Cancerworld Magazine
  • About the Magazine
    • About us
    • Editorial Team
    • Events
    • Archive
    • Contacts
  • Articles
    • Policy
    • Practice Points
    • Delivery of Care
    • Biology basic
    • Medicine
    • Featured
  • Contents
    • News
    • Editorials
    • Interviews to the Expert
    • In the Hot Seat
    • Profiles
    • Obituaries
    • Voices
  • ESCO Corner
SUBSCRIBE FOR FREE
Facebook
Twitter
LinkedIn
Cancerworld Magazine
Cancerworld Magazine
  • About the Magazine
    • About us
    • Editorial Team
    • Events
    • Archive
    • Contacts
  • Articles
    • Policy
    • Practice Points
    • Delivery of Care
    • Biology basic
    • Medicine
    • Featured
  • Contents
    • News
    • Editorials
    • Interviews to the Expert
    • In the Hot Seat
    • Profiles
    • Obituaries
    • Voices
  • ESCO Corner
Cancerworld Magazine > Articles > Policy > First voluntary licensing of cancer drug sets ‘vital precedent’ for the industry
  • Articles
  • Policy

First voluntary licensing of cancer drug sets ‘vital precedent’ for the industry

  • 16 November 2022
  • Esther Nakkazi

An agreement between Novartis and the Medicines Patent Pool to facilitate production in LMIC countries of generic versions of on-patent nilotinib is boosting efforts to improve access to essential cancer medicines.

First voluntary licensing of cancer drug sets ‘vital precedent’ for the industry
Total
0
Shares
0
0
0
0
0

The first voluntary licence for a patented cancer medicine was signed last month on the fringes of the 2022 World Cancer Congress in Geneva.

The agreement between the pharmaceutical company Novartis and the Medicines Patent Pool – a UN backed public health organisation – will allow manufacturers to produce generic versions of nilotinib, a cancer medicine used to treat people with chronic myeloid leukaemia (CML) who are resistant to, or cannot tolerate, imatinib (Glivec).

It follows the example of similar voluntary licences that have been negotiated with the Medicines Patent Pool in other disease areas such as HIV/AIDS and hepatitis C, and is expected to result in widening access to the drug among patients in low-income, and even some lower-middle income, countries.

The nilotinib agreement was brokered within the context of the Access to Oncology Medicines (ATOM) project set up earlier this year by the Union for International Cancer Control.

“This is the first time that we’re seeing that this voluntary licence model can be adapted and applied to cancer,” Melissa Rendler-Garcia, ATOM Coalition Project Leader, told Cancerworld. “It allows for a reduction in price sometimes by over 50–90%, which is translated into being able to be accessible and affordable for patients, particularly in low income countries,” she said.

“When you look at the Medicines Patent Pool, and you look at what they’ve been able to do for access to HIV medicines and TB – that model has worked very well, to make sure that those medicines are easily accessible and very cheaply. We want to do the same for cancer and this is the first time that that’s going to happen,” she said. “We are  going to use that as an example to keep on really working with the private sector, the industry, big pharma to be able to negotiate with other voluntary licences for other medicines in the future.”

“That model has worked very well for access to HIV medicines and TB. We want to do the same for cancer”

Charles Gore, executive director of the Medicines Patent Pool, welcomed the opportunity to add a cancer drug to the list of treatments for which voluntary licences have been agreed. “Access to high-quality cancer medicines is a crucial component of the global health response to the cancer burden, therefore I am delighted to be signing our first licence agreement with Novartis for a much-needed cancer treatment in low- and middle-income countries. Although the remaining patent life is relatively short, this voluntary licence in the non-communicable disease space sets a vital precedent that I hope other companies will follow.”

The agreement has been welcomed by Pat Garcia Gonzalez, founder and CEO of the Max Foundation, an international advocacy group that for the past 25 years has been supporting CML patients across the globe and helping them access the treatment they need.

“There is a very critical problem for access to CML treatment and diagnostics in low-and middle-income countries, and all creative strategies are needed to improve the situation,” she says.

“Generic manufacturers will need to come forward to produce and deliver these drugs, and patients will need to be able to afford them”

“Innovation in creating availability to medicines is critical and this first voluntary licensing of a cancer drug is an important step for industry. We hope it will encourage more pharmaceutical companies to innovate and consider new ways to help all patients get the medicines they need,” she says.

She warns, however, that the agreement will only make a difference if it results in more and cheaper generics actually making it to the market. “For this approach to succeed in helping CML patients, we will need generic manufacturers to come forward to utilise the license to produce, contract and deliver nilotinib, and understand that many governments in the low-income world are not prepared to procure these drugs so patients will need to be able to afford them.”

‘Affordable’ in the case of nilotinib means affordable within the everyday family budget, as the drug – as with all CML tyrosine kinase inhibitors – will generally have to be taken for the patient’s entire lifetime.

John Collins Kamili is executive director and chief pharmacist at Cipla Quality Chemical Industries, one of the largest pharmaceutical manufacturers in sub-Saharan Africa, located in Kampala, Uganda, which manufactures generic drugs for a number of indications including HIV/AIDS, malaria and hepatitis. Currently it produces no cancer drugs – but that is set to change, with the opening of a planned new oncology facility, says Kamili.

He points out that oncology treatments are among the most dynamic in terms of research and new medicines, and that most cancer drugs are therefore currently under patent protection. Even in low-income countries like Uganda, which are able to use certain exemptions to the World Trade Organization TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement, access to technology to manufacture generic cancer drugs is very difficult, he says. “So voluntary licensing is the quickest way to close the technology gap.”

Cipla is already manufacturing antiretroviral drugs for HIV under a Medicines Patent Pool arrangement, with these generic drugs being restricted to markets in ‘least developed countries’ (as designated by the UN).

For Dennis Olodi, Ag. Executive Director of the Uganda Cancer Society, it is the prospect of enouraging production at local levels that he sees as offering the greatest impact on improving access to cancer medicines. “Cancer services are over centralised. If this licensing will cater for devolution of medicines to the lower facilities, then it will go a long way in bridging drug delivery gaps,” he says. “It will help support the existing procurement and medicine supply systems.”

“If this licensing will cater for devolution of medicines to the lower facilities, it will go a long way in bridging drug delivery gaps”

There may be limits, however, to how far the patent pooling model that has delivered well for HIV and other diseases can work for cancer. A survey published in the Lancet Oncology at the end of 2021 showed that the priority drugs listed by oncologists working in low and lower-middle income countries – the ones they felt would help them deliver the most for their patients – were primarily not the more recent drugs that are still protected by patents. What they want – and often lack – are the basic chemotherapy ‘workhorse’ drugs: anthracyclines, taxanes, platinum drugs, alkylating agents. Despite these having been off-patent for years, even decades, access remains hugely challenging.

“Among the top 20 medicines selected by oncologists in low-income and lower-middle-income countries, between 13% and 68% of respondents indicated that accessing each of these drugs placed patients at risk of catastrophic expenditure,“  reported the authors. “This was the case even for older generic cytotoxic drugs such as doxorubicin and cisplatin, with 27% of oncologists reporting a substantial risk of catastrophic financial expenditures for doxorubicin and 21% for cisplatin. Of the top 20 medicines listed for low-income lower-middle-income countries, dexamethasone was the only medication that was universally available for more than 50% of respondents.”

The Lancet study raises questions both about how far access programmes should focus on new generations of cancer drugs, and about assumptions that when a drug comes off patent, affordable generic versions become accessible in lower-income countries. Access to cancer medicine requires manufacturers like Cipla to start supplying affordable generic nilotinib, but also the many other cancer drugs that are at the top of oncologists’ priority lists.

Total
0
Shares
Share 0
Tweet 0
Share 0
Share 0
Share 0
Related Topics
  • Essential cancer medicines
  • generics
  • LMICs
  • Medicines Patent Pool
  • patents
Esther Nakkazi

Esther Nakkazi is a freelance Science and Technology Reporter. She writes for various media outlets around the globe and is also a media trainer and mentors journalists in science reporting and blogger at Uganda ScieGirl. She is the founder of the Health Journalists Network in Uganda. 

Previous Article
  • Obituaries

Michael Sporn: A pioneer in prevention and a unique and special friend

  • 4 November 2022
  • Adriana Albini
View Post
Next Article
  • News

Knowing ‘functional prognosis’ helps cancer patients plan unfinished business

  • 16 November 2022
  • Janet Fricker
View Post
You May Also Like
View Post
  • Biology basic
  • Profiles

Miriam Merad and the 2025 Sjöberg Prize: A Celebration of Innovation in Cancer Immunotherapy

  • Yeva Margaryan
  • 6 May 2025
View Post
  • Delivery of Care
  • Senza categoria

Istanbul, Ankara take action on HPV vaccination, as government delays promised national programme

  • Marwa Koçak
  • 1 April 2025
View Post
  • Medicine

Could this dual approach be the frontier that finally gets immunotherapy to work for MSS colorectal cancer?

  • Amalya Sargsyan
  • 31 March 2025
View Post
  • Featured

Sleep & Cancer: Why Rest Matters More Than You Think?

  • Adriana Albini
  • 23 March 2025
View Post
  • Articles
  • Policy

Owning our successes is how we secure the future of Europe’s Beating Cancer Plan

  • Anna Wagstaff
  • 7 March 2025
View Post
  • Articles
  • Delivery of Care

Seeking to get pregnant when the cancer is advanced

  • Diana Mwango
  • 1 March 2025
View Post
  • Articles
  • Delivery of Care

How Indian centres slashed treatment drop-out rates in childhood cancer

  • Swagata Yadavar
  • 20 February 2025
View Post
  • Articles
  • Delivery of Care

China’s integrated cancer care guidelines ‘reflect self-confidence’ in the field of oncology

  • Tina Jiang
  • 15 February 2025
search
CancerWorld #101 Download CancerWorld #101 Download CancerWorld #101 Download or search in Cancerworld archive
Newsletter

Subscribe free to
Cancerworld!

We'll keep you informed of the latest features and news with a fortnightly email

Subscribe now
Latest News
  • Personalised neoantigen vaccine for kidney cancer shows promise in phase 1 study
    • 8 May 2025
  • What Caught Our Eye in April: Oncology’s Top Moments
    • 7 May 2025
  • CancerWorld #102 (April 2025)
    • 22 April 2025
  • What Caught Our Eye in March: Oncology’s Top Moments
    • 8 April 2025
  • Ovarian cancer: mechanism conferring resistance to immunotherapy revealed
    • 21 March 2025
Article
  • Miriam Merad and the 2025 Sjöberg Prize: A Celebration of Innovation in Cancer Immunotherapy
    • 6 May 2025
  • Istanbul, Ankara take action on HPV vaccination, as government delays promised national programme
    • 1 April 2025
  • Could this dual approach be the frontier that finally gets immunotherapy to work for MSS colorectal cancer?
    • 31 March 2025
Social

Would you follow us ?

Contents
  • Miriam Merad and the 2025 Sjöberg Prize: A Celebration of Innovation in Cancer Immunotherapy
    • 6 May 2025
  • “I really care about people.” – Philip Kantoff, A Life in Science and Medicine
    • 5 May 2025
  • What If the World’s Leading Prostate Cancer Epidemiologist Opened a Restaurant? A Conversation with Lorelei Mucci- A Harvard Scientist, A Mother, A Leader
    • 23 April 2025
MENU
  • About the Magazine
    • About us
    • Editorial Team
    • Events
    • Archive
    • Contacts
  • Articles
    • Policy
    • Practice Points
    • Delivery of Care
    • Biology basic
    • Medicine
    • Featured
  • Contents
    • News
    • Editorials
    • Interviews to the Expert
    • In the Hot Seat
    • Profiles
    • Obituaries
    • Voices
  • ESCO Corner
Cancerworld Magazine
  • About us
  • Articles
  • Media Corner
  • Privacy Policy
  • Cookie Policy

Cancerworld is published by OncoDaily (P53 Inc.) | Mailing Address: 867 Boylston st, 5th floor, Ste 1094 Boston, MA 02116, United States | [email protected]

Archivio Cancerworld

Input your search keywords and press Enter.