Impact Of International Trade Regulations
By Ana Santibañez and Daniela Martinez
The significant number of national and international trade regulations are challenging for the development of logistics strategies for global clinical research. Identifying the similarities, differences and obstacles pharmaceutical companies face while importing and exporting medicinal products for clinical trials creates an opportunity to streamline the process, remove barriers, and improve efficiency.
Alongside global pharmaceutical market growth in the last decade, there have been continual developments in health regulations for different regions. For international logistics strategy design, this has become a key influence on competitiveness, as the industry has to try to foresee and react to evolving approaches for regulatory compliance and risk reduction in each country. To look at the variation in regulations across the globe, we consider four major regions: Asia, Europe, Latin America, and North America.
For a long time, the pharmaceutical operations in the European Union (EU) were rather bureaucratic, which did not help to encourage clinical trial development in the region. Import and export operations of pharmaceuticals to EU countries were a big challenge, which pushed countries to find a way to supply domestically. Then, in 2014, the most recent EU Clinical Trials Regulation (No 536/2014) was implemented, with the purpose of streamlining health authorizations and harmonizing requirements without having to implement individual national legislation. This has greatly simplified and increased the efficiency to participate in the market and run clinical trials in the EU by allowing the international distribution of source materials and final products with lower costs and in shorter periods of time.
Asia is an attractive market for clinical research with 54 percent of the world’s population growth from 2010 to 2015. As an emerging market for pharmaceutical companies, Asia presents various advantages in countries such as India and China, which, with their large populations and genetic diversity, offer the opportunity of global studies at a lower cost.
As the pharmaceutical market expands in the region, challenges may be encountered at a regional or country level. Take India, for example. There are local and global regulatory mechanisms, as well as laws and guidelines, to which companies must comply. Additionally, local regulations in China do not allow first-in-man dosing studies to be conducted if the drug was developed in another country. Asian regulations related to the International Air Transport Association (IATA) also present challenges that have forced different parties, such as couriers, to adjust and specialize in the pharmaceutical logistics industry.
Latin America (LATAM) has always been an attractive region for development due to the cultural tendency of progress and their emergent economies. However, this region is constantly facing changing regulations that can complicate distribution. According to the Centre for Innovation in Regulatory Science (CIRS), which has held workshops on analyzing regulatory practices of emerging markets, the need for regulatory alignment has been identified. Given the fact that each country manages different levels of regulatory sophistication, focus is on the regulatory approval process and timelines.
The majority of LATAM countries have aligned their local regulations with the Declaration of Helsinki, the Council for International Organizations of Medical Sciences, and ICH GCP guidelines.
North America's trend in pharmaceutical matters has always been focused on getting a balance between safety, control and marketing support. The U.S. FDA is working to finalize and implement several proposals to help improve clinical trial development, although it is yet unknown how these may impact the import and export process for clinical trial purposes in the country.
When embarking on global studies, the pharmaceutical industry needs to understand each country’s healthcare, medical research and international trade policies. They also need to pay attention to non-governmental organizations (NGOs), such as the World Trade Organization (WTO), World Customs Organization (WCO), International Chamber of Commerce (ICC) and World Health Organization (WHO), which support global industry development by unifying regulations for the signing countries.
In conclusion, it is crucial for the pharmaceutical industry to follow the latest regulatory updates of applicable laws and guidelines, maintain the highest standards of quality and safety in the development of new treatments, and ensure their ability to efficiently import and export clinical trial supplies while remaining compliant with international and domestic regulations.
Bios:
Ana Santibañez:
Ana is a Trade Compliance Leader in PAREXEL’s Global Trade Compliance team, based in Latin America. She has 6 years of experience in international and commercial affairs for pharmaceutical and clinical investigation, and a degree in Foreign and International Trade.
Daniela Martinez:
Daniela is a Trade Compliance Leader in PAREXEL’s Global Trade Compliance team, based in Latin America. She has 7 years of experience in international trade, commerce affairs and clinical investigation; and Bachelor’s and Master’s degrees in International Business/Foreign Trade.