Innovative And Generic & Biosimilar Pharmaceutical Industries Unite On Commitment To Equitable Access To COVID-19 Medicines And Vaccines, While Flagging Where Further Help Is Needed From Others

On the occasion of the World Health Assembly, the world’s research-based and generic & biosimilar pharmaceutical industry bodies delivered a statement declaring their shared commitment to equitable access to COVID-19 medicines and vaccines. In their joint statement, the two global pharmaceutical industry bodies acknowledge their responsibility and commitment to support the international response to the pandemic with their unique scientific, technical and manufacturing expertise to meet the increased demand for medicines; and to the discovery and development of affordable therapeutics and vaccines for COVID-19. However, for the pharmaceutical industry to do so fully, it requires others to play their part.

The two pharmaceutical industry bodies list eight areas of shared concern that require international solidarity, cooperation, coordination and support. The areas covered involve trade, disease surveillance and demand forecasting, regulatory alignment, partnership, support for balanced intellectual property; and for multilateral organizations and country leaders to align on allocation principles to ensure fair and equitable access to COVID-19 treatments and vaccines. They also underscore the need to ensure adequate resources are spent to build stronger, more resilient health systems.

From the outset of the coronavirus pandemic, the whole pharmaceutical industry has shown commitment to business integrity and stepped up to bring its expertise to meet the increased demand for medicines; and to the discovery and development of affordable therapeutics and vaccines for COVID-19. The two global trade federations representing the research-based pharmaceutical industry (IFPMA) and the generic and biosimilar medicines industries (IGBA), are founding partners of the Access to COVID-19 Tools (ACT) Accelerator. By joining this unique multi-stakeholder partnership, the industry bodies recognised their shared responsibility in bringing their unique scientific, technical and manufacturing expertise to meet the increased demand for medicines. In the spirit of the principles of international solidarity, the two pharmaceutical bodies call on others to play their part in providing the enabling environment needed for the industry to do its job in the best way possible.

Moving forward, the two industry bodies (IGBA and IFPMA) point to the importance of ensuring adequate resources are spent to build stronger, more resilient health systems that can cope with complex health challenges. It will also be essential to minimise the disruption to the provision of essential health services and continue the fight against priority diseases. Not to do so will undermine the significant progress we have made together on major health challenges such as non-communicable diseases (NCDs), routine immunisation, and other infectious diseases.

Eight innovative and generic & biosimilar pharmaceutical industries shared enabling environment considerations:

1. Ensure trade barriers, including export restrictions, are lifted, as they impact the ability to receive materials, including critical raw ingredients, active pharmaceutical ingredients (APIs) and medical devices for our own supply chains, and impede the ability to distribute critically-needed finished products;
2. Ensure continued disease surveillance and open and rapid sharing of information;
3. Facilitate rapid development of robust forecasting models and clear, coordinated demand planning to inform decisions on clinical development, scale-up, and right-sizing of manufacturing assets for diagnostics, therapeutics and vaccines;
4. Establish, in collaboration with cross-sector initiatives such as ACT-A, risk-sharing models, including funding for manufacturing investments and advance purchase agreements, that recognize the uncertainty of the pandemic as the actual demand, geography, and epidemiology of the disease evolves over time;
5. Encourage national regulatory agency alignment and collaboration across borders through good reliance practices that improve and expedite access to therapeutics and vaccines, whilst ensuring product quality, efficacy and safety and international manufacturing standards;
6. Create opportunities for partnership between the private and public sectors across the spectrum of health issues that are critical to address the pandemic.
7. Support an effective and balanced intellectual property framework, a key factor to enable R&D, accelerate manufacturing scale-up, and facilitate licensing for therapeutics and vaccines;
8. Ensure equitable access for COVID-19 therapeutics and vaccines at global and national levels by supporting multilateral organizations and country leaders to align on allocation principles in line with WHO agreed principles.

About IGBA
The International Generic and Biosimilar medicines Association (IGBA) was founded to strengthen cooperation between associations representing manufacturers of generic and biosimilar medicines from around the world. The IGBA is at the forefront of preserving sustainable competition within our industry, by stimulating competitiveness and innovation in the pharmaceutical sector; thereby ensuring millions of patients worldwide have access to high quality, pro-competitive medicines. For more information, visit www.igbamedicines.org.

About IFPMA
IFPMA represents research-based pharmaceutical companies and associations across the globe. The research-based pharmaceutical industry’s 2 million employees research, develop and provide medicines and vaccines that improve the life of patients worldwide. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health.