Terms of Reference: ACSS Consortium

Australia, Canada, Singapore, Switzerland Consortium

12 September 2017

1 Context

The global community is being challenged with new viruses and diseases as a result of the complex interrelationship between social, economic and environmental factors. Transborder environmental and health threats, the rapid increase in new biotechnology and nanotechnology products (and combinations thereof); regulatory systems incapacity to consider a given product through its entire life cycle, all raise serious regulatory, ethical, social, environmental and economic issues.

The globalization of the pharmaceutical/health product market and the fact most of the Western nations import the majority of their products raises important capacity issues associated with current regulatory systems. As countries strive to address these challenges, many face similar resource, scientific and regulatory gaps that offer tangible opportunities for collaboration.

Against this backdrop, a virtual international work-sharing consortium has the potential to be a driving force behind domestic efforts to bring about tangible improvements in health product safety, and quality and efficacy of regulatory frameworks. Reduction in regulatory burden for both the regulator and industry, along with and better quality, safer health products as a result of regulatory cooperation could yield a range of interrelated benefits – improved human health resulting in lower health care costs and higher (e.g., employee) productivity which then translates into gains in economic growth and social stability.

Why virtual as opposed to geographically-based operations? The very nature of work-sharing implies fluidity and seizing opportunities as they arise, yet is grounded by the terms agreed to under the work-sharing arrangement. If a long-term perspective is taken, synergies will be created, leveraging for resources explored, and an increase in monetary, regulatory and ultimately public health benefits expected to significantly outweigh the costs.

With globalization; the rapid emergence of new technologies; increasing resource needs; and regulatory gaps both domestically and internationally, work-sharing and reliance are means to improve the current modus operandi and foster greater global regulatory synergy as well as convergence and harmonization. The intent is to improve the efficiency and effectiveness of domestic regulatory systems in an effort to safeguard and enhance the health of communities around the world.

2 Purpose

The ACSS Consortium is a cooperation of like-minded medium-sized regulatory authorities. The participating authorities face very similar challenges, such as increasing workload, increasing complexity and at the same time increasing pressure on the available resources.

The purpose of the international work-sharing consortium is to build synergies and result in improved health and safety benefits as a consequence of enhanced effectiveness and efficiency of domestic regulatory systems and the interface between each. It constitutes a multilateral forum to facilitate and promote interaction using respective bilateral and multilateral agreements as the foundation for which to identify and implement work-sharing initiatives.

The consortium capitalizes on each country's area of strength, addresses gaps in science, knowledge, and expertise and leverages resources to help expedite risk assessment processes while maintaining or raising quality and safety standards. The consortium builds on existing international networks, initiatives and mechanisms to advance work and information sharing along health product lifecycles.

The consortium can also serve as a "testing ground" for new and innovative collaborative approaches and can serve as a pilot group for larger international initiatives (as it currently does e.g. for the International Generic Drugs Regulators Programme, IGDRP).

3 What we mean by "Work-sharing"

Work-sharing under the ACSS Consortium is defined as:

Making use of work products and leveraging resources and expertise of as well as sharing workload between agencies while retaining the sovereignty to take independent decisions and maintaining high quality and safety standards.

This includes:

  • Reliance1: the act whereby the regulatory authority in one jurisdiction may take into account and give significant weight to – i.e., totally or partially rely upon – evaluations performed by another regulatory authority or trusted institution in reaching its own decision. The relying authority remains responsible and accountable for decisions taken, even when it relies on the decisions and information of others.
  • Work-sharing1: a process by which regulatory authorities of a number of jurisdictions share activities. Work-sharing entails exchange of information consistent with the provisions of existing agreements and compliant with each agency's or institution's legislative framework for sharing such information with other regulatory authorities. Other opportunities for work-sharing include: jointly assessing applications for marketing authorizations or therapeutic product manufacturing sites, joint work in the post-marketing surveillance of therapeutic product safety, joint development of technical guidelines or regulatory standards, and collaboration on information technology.

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  1. Definitions are taken from the WHO draft GRP Guideline (pdf,1.27Mb)*

4 Objectives

The objectives of the ACSS Consortium are:

  • To provide an effective and efficient alternative to participating regulators working independently on similar scientific and regulatory work.
  • To enable participating regulators to draw on the very best scientific and technical data, information, expertise and resources from around the world to better inform regulatory decisions including risk assessments, along the product lifecycle.
  • To improve each participant's effectiveness and efficiency as a regulator by providing a framework for identifying work-sharing opportunities, facilitating action and achieving tangible results.
  • To provide participating regulators with a mechanism to share with other regulatory authorities their unique knowledge in specific scientific areas, i.e., compliance and enforcement and post-market surveillance, as well as best practices thereby making a significant contribution to addressing global health and safety issues.
  • To create or complement existing communication networks and an increased dialogue and understanding of the basis of scientific advice between regulators and decision makers throughout the lifecycle of products.
  • To explore new initiatives and concepts.

5 Principles and key success factors

Agreed upon principles guide the consortium's deliberations such as respect, transparency, openness, flexibility, equality, and resource equity. The concept of an international work-sharing consortium is based on the premise that each country has something to offer the other members. All ACSS Consortium members have equal status in terms of engagement and decision-making and may "opt-out" from any work plan activities. This could, for example, occur due to constraints presented by existing regulatory systems or because the specific project addresses the concerns of only a subset of members.

Information shared within the Consortium should be considered as non-public information and handled in confidence by all members, unless this is otherwise indicated. Details are provided in the respective bilateral / multilateral arrangements.

Confidential documents and information is shared amongst all members through a secure information sharing platform (e.g. SharePoint).

A key success factor is to ensure that no duplication exists with other international tools and mechanisms.

6 Membership

The members of the ACSS Consortium are:

  • The Therapeutic Goods Administration of Australia
  • The Health Products and Food Branch at Health Canada, Canada
  • The Health Sciences Authority of Singapore
  • Swissmedic, Swiss Agency for Therapeutic Products, Switzerland

7 Governance

The ACSS Consortium is steered and directed by the heads of the participating regulatory authorities. The Heads of Agencies (HoA) act as the Steering Committee and meet at least two times a year, preferably face-to face. For practical reasons, these meetings take place in conjunction with other meetings such as the DIA Annual Meeting or the Summit of Heads of Medicines Regulatory Agencies & ICMRA Meeting. In addition to face-to-face meetings the HoA have periodic and ad hoc web/teleconferences.

The HoA

  • review the progress of the ongoing work and projects
  • make decisions on behalf of the Consortium;
  • define the strategic direction;
  • identify and prioritises challenges to be addressed and collaborative activities;
  • authorise resources in support of advancing the ACSS Consortium's goals and objectives.

All parties are committed to the goals and objectives of the ACSS Consortium and to making best efforts to reach consensus.

For the management of the ongoing business, each agency nominates a Coordinator.

This person

  • acts as the primary contact,
  • is responsible for the preparation and organisation of meetings of the Heads of Agencies
  • ensures effective communication between the members and
  • coordinates the work of the experts in the ACSS Consortium Working Groups (WGs).

8 Scope of Activities

The products covered are medicinal products for human use and medical devices. Sample discussion topics might include scientific and technical requirements related to efficacy, safety or quality for drug marketing (registration), regulatory oversight of clinical trials and manufacturing sites, electronic data strategies; and other issues of emerging concern.

9 Collaboration Mechanisms

A. Working Groups

The HoA may establish new working groups to undertake certain work on identified/selected topics or projects, chaired by a member. These working groups shall have clearly documented mandates and specific activities. Participation in the groups is open to all members and is voluntary. The WGs are chaired by one of the ACSS Consortium members; wherever possible the burden to chair WGs should be equally distributed amongst the members. Assigning the WG chairs and defining their term is left to the consensus of the WG members. The coordinators are informed about changes in the rapporteurship.

Chairs of the groups are expected to keep the HoA updated on a periodic basis, or upon request. The work plans of the WGs are updated annually; the mandate when necessary (e.g. in case of a change of scope/goals of the WG).

The Chairs of the WGs are also responsible for keeping the contact information of their group members up-to-date.

WGs meet regularly via telephone conference in order to progress the work as outlined in the work plan. Face-to-face meetings are encouraged when deemed necessary, and should take place in conjunction with conferences or meetings or other initiatives. Face-to-face meetings have to be approved by the HoA in the context of the approval of the work plan.

B. Project Proposals

All members may propose, in writing, projects and work items to the HoA for consideration. These recommendations can come through formal submissions or through presentation at a meeting of the HoA. As a basis decision-making, a mandate and initial work plan for the group have to be prepared and proposed to the HoA. Decision-making on new project proposals at the HoA should aim at consensus wherever possible.

C. Networks

For the ongoing exchange and sharing of information, the ACSS Consortium may establish networks. These networks may be formed by key focal points from each of the members.

10 Communications

A Public Statement

Following a HoA face-to-face meeting a public statement is issued at least once per year to communicate major achievements and decisions. This statement is published on each member's website.

B Requests by media / requests for publication

Requests by media or requests for publication about the ACSS Consortium activities should be sent to all Coordinators for alignment. Depending on the importance and urgency, the matter is referred to the HoA for decision making by e-mail or at their next meeting (telephone conference or face-to-face).

C Presentations

Presentations at international meetings or fora about activities of the ACSS Consortium should be aligned with the Coordinators prior to the event.

D Language

The working language within the ACSS Consortium is English. Meetings will be conducted in English and documents will be distributed in English. It is each member's responsibility to translate any documents into additional languages as needed.

11 Support of activities

Members are responsible for their own travel and accommodation cost.

12 Review of Terms of Reference

The Terms of Reference will be reviewed and approved annually by the HoA or when necessary.