Coordinated Global Solution Needed To Ensure Universal Vaccine Supply, Speakers Say

Shortages of vaccines are a worldwide problem with tremendous impact on health, affecting countries of all income groups and regions, speakers said at a recent industry event. Different possible solutions for shortages of vaccines were suggested during the panel discussion.

The Geneva Forum on medicines and vaccines shortages was organised on 28 April by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

According to Anders Vinther, chief quality officer, Sanofi Pasteur, and chair of the IFPMA Heads of Quality Group, and Tania Cernuschi technical officer, Vaccine Pricing, Supply, and Procurement at the World Health Organization, shortages of vaccines is a rising problem. In 2015, 20 percent of children worldwide did not receive lifesaving vaccines, according to the WHO Immunization Highlights 2015. Sixty percent of all vaccines are the object of a shortage or are at risk. Even basic vaccines such as tetanus are not everywhere available, Cernuschi said.

A shortage occurs when the right product is not available in the right quantity, at the right time and the right place against the right conditions. Shortages occur at several points in the supply chain from manufacture to procurement and distribution. However, this definition is not globally accepted, Vinther said. Cernuschi highlighted that the lack of a global definition of shortage prevents an adequate assessment of the problem.

Vinther emphasised that a shortage of vaccines impacts immunisation and leads to missed opportunities to vaccinate children. Shortages prevent UNICEF from living up to its promises towards children, said Ann Ottosen, senior contracts manager in the UNICEF Supply Division. UNICEF has a high interest in the prevention of shortages as it is the biggest buyer of vaccines worldwide.

Causes of shortages

Shortages are a complex problem to which many different factors contribute. As each vaccine market has its own specificities, a shortage of different vaccines may be caused by different factors, Cernuschi said.

The outbreak of a disease is one possible cause of a shortage of vaccines. An increase in demand can create a tension between supply and demand, which may ultimately result in a shortage.

The common high concentration of producers of vaccines leads to a low spread of the risks. If one manufacturer does not manage to supply, other manufacturers may not have the capacity to absorb the failure, said Luc Besanҫon, CEO of the International Pharmaceutical Federation.

Other factors that contribute to shortages are the global production, parallel import and export, and the inability to pay. The specific organisation of tenders and the manner of delivery of vaccines contribute to the shortage problem as well, according to Besanҫon.

One of the other major causes of vaccine shortages is, according to Vinther, the regulatory complexity for vaccines, notably for post-approval changes.

The regulatory framework for vaccines has become increasingly complex, as each country has a different set of requirements for specific products and packaging, he said. Every country performs a scientific assessment of vaccines and has its own form for manufacturers to fill in. This complexity increases substantially the period of time before a new or modified vaccine can enter the different national markets.

A mutual reliance by countries, regulatory convergence or universal scientific assessment of vaccines would foster the availability of vaccines on the market and decrease the risk of shortages, Vinther said. But, he added, no compromise should be made on the quality of vaccines.

Elements of a Possible Solution

Whereas shortages are a global problem, they are still mainly treated at national level. Member states have different strategies to avoid the interruption of vaccination programs, according to Cernuschi. A global coordinated solution of shortage is required to ensure that everyone has access to vaccines. A robust solution to shortages requires that all the different causes are addressed, Cernuschi said. She warned that an adequate solution will inevitably be very complex.

Early warning systems of manufacturers, monitoring systems, reporting systems and documentation requirements could be part of the solution to the problem of shortages, speakers said. An improvement in the procurement and planning schedules is desired as well. Improvements also need to be made in the area of forecasting of the demand of vaccines, said Cernuschi. New technologies and platforms may provide some help to establish these systems, she said.

Cernuschi emphasised the need for collection and sharing of information. Ottosen urged the industry to be open and transparent about the possible risks of shortage, both on the manufacturing level and on the country level. The sooner the risk of a shortage is communicated, the sooner measures can be taken to prevent an actual shortage.

Besanҫon suggested to remove all regulatory burdens. He furthermore proposed the establishment of a single institution or body that is in charge of shortages as this would help to maintain an overview of shortages.

As the shortage of vaccines is a highly complex problem, no fast solution can be expected, the panellists concluded. None of the stakeholders alone will be able to provide a solution. An open and continued dialogue and cooperation between all key stakeholders in the health sector is required to ensure that everyone has access to the vaccines he needs, they said.

Resources on the event provided by IFPMA are below:

–          Short video highlights of the event (2 minutes)

–          Edited version of our panel discussion

–          Infographic on shortages

–          Infographic from visual facilitator

–          IFPMA Interview series with Anders Vinther

Elise De Geyter is an intern at Intellectual Property Watch and a candidate for the LLM Intellectual Property and Technology Law at the National University of Singapore (class 2017).

 

Image Credits: William New