Have any new laws, regulations or judicial decisions impacted your company’s business or your legal practice?

There are many legal developments which have an impact on my company’s business, however one critically key area which has been an opportunity for the legal department to add value and navigate is market access. Market access is how pharmaceutical manufacturers get the right drug to the right person at the right price, with someone (a government, or an insurance company) paying for it. Favourable pricing and reimbursement conditions for pharmaceutical products are critical to their commercial success for patients to have access to life saving medicines. The laws, rules and processes for the evaluation of medicines and their value to healthcare systems are different in each country.

Pricing and reimbursement terms are negotiated country by country but are linked globally by international reference pricing and principles of health equity which drive convergence of public list prices of drugs across different countries. Legal teams, such as my team at Alexion, are becoming expert at navigating constantly changing local country laws on pricing and reimbursement and crafting contractual solutions to enable the broadest access to medicines for those who need them. This involves innovative contracting and risk sharing including pay for performance, rebates, free drug programs and the list goes on.

This year, the European Commission is expected to propose new pharmaceutical legislation pursuant to its “Pharmaceutical Strategy for Europe.” It is possible that it will restrict the scope and duration of IP and regulatory rights such as regulatory data protection, rewards, and incentives for pediatric and orphan medicinal products, and patent term restoration rules, especially where companies do not disclose R&D costs or do not launch their products in most or all EU member states.

The European Commission is also rolling out its HTA Regulation (2021/2282), which provides for mandatory joint clinical health technology assessment of new centrally authorised drugs and selected medical devices as of 2025. In the meantime, the commission will continue to support HTA cooperation between member states.

These new rules coupled with the ongoing budget pressures caused by the pandemic, will accelerate the push by the EU and individual member states to drive down drug prices. This will also impact Switzerland, and life sciences or biopharma companies running their European or international businesses from Swiss hubs. There is a push for drug pricing to be more ‘value-based’ or ‘cost-based’ R&D expenditure-focused and either of these approaches will impact Switzerland and beyond.