Published: April 2017Contents
i) What are the hot topics?
Worldwide, the most important issue relating to medical products is patient access. In developed countries, access is most often a question of reimbursement by national health programmes or insurers. As populations age and the cost of healthcare grows, reimbursers are increasingly seeking to impose price controls and rationing access to expensive medical products, including products that may offer significant benefits over existing therapies. In developing countries, the problem is lack of resources to provide the latest medical products to citizens, especially the poor.
ii) Tell us about any key legal developments – recent or pending – and their international impact.
Around the world, efforts to contain the costs of healthcare are leading to short-sighted measures that can, in the long run, significantly reduce incentives for discovery and development of new medical products. These include arbitrary and ill-considered price controls and other measures that undermine the incentives for innovation (such as compulsory licensing, weakened patent regimes and failure to afford innovators a reasonable period of regulatory exclusivity as a reward for risk-taking associated with research and development expenditures).
iii) What are the biggest opportunities and challenges for practitioners and clients?
Despite increasing pressures on pricing and reimbursement, manufacturers that introduce genuinely important new medical products may still be able to earn a reasonable return on their investments, provided that they fully understand the complex interaction of patent laws, regulatory exclusivity periods, and pricing and reimbursement systems in major markets. Legal experts play a major role in this process, advising on existing laws, monitoring changes in the law in major markets and, where appropriate, assisting in making the case for legislative or regulatory reform.
Covington & Burling LLP Beijing
Covington & Burling LLP New York