National and market related policy issues

National and market related policy issues

Respond to the policy challenges affecting market access

Policy makers are increasingly seeking to deliver maximum public health benefits from finite public resources and establish a more legitimate, transparent and accountable basis for health care priority-setting and decision-making. As a result, the life sciences industry is under pressure to demonstrate value and absorb an ever greater level of risk to satisfy the expectations of payers and policy makers at national, regional and local levels.

Companies and policy makers need to understand the changing policy environment and the way this affects business decisions. There is increasing convergence in policies across countries and regions, with significant consequences for the industry. CRA's Life Sciences Practice helps clients to anticipate trends and compile the evidence needed to respond to policy challenges affecting market access. We develop analyses and economic assessment that influence policy debates around the world, from shaping the patent regime in Europe to understanding barriers in access to medicines in developing countries.


Health Technology Assessment

  • Insights into the needs and workings of HTA agencies around clinical, economic, social and ethical issues
  • Anticipating HTA policy developments
  • Helping companies engage in the HTA process and shape its evolution

Innovative contracting options

  • Analysis of innovative pricing mechanisms instigated by Payers, such as Risk Sharing Schemes, managed entry agreements (MEA) and outcome based agreements
  • Support in understanding the evolution of MEA and developing evidence to back up contracting strategies

Rare diseases and orphan drugs policies

  • Analysis and insights into the policy environment for funding and access to medicines for rare diseases
  • Evidence based perspectives on future pricing trends for orphan drugs
  • Testing the sustainability of orphan medicines business models in terms of ROI and costs incurred to develop and bring new therapies to the market

Competitive tendering for pharmaceuticals

  • Analysis and comparison of procurement and tendering protocols across international markets
  • Assessment of best practice and use of bidding to secure sustainability while leveraging healthy competition

Pricing policies

  • Advice on pricing mechanisms such as Value Based Pricing and Risk Sharing and their impact on companies’ strategies
  • Implications of international reference pricing and differential pricing between Europe and developing countries
  • Assessing trends in indication based pricing where a drug is used in different indications
  • Analysis of the implications of joint procurement

R&D policies and the innovation value chain

  • Assessment of national policies around pharmaceutical innovation
  • Investigation of barriers to growth of pharmaceutical companies
  • Research into market failures associated with R&D funding issues

Recent engagements

  • Comparative analysis of the role and impact of Health Technology Assessment
  • Review of the experience from EUnetHTA pilots
  • Development of a template for using Managed Entry Agreements
  • Assessment of the value of MEAs in increasing access in middle-income countries
  • Identifying payer perceptions concerning the orphan medicinal product sector
  • Support for EFPIA on the use of bidding to purchase pharmaceuticals in China
  • Tender management strategy, covering how to influence tender design, relationship management, responding to tenders and monitoring
  • Workshops on tender management, facilitating best practice across affiliates
  • Interactions between HTA and external reference pricing
  • Investigation of the consequences of indication based pricing
  • Assessing the value of healthcare biotech to Europe and implications for the policy environment
  • Investigation of innovation in middle-income countries
  • Identifying barriers to growth and funding challenges in R&D


Tim Wilsdon
Vice President