WIT Pharma

GR & Regulatory Environment

We help clients understand the logic of the regulator and the payer before a decision is made: the national procurement regime, the 'second-wheel' rule, localisation and reimbursement.

Who it's for

  • Companies whose strategy depends on public procurement and the national regime (Decree No. 1875)
  • Manufacturers weighing localisation (SPIC, the SSM list) and preferences
  • Portfolios sensitive to changes in pricing and the lists

What you get

Initiative monitoring

Analysis of government and regulator initiatives with an assessment of their impact on the client.

National regime assessment

Impact of the 'second-wheel' rule and the SSM list on company strategy.

Production localisation

Support of SPIC, full-cycle production and confirmation on the Ministry of Industry portal.

Regional analytics

Budgets and reimbursement practice across Russian regions.

Procurement models

Innovative contracting and risk-sharing agreements.


How we work

  1. 01

    Regulatory audit

    2-3 weeks

    Assessing the portfolio's exposure to regulatory and procurement factors.

  2. 02

    Scenario analysis

    2-4 weeks

    Modelling the impact of initiatives and the national regime on the portfolio.

  3. 03

    Recommendations & plan

    2 weeks

    Prioritizing measures - localisation, pricing and access to the lists.

  4. 04

    Ongoing monitoring

    by subscription

    Regular briefings on changes and on regions' preparation for procurement.


Project example

International pharma · oncology & cardiology

Objective. Assessing the impact of the 'second-wheel' rule and preferences for domestic manufacturers on the client's portfolio.

What we did. Analysed regulatory scenarios, assessed innovative contracting and therapy-financing models, and prepared recommendations.

Outcome. The client adapted its procurement strategy ahead of the change in the national regime.

Let's discuss your case

We'll propose the best format and timeline for your product.

Discuss a project