Article 6: Appropriations.

  1. The amounts necessary for the implementation of this Act are hereby appropriated from available funds not otherwise appropriated.

Article 7: Enforcement.

  1. The Agency shall submit an annual report to the Cortes Federales and the DSSNS on its activities, achievements, and challenges.

Article 8: Closing Provisions.

  1. This act shall apply to all of the Federation of Nouvelle Alexandrie.
  2. This act shall not become law unless it has been given Royal Assent.
  3. This act shall be published and made publicly available.
  4. This act shall take effect on its approval.
  5. If any provision of this act, or the application thereof to any person or circumstance, is held invalid, the remainder of the act, and the application of such provision to other persons or circumstances, shall not be affected thereby.
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