Generics manufacturers have called for European leaders to move drugs manufacturing out of India and China to help stabilise the medicines supply chain.
An open letter from the executive committee of Medicines for Europe — a representative body for European generics manufacturers — to the next European Commission (EC) on medicines shortages addressed the “great concern” caused by stock shortages.
Published on 26 November 2019, the letter said that although the provision of generic medicines has increased access to medicines in Europe, “cost containment, industrial factors and new regulatory requirements threaten that”.
As a result, the committee called on the EC “to prioritise shortage prevention in pharmaceutical policy during its first 100 days” by implementing four recommendations.
These included a call to “engage ministries of health and industry to identify policies to stimulate investment in manufacturing”, which would involve providing “guidelines on medicines procurement under the EU procurement directive, including how to recognise investments in security of supply for Europe”.
Warwick Smith, director general of the British Generic Manufacturers Association and a signatory to the letter, told The Pharmaceutical Journal that this relates to the move of active pharmaceutical ingredient (API) manufacturing “from Europe to India and to China”.
“We are now getting to the stage where even if this doesn’t cause shortages, it makes the supply chains more fragile,” he said.
An investigation by The Pharmaceutical Journal in August 2019 revealed that half of all safety warnings from European and US drug regulators are issued to drug manufacturing sites in India and China, raising concerns over the fragility of the global supply chain.
“There is an argument for looking at the supply chain top to bottom,” Smith said, adding that the moves to manufacture API outside the UK “have been as a result of government policy decisions”.
“So maybe we’re at the time when they need to be reviewed and see if we can attract manufacturing, certainly back to Europe, and maybe some back to the UK,” he suggested.
However, Smith noted that the number of shortages in the UK “is broadly normal”, when compared with the level of shortages in other countries, such as Switzerland, where “there are many hundreds of shortages”.
He said this was partly due to generics manufacturers being able to “increase their prices to cope” with an increase in the cost of goods.
“In many of the European countries, they can’t [do this] because the price is fixed by the authorities,” he added.
The Labour Party’s 2019 general election manifesto pledges to create a state-owned generics manufacturer if the part forms the next government.