Pharmaceutical lobbyists are actively pushing for policies across several key areas in Europe and the UK, with their efforts often interconnected.

The main policy areas include patent protections, regulatory approval speed, and research subsidies, all of which are designed to support a favorable market for the industry.

While pricing is a major policy area, the industry's lobbying is often defensive, aiming to prevent governments from imposing stricter price controls.

1. Patent Protections

The most crucial policy area for pharmaceutical lobbying is the protection and expansion of intellectual property (IP) rights. The industry's entire business model is based on the idea that they need a period of market exclusivity to recoup the immense costs of research and development (R&D). Their lobbying efforts on patents focus on several key points:

• Opposing Patent Waivers: The industry vehemently opposed the temporary waiver of IP rights for COVID-19 vaccines and treatments at the World Trade Organization (WTO). Lobbyists argued that such a waiver would undermine the incentive to innovate and would not solve the core issue of manufacturing capacity in developing countries. Their successful campaign ensured that the UK and EU remained firm in their opposition, preserving their monopolies.

• Preventing "Evergreening" Crackdowns: Companies often seek to extend the life of a patent through a strategy known as "evergreening," where they secure new patents for minor modifications to an existing drug. Lobbyists work to ensure that regulatory bodies and patent offices do not adopt stricter rules that would prevent this practice, which allows them to maintain a monopoly and fend off cheaper generic competitors.

• Protecting Data Exclusivity: Beyond patents, pharmaceutical companies lobby for data exclusivity periods. This is a period during which generic drug manufacturers cannot use the originator company's clinical trial data to support their own marketing applications, even after the patent has expired. Lobbyists argue that this protection is essential for newer, more complex drugs and that it rewards the significant investment in generating the data.

2. Regulatory Approval Speed

Pharmaceutical lobbyists are continually pushing for policies that speed up the regulatory approval process for new medicines. They frame this as a patient-centric issue, arguing that faster approvals mean new, life-saving drugs get to patients more quickly.

• Lobbying for Expedited Pathways: The industry supports and lobbies for programs like the EU's PRIME (PRIority MEdicines) scheme and the UK's Early Access to Medicines Scheme. These programs are designed to fast-track the review of drugs that address unmet medical needs. Lobbyists work to ensure that these pathways are well-funded, efficient, and accessible to a wide range of products.

• Influencing Regulatory Harmonization: Pharmaceutical companies lobby for the harmonization of regulations across the EU to create a single, unified market. A fragmented regulatory landscape with different rules in each member state can slow down the approval process and increase costs. Their lobbying aims to reduce administrative burdens and streamline the process from development to market access.

3. Research Subsidies

Pharmaceutical companies seek subsidies and public funding for their R&D efforts. They argue that this is a public-private partnership that benefits society as a whole.

• Supporting Public-Private Partnerships: Lobbyists advocate for government grants, tax incentives, and other forms of public funding for research. They argue that this helps to reduce the financial risk of drug development and encourages the industry to focus on areas that are high-risk but have high societal value, such as treatments for rare diseases or antimicrobial resistance (AMR).

• Pushing for a "Transferable Exclusivity Voucher": A recent example of this lobbying is the push for a transferable data exclusivity voucher. Under this model, a company that develops a new antimicrobial drug (a notoriously difficult and unprofitable area of research) would receive a voucher that extends the data exclusivity period for another, more profitable drug in their portfolio. This measure is a direct result of lobbying to address the lack of R&D in AMR by providing a market-based incentive.

4. Pricing and Reimbursement

While the industry's lobbying on pricing is often reactive, it is arguably the most fiercely contested policy area.

• Fighting Against Price Controls: Pharmaceutical lobbyists work tirelessly to prevent governments from imposing strict price caps or to limit the power of national health systems to negotiate prices. They argue that aggressive price controls de-incentivize innovation and can lead companies to delay or even withdraw products from certain markets.

• Challenging Cost-Effectiveness Assessments: In the UK, a significant focus of lobbying is on challenging the decisions of the National Institute for Health and Care Excellence (NICE). Lobbyists argue that NICE's cost-effectiveness models do not fully capture the value of new medicines, particularly those with a high up-front cost but long-term benefits.

• Negotiating "Voluntary Schemes": The industry in the UK has engaged in intense lobbying to influence the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS). The scheme includes a revenue clawback, where companies pay back a percentage of their revenue on sales to the NHS. The industry consistently lobbies for lower payment rates, arguing that the current levels make the UK an uncompetitive market.