Contracting in large-scale Pharma - regulation, compliance and contract management in the pharmaceutical context
The contracting process for creating medicines such as opiate based painkillers is a complex one. Regulation is tight and pharmaceutical producers not only must comply with all local drug laws, they also are answerable to United Nations’ narcotics body, the International Narcotics Control Board, during the entire pharmaceutical manufacturing process. Experimentation with genetic engineering of plants used for the creation of pharmaceuticals has added another layer of difficulty and not only in relation to regulation. Intellectual property also needs to be protected.
So if you are a Contract Manager or Legal Counsel working for a pharmaceutical manufacturer how do you manage all the back-and-forth communications in relation to these contracts, ensure you are compliant with all laws, any of which can be updated at any time, and ensure you can access all information about all negotiations and contracts quickly?
You should have a system that at least has the following features:
- Allows for easy construction of multiple contracts that are similar but have minor differences (due to having similar contracts in different jurisdictions);
- Allows contract frameworks to be easily updated to accommodate changes in laws;
- Allows for ‘live’ contracts to be amended easily to comply with updates in regulations and laws;
- Captures all communication and negotiation data so if you need to answer an inquiry of a regulator, all the material you need is at your fingertips;
- Is highly secure.
You may currently use a system to store your completed contracts and work with content creation tools such as Word for the creation of your contracts and use email to negotiate. If this is so, it may be worth exploring a modern contract management system that maintains all your data in relation to one contract in the same place.
A modern contract management system should not only store all your data in the one place, but will also assist you in a dynamic way throughout the whole contracting process -- e.g. it will analyze your past data and make recommendations based on this for future agreements. It will also store your communications in a much more secure fashion than email, allow you to easily pinpoint specific discussions quickly and automatically convert commitments under contract into tasks.
Having all your administrative tasks taken care of in this way will mean that you have more time to consider issues relating to strategy in the negotiation process, such as what the price of of the poppies you may be purchasing should be in relation to the manufacturing of certain opiates, taking into account things such as the political climate at the time of production.
We’d love to hear your thoughts on what is required for the best contracting practice(s) in the pharmaceutical industry! What system do you employ to ensure your contracting is smooth, methodical and you comply with all regulatory and legal requirements? Is it easy to work with, and does it leverage machine learning?
ContractRoom’s system (www.contractroom.com) may be a good fit for your negotiation and contract management process - several pharmaceutical companies are already using it. To learn more about how you too can “negotiate less, agree more” schedule a live, free demo by clicking here: