Good Business Continuity Practices in Times of Shortages

With the new reality resulting from the pandemic after more than a year, not only our lives but also the productive processes and the world economy have been affected by the measures to restrict mobility and social contact at the risk of becoming ill. This has raised, and in some cases created, new risks related to the supply chain.

Good risk management and the integration of good planning practices for business continuity in the organizational culture of the administration and management group of companies are key factors to face the turbulent scenarios to come and continue supplying medicines and medical devices for the population. 

The industries that manufacture medicines and health supplies are an important source of jobs and an axis for the fulfillment of the policies and health objectives required for people’s well-being. Their continuity and strengthening are strategic for any nation and cannot depend on personal, political or merely monetary interests. The lives of the patients who benefit from this sector rely not only on the quality of medicines and medical devices but also on the existence of sufficient inventories as well as their timely and adequate distribution.

The role of regulatory agencies and the government as a whole is very important to promote the business continuity of manufacturers, distributors and suppliers of raw materials for the manufacture of drugs and medical devices through:

• Agile and flexible regulatory frameworks that adapt to new technological opportunities, market needs and different contexts, particularly those derived from emergency situations.
• Ease of importation of medicines and health supplies in case of emergencies and mechanisms for their correct evaluation and regulatory compliance before entering the market, guaranteeing their quality even in exceptional circumstances.
• Fair conditions of fiscal treatment in the face of new circumstances during and after health emergencies.
• Business intelligence through the use of diplomatic entities to establish links and contacts with industries and suppliers from other countries that expand the opportunities of having alternative supplies if necessary.
• Legal certainty for the proper performance of companies in their purpose, where the national manufacturers are seen as allies in promoting health in Mexico.
• Promotion of the creation of inter-institutional working groups in conjunction with the private initiative for the creation of national strategies that avoid the shortage of medicines and raw materials, attending to and meeting the country's health needs.
• Detection of demand and timely planning of consolidated drug purchases.

On the other hand, manufacturing companies, both of supplies and raw materials as well as medicines and medical devices, must continually prepare to maintain their operations despite contingencies as critical as that which we are experiencing today. The lessons from this past year oblige us to strengthen our preventive culture and plan for the long term, identifying and controlling existing and future risks.

There are many voices (including Bill Gates himself) that echo the fact that new epidemics and economic and natural disasters will come, many of them related to global climate change, the reappearance of old diseases and the strengthening of their transmission vectors. Companies, the government and the population must be prepared for an increasingly difficult and complicated environment.

Among the actions that companies should already be implementing are:

• Incorporate a business intelligence unit in their organizations to coordinate, collect, analyze and classify the information available in the environment that allows the creation of strategic scenarios and improves future decision-making.
• Mapping and thoroughly understand the supply chain up to the second, third and even fourth level, characterizing their interrelationships.
• Design, according to these scenarios, alternative plans for the acquisition of supplies, storage and distribution of medicines and medical devices. Where appropriate, carry out the corresponding regulatory procedures to have the corresponding authorizations for the use of alternative suppliers that require it, as is the case of suppliers of active ingredients.
• Know and classify the necessary inputs for the continuity of production by their criticality, having more than three qualified suppliers for the most critical inputs.
• Establish business alliances with other companies and countries to have alternatives with which to face eventual breaks in the supply chain.
• Support the inventory and budget planning on business intelligence, risk management, and supply chain knowledge.
• Retain reliable suppliers for the complementary services necessary for the fast and safe implementation of alternative plans (such as engineering, validation, analysis, calibrations).

There are many conditions that are at risk from a drug supply shortage. These include cancer, as was evidenced in the much-cited shortage of oncological drugs, and other chronic degenerative and infectious diseases, such as diabetes, hypertension, hormonal problems, triglyceride and cholesterol control, AIDS, orphan diseases and vaccines for other important diseases such as tuberculosis, measles, human papilloma, dengue and influenza.

The issue of drug shortages is so important that organizations such as the international ISPE have created initiatives and groups to combat drug shortages through which problems related to technical, scientific, manufacturing, quality and compliance for the supply chain are addressed as well as the chain’s ability to manufacture and distribute products.