Open letter challenges EU Commission on medicine supply chain
In an open letter to the European Commission, Medicines for Europe calls for a new medicine security contract with their goal to improve access to medicine and ensure a secure supply chain to Europe.
Due to the major disruption of the last few years, the pandemic, the economic downturn, the increasing energy crisis, and massive geopolitical turmoil, availability of medicines is at serious risk in the EU, and could lead to a major shortage.
The increasing costs of raw materials, manufacturing, packaging, and transport are making it more difficult to meet demand, especially as price caps applied to medicines are not being equally adjusted in line with inflation.
Medicines for Europe are adamant about the occurrence of further shortages in medicines in 2023, and in this open letter to the European Commission, call for EU regulators and member states to reform and work on contingency plans to mitigate these very real risks.
The letter initially details the root cause of supply chain issues, mostly putting it down to a series of cost reduction tactics and price caps, alongside an increase in demand meaning a scale-up in production, which is necessary and expected, even with the aforementioned cost reductions. Medicines for Europe stress that there is no capacity in the supply chain for meeting a surge in demand, leaving them vulnerable.
Events of the past few years, granted many unforeseen, have left the pharmaceutical industry on it’s knees due to a lack of effective mitigation.
Brexit facilitated the severance of the UK (a major player in the market) from the EU; the COVID-19 pandemic led to the addition of costly new hygiene measures, that had to be put in place whilst the demand on the industry to develop and scale up medicines had never been higher. The invasion of Ukraine by Russia added to the demand for emergency medicine, while the resulting rise in inflation crippled companies due to capped pricing as part of the EU measures. The COVID-19 policy in China disrupted supply chains, the result of which has been felt by companies on a global scale. All of these impacts have been absorbed by the pharmaceutical industry, leading to a build-up of economic stress.
Medicines for Europe have responded to this crisis with a series of suggestions for short- and medium-term mitigation strategies.
Short term
1. Regulatory flexibility
As the industry proved during the pandemic, given certain exceptions, a surge in demand can be met. What we need to do now is to learn from this – what worked and what didn’t – and apply this to updated regulations for a range of situations. Emergency use approval of drugs, packaging flexibility to be able to reallocate drugs, and changes to measures pertaining to shelf-life and localised regulations.
2. Open a conversation around generic medicines and cost of inflation
Currently EU member states are polarised on the issue, with some overturning laws to ensure prices can change to reflect inflation, and others are leaning into further price reductions under the guise of clawback taxes. Some open communication could lead to a healthy compromise.
3. Improving preparedness around demand surges by more data sharing
Informing the pharma industry about potential shortages earlier can allow for adaptions to optimise the supply chain for greater efficiency. Sharing of epidemiological data can also help to predict outbreaks of infectious diseases and ready the industry to meet a spike in demand in a certain field.
Medium term
1. Increasing the efficiency of the EU Pharmaceutical Strategy
The letter suggests that processes should be consolidated and standardised across platforms, removing archaic steps though automation and digitalisation. This would come along with a commitment to take advantage of big data in the industry and use the information provided to better mitigate risk factors.
2. Secure the supply chain in generics
By putting in place legal guidance in regard to implementation of supply criteria in the Public Procurement Directive. They also encourage The Commission to confer with the Transparency Commission on the possibility of re-imaging the Transparency Directive in the context of providing security in the supply chain. Similar measures have already been implemented in other countries, such as Canada and Germany.
3. Diversification in manufacturing
Especially towards more green technologies. Aid and investment will depend on how flexible and innovative the industry shows it can be, with the production of medicines and APIs through greater automation and more sustainable processes. Things that would also help to secure the supply chain and respond to changes in demand.
Medicines for Europe stresses that they don’t intend to encourage a reactionary response from the EU on this matter, with little consideration for long term effects, but rather coming up with a plan with durable strategies for the industry.
The letter concludes with:
“Europe is facing major shortage risks this year. We want to work with you to make short- and medium-term changes to prevent medicine shortages in the future. We look forward to working with you on a new contract for medicines security in Europe.”
To read the full letter to The Commission click the link below.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance