Below: Regulatory affairs expert Dr Danielle van Dalen and PA Chairman Prof. Mark Eyskens
A rapidly increasing number of European, US and Asian industries has appointed PA to secure the fastest and most correct trajectory to regulatory authorization of new (advanced technology) products. PA strategizes, drafts texts, communicates with all relevant authorities, and ensures market access throughout the EU, the US and Asia. A specialist team is led by a former top industrial regulatory expert and scientist.
Microbial Plant Protection Products
Despite the consequences for food production of the war in Ukraine the European Union confirmed the implementation of its Green Deal and Farm to Fork strategies. This includes the reduction of chemical pesticides use. According to the European Commission this requires a transition from chemical to low-risk alternative and particularly microbial plant protection products (MPPPs). According to the website of DG SANTE the latter are “inherently safer than chemicals”. In an effort to overcome substantial controversies, the European Parliament, with the support of the Microbial Plant Protection Products Task Force, may come to the urgently required (interim) fast-track solution. PA helped establish and operate this industrial platform.
Biotech Solutions for Food Production
PA helped establish industrial platforms and groups holistically integrating the required variety of interests enabling the first-ever use of genetic modification in food production (chymosin instead of a calf’s rennet in cheese production); the first-ever transgenic animal (Bull Herman with genetic information from a female breast); new ingredients in infant formula; new additives in both food and feed. Intensive cooperation with the UK Vegetarian Society and several patients’ and consumers’ associations helped chart the way forward.
As the world population grows to 9 billion people, current ways to produce food and feed must change to prevent disastrous global food shortages. The African population will double while its food producing capacity will sharply reduce. The result may be a massive migration that among others the new European Union Global Gateway 300 bn Euro fund seeks to prevent. PA works through multi-stakeholder groups to use tech-based opportunities.
Ports and Infrastructure
In Europe (Milford Haven, LNG terminal), the Middle East (Port of Sohar) and Asia (Kuala Tanjung) PA helped create the required alliances and promote key investments (Sohar Aluminium). This included permits, adaptations of laws and regulations, and approaches to port management.
A group of major European energy and infrastructure enterprises tasked PA to secure European funding for multibillion Euro projects outside the European Union. First Ecofin and next the European Council took the required decisions in 2014. In 2021 the European Commission announced the establishment of the European Union 300 bn Euro Global Gateway fund. PA currently advises industries and countries on the potential use of these funds.
Cybersecurity and International Trade
The combination of EU sanctions on Russia, deepening tensions between the US and China, and growing threats against both state and industry targets through cyberspace raises question marks regarding the content and volume of trade and investment of the Western Allies with and in Russia and China. Discussions gain shape on and through new multi-stakeholder platforms. The goal is to help establish a balance between security, international trade and economic stability concerns.
Prof. Dr Ruud Schotting of Utrecht University’s Sultan Qaboos Academic Chair for Quantitative Water Management presented the potential of the further development of the so-called bio-sealing technology creating subsurface manmade aquifers in China, Indonesia, EU Brussels and most recently at Algarve University in Portugal. A generous donation by the Government of the late Sultan Qaboos of the Sultanate of Oman may soon lead to the first major test projects. These will save precipitation where this is rare. The future of agriculture and drink water capacity may depend on such technologies in drought-stricken regions. PA helped establish this Academic Chair and promotes the use of this technology globally.
Antimicrobial Resistance (AMR)
The global overproduction and overuse of cheap antibiotics for purposes of animal growth and disease prevention contribute to Antimicrobial (bacterial) Resistance (AMR). Today, AMR kills more than malaria and HIV combined. According to Lord Jim O’Neill (formerly Commercial Secretary to the Treasury and former Chief Economist of Goldman Sachs) this may lead to 300 million AMR deaths by 2050. At one of the many AMR actions of PA Lord Jim referred to a so-called market failure: the overproduction of antibiotics makes the sales price so low that industries cannot invest in new antibiotics, while the current ones lose all efficacy. UN IACG and the European Commission have tried to establish rules limiting antibiotics use without much success. The World Bank estimates a further growth of antibiotics use with 67%. New and improved regulatory frameworks and enforcement are the only way to assist industries and the farming community to step away from a potential AMR outbreak. www.stopAMR.eu
While regulations are slowly developed to protect privacy, no effective regulations are in place to protect inadequately educated and trained information consumers against an onslaught of fake and misleading information through the internet. Populations with a history of combating the worst kinds of Colonialism appear successfully subjected to gross distortions of for instance European and American history. A wise, balanced, transparent, structured and institutionalized action is required to assist both educational institutions and publishers, editors and journalists in former colonies to both repair educational gaps and correct fake and distorted news. As a holistically integrated, multicultural, multidisciplinary and multi-religious group the PA International Foundation and PA companies have started to formulate plans and projects honoring the difference and celebrating diversity. While this has to be the future of mankind, acting today seems to be a conditio sine qua non.