One of the main reasons for non-compliance with pharmacovigilance is the inadequacy of the SDEA. Routine monitoring of data exchanged according to the SDEA is required. There should be a database for SDEAs for all products, partners, dates of agreements, drugs covered, bonds and documents exchanged, etc. One of the most recent major trends in the pharmaceutical world is the joint development and commercialization of drugs. This includes all possible agreements with other companies, both domestically and abroad. We can now see several companies that market the same drug in the U.S. and other companies that market the drug overseas. Clinical trials can be conducted jointly or outsourced to CROs or other partner pharmaceutical companies. This model can be a challenge for the third-party supplier, unless the generic drug manufacturer has a number of key executives who can understand the criticalness of safety obligations and facilitate and support decisions so that the supplier can act to comply.
There is also a risk that the company will not be ready to bring everything home on the agreed date. The main players in setting up SDEAs are lawyers. All contracts are (or should) be approved by the legal division. In small businesses, these problems are generally not a problem because employees all know each other and work well together. In large companies with lawyers sitting in offices on two or more continents and with many lawyers dealing with different issues, it can be difficult to identify the person who deals with drug safety issues. In many companies, the legal department knows all the partners involved in the marketing of companies` products. In large companies that sell hundreds of drugs in more than a hundred countries, there can be tens of thousands of such contracts! This was certainly the case in one of the large companies where I worked for many years. We have had more than 10,000 contracts in approximately 110 countries around the world. Maybe there`s a database with them. You can live in several places around the world and many are not in English.
In my experience, legal services are happy to help with drug safety with ADES, but they often know nothing about all the contracts that exist in the world. Sometimes the financial department is better informed of all agreements around the world, because they have to send and receive money! The FDA and EMEA (which put medical safety at the forefront of EU legislation when the new pharmacovigilance (PV) legislation was published in July 2012) are legally responsible for PV by large innovative pharmaceutical companies under such licensing/outsourcing agreements. SDEAs are written contracts drawn up between two or more cooperations to define the responsibilities of each party by referring to each pharmacovigilance activity.