Policy and Process Development Guidance

Early Access Care offers corporate Policy and Process consultancy services to help you navigate the labyrinth of regulatory compliance requirements, making it streamlined and simple.

Early Access Care has advised corporate clients globally headquartered in Europe, The United States, and Asia.

Country regulations drive corporate policy to a large extent, and in turn, industry best practice has resulted in the following principles for most corporate policies:

  • The patient must have a serious or immediately life-threatening condition.
  • The patient must have exhausted all other treatment options, including alternative approved medicines or clinical trials that are available.
  • There is sufficient evidence to demonstrate a favorable benefit-risk ratio.
  • Providing access will not jeopardize existing clinical trials or potential regulatory approval of the investigational medicine.
  • There is an adequate supply of the medicine for all ongoing clinical trials, as well as individual access requests.
  • Access is compliant with local laws and regulations in the patient’s country of residence.

Corporate policies also provide transparency to the process of making a request, how many days to expect for the procedure, and in many cases the pharmaceutical company website has specific eligibility criteria. A transparent, clear policy and process is integral to managing expectations with early access programs.

Our leadership has provided expertise and policy development guidance to the Brookings Institute for Health Policy, FDA, and small and large biopharmaceutical companies.

In addition to policies and processes, EAC provides Playbook development services providing a comprehensive step by step guide for all pharmaceutical stakeholders. Our consultative group can develop programs from the simplest to comprehensive playbooks. Contact us for your program.

We have been sharing our expertise with small, mid, and large sized pharmaceutical and biopharmaceutical companies for many years through symposia and publications. Our leadership contributed to the Brooking’s Health Policy Issue Brief “The Four A’s of Expanding Patient Access to Life-Saving Treatments and the Regulatory Implications”. This reference provides a key source of information of considerations in the establishment of a pre-approval policy relevant to any sized biopharmaceutical company.

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