This article is written by Aarlin Moncy, pursuing a Diploma in Advanced Contract Drafting and Negotiation and Dispute Resolution from LawSikho. This article will explain the concept of quality agreement, and guide you in drafting an effective quality agreement for a pharmaceutical company.
A contract in any industry or for any business is one of the most essential components, and carrying on a business or any kind of collaboration without a contract can be a nightmare for all parties involved. When parties enter into a contract, all their obligations and other clauses of the contract become binding upon each of the parties, and in case of a breach of any of the clauses, the one committing the breach becomes liable. So, contracts make the parties accountable to each other, hence, the quality of work gets better.
As we are living in this age of pandemic, there has been a rise in the consumption and production of drugs. From hoarding and black-marketing of medicines, the courts directing the concerned authorities to increase the production to the incredible growth in stock prices of pharmaceutical companies, within a single year we have seen and experienced so much. In this article, we will be focusing on quality agreements, as the name suggests, these agreements are extensively used for quality assurance of the drugs in the pharmaceutical industries.
What is a quality agreement?
The quality agreement isn’t similar to any other agreement, rather these agreements have come under scrutiny from the concerned authorities worldwide, especially in India, as third party drug manufacturing hasn’t been defined under the Drugs and Cosmetics Rules, hence the liability of the third party involved in such agreements was a big question.
Quality agreements are entered into by two or more people for the purpose of manufacturing, supply, and service while maintaining the quality of drugs and not compromising on them. These agreements are made primarily to comply with the quality of the drugs that are to be manufactured and also to comply with the regulations imposed by the government and/or to comply with the statutory obligations or as per the concerned authorities.
One of the reasons why parties enter into such agreements is to expand their reach in the global market, to survive in the age of globalisation, businesses outsource contractors for manufacturing drugs at cost-efficient prices. India is one of the examples, where foreign pharmaceutical companies land up in the search of cheap labour and resources. Generally, the quality assurance department headed by the quality risk manager, along with the legal department of the pharma company and the contractor/vendor (manufacturer, laboratory, etc), collaborate together while drafting a quality agreement.
The scenario in India : before and after the 2020 amendment
In India before the 2020 amendment of the Drugs and Cosmetics Rules (“DCR”), drug marketers/distributors were not legally recognised which created huge confusion whether these quality agreements were legally enforceable or illegal in India or not, as the earlier rules didn’t have any provisions relating to the liability of the third party involved in such arrangements.
After the amendment to the DCR, contract manufacturing of drugs especially in India has become more transparent and there is more accountability of the parties involved in such agreements. From now on, both the drug manufacturer as well as the drug marketer or the distributor is now liable under the Indian laws. Hence, these agreements must be made with proper assistance and cooperation from all the parties in order to comply with all the required regulations as well as to provide the customers with the best possible product.
Why do parties enter into such agreements?
Quality agreements are stand-alone agreements, and they shouldn’t be read like an addendum or an attachment of the main agreement. This is because of the format and the language used while drafting these agreements. Regarding the question as to why parties enter into such agreements, while having the main agreement, then why do the parties need another/separate agreement, while these questions are normally asked by thousands of contract drafters. Now this question doesn’t have a single answer, however, the answers or the opinions are convincing.
Now as we know that these agreements’ main purpose is to make sure that the quality of the product is as per the recognised standards and are not compromised for the sake of making profits, as these agreements deal with drugs, and drugs are essential goods/commodities in a person’s life. While manufacturing them, or testing them at laboratories, one has to keep in mind that they are doing a public service, although the only way to encourage these industries is by giving incentives, and in order to promote such development in these areas, it can only be done if these industries are not restricted by the authorities and are given reasonable freedom to make profits. The United States of America is the right example, as it doesn’t have any regulations regarding drug pricing, hence, the prices of drugs are way too high, as compared to the Indian drug’s prices, as India has a regulation regarding drug pricing.
Therefore, we can understand that the pharma companies go under huge pressure because of the government intervention or the laws laid down, the compliance issues and different approvals that these companies have to undergo in order to manufacture and as well as while releasing these drugs into the market.
Things to keep in mind while drafting a quality agreement
While drafting a quality agreement, the parties have to keep few things in mind:
1. Scope and purpose clause
This is the most important clause in the entire agreement, as it states the entire scope of work and purpose or the intent of the parties for which they have agreed to enter upon this agreement. This clause needs to be drafted properly keeping in mind the target and the final goal for which the parties have joined or collaborated. In case this clause hasn’t been drafted precisely or the parties haven’t drafted the clause as per their verbal agreement, then such situations can lead to major differences between the parties further creating disputes/conflicts between the involved parties. It is very important to customise the clause as per the mutual understanding of the parties so that future conflicts can be easily minimised.
2. Definitions and interpretation clause
In this clause, the terms which have been used multiple times or the terms that convey more and have a wider ambit as per the agreement. Such terms can be mentioned under this clause so that the parties can easily interpret and understand such terms more comprehensively, therefore minimising confusion and conflicts regarding the interpretation of such terms and clauses.
3. Roles and responsibilities clause
In this clause, parties should mention their roles and responsibilities as per the agreement. It is very essential that parties elaborately mention each of their roles as well as their responsibilities to contribute and fulfill the purpose and scope of the work as per the mutual agreement between the parties. In case if this clause is taken for granted and vaguely drafted, it can result in differences between the parties, and ruin the relationship of the parties by creating conflict between them. To prevent such disputes relating to the role or responsibility of any of the party, this clause should be drafted keeping in mind all the formal discussions, facts stated by each of the party, promises/covenants by each of the party, purpose, and scope of the agreement
4. Resolution of disagreements clause
Now it can’t be denied that if parties are entering into an agreement, though the parties know that they have to cooperate with each other and fulfill all their roles, responsibilities and further comply with all the clauses and the laws, it obvious that during the term of the agreement, there will be a time that parties won’t agree with each other and such disagreements can be regarding the quality of the drugs, while auditing or inspecting, etc. During such disagreements, parties will have to resolve and come to a conclusion else the purpose of the agreement would get defeated and to prevent such events, it is mandatory to include a clause stating a mechanism or process or steps to resolve such disagreements and differences between the parties.
5. Assignment clause
In this clause, parties have to mention that neither of the parties shall have the right to transfer or assign their roles, responsibilities, and promises/covenants to any other third party, as it would defeat the present agreement’s purpose.
6. Term and termination clause
Under this clause, the parties shall mention the term of the agreement, and whether the same agreement can get revised or extended during or before the expiry of the term. Further parties can include or make a separate clause regarding the termination of the agreement, whether the agreement can or cannot be terminated unilaterally, and under which circumstances, the parties will have the power to terminate the agreement, etc.
Parties can include other clauses too as per their preference and can customise the entire agreement as per their mutual understanding. As there isn’t any proper formatting of a quality agreement, but certain clauses are a must, and the most important thing that the parties should always keep in mind, whether they are drafting a quality agreement or any other type of agreement, the parties should draft the agreement in such a way that there isn’t any space which would lead to communication barriers or restrict communication between the parties, as communication is the major factor that would lead to a success story or a major failure!
By now you might have an idea about what a quality agreement is, why parties refer to such agreements, and the important or the basic clauses that are to be included while drafting one. Now one more important thing that shouldn’t be ignored while researching or drafting or assisting someone in drafting a quality agreement is that these agreements should be drafted keeping mind the parties that are involved, other factors such as the scope of the work, the control under the agreement, as to who has the major control in the agreement, the ways or modes of communication, the importance of inspection and auditing with the respect to the materials used, basically the entire agreement shouldn’t be an online template or a previously used temple, rather it should be a customised agreement catering the needs of the parties because resolving conflicts can get expensive at times.
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