Targets, takeovers and Tomb Raiders: things to watch in 2019 global health policy
As if to remind us how intertwined politics, economics and health care are in 2019, the year begins with the second-worst Ebola outbreak in history in the Democratic Republic of Congo (DRC) during an election campaign, with the World Health Organization’s efforts to respond compromised by protests and a worsening security situation, and the announcement of another mega takeover in the life sciences industry.
Global economy and politics
This year will be significant because in 2019 one-third of humanity is scheduled to go to the polls in democratic general elections.
Countries including Afghanistan, Argentina, Australia, Canada, India, Indonesia, Israel, Nigeria, Poland, South Africa, Ukraine as well as the DRC will be holding national elections this year and the European Parliament is also having its elections. Opinion polls suggest that at least a few of these countries could see a change of government this year.
So, at a time when there is much global debate, particularly in the West, about the effectiveness of democracy; the ‘strong man theory’ of politics; the ability of governments to manage social, economic and environmental change; immigration; data and privacy, one-third of the world’s population will have a chance to have their say and vent their spleen.
These elections are happening against a backdrop of weakening global economic growth, heightened uncertainty, a downturn in many major economies, ongoing trade tensions between the US and China and debates about the benefits of globalisation. Global trade, industrial production and business confidence all fell in 2018 to finish significantly lower. There’s also a question whether the G20 countries would even have the same commitment to cooperate internationally to support the global economy if there was a need for collective policy action in the same way they did 10 years ago in response to the Global Financial Crisis.
The rebalancing of interest rates in high-income countries after the GFC a decade ago, resultant increased borrowing costs together with higher debt levels may see pressure on the corporate sector. There may even be some high profile business failures as the era of cheap finance comes to a close. This, together with many major stock markets registering falls in 2018, is contributing to greater uncertainty in the global economy.
It’s also not beyond the realms of possibility that Britons may go to the polls this year, three years ahead of schedule, if the British Government falls amid the ongoing Brexit saga as the United Kingdom plans to leave the European Union in March.
And finally, believe it or not, this year the campaign for the Republican and Democratic primaries for the 2020 US Presidential election will heat up, this being the first Presidential election since Donald Trump was elected in 2016.
One issue in the Republican primaries will be whether Trump runs unopposed for the Republican nomination. For the Democrats, the debate will be whether a non-traditional candidate should get the nomination, with the suggestion that 2020 will be the year of female Democratic candidates. Even Oprah Winfrey and Angelina Jolie have been floated or hinted as potential Democrat candidates.
Winfrey or Jolie running for President might seem fanciful at first. However, with the worldwide rise of disruptive, left-of-field candidates in democracies where voters are losing trust in traditional politicians, together with issues like the #metoo backlash for gender equality, gun control, immigration, refugees, healthcare and the value of international cooperation on things like trade and climate change being debated, it’s not inconceivable that either could run.
Could we see the original Tomb Raider running against Trump for US President in 2020?
In 2019 the global health policy agenda will be dominated by several major issues. The provisional agenda for the January 2019 World Health Organization Executive Board meeting gives a flavour of what issues might be front of mind in the global health discussions this year.
Preparation for future health emergencies will continue this year during the centenary of the Spanish Flu Epidemic and at a time of the Ebola outbreak in the DRC, whilst the agenda of the WHO has broadened as non-communicable diseases (NCDs) have become a more important global health issues alongside infectious diseases.
Maintaining momentum on implementing the United Nations Sustainable Development Goals on health, including global targets on universal health coverage (UHC), will be a feature of global health debates in 2019.
This year will be important with the growing realisation that by the end of 2019 we will only have 10 years left to achieve the 2030 SDG targets, including those in health. Hopefully this will help focus the minds of governments and other stakeholders on the need for progress.
The WHO’s assessment is that overall progress on some of the health SDGs has been positive in areas like reducing under-five year old mortality, increasing coverage of HIV treatments and reducing deaths from tuberculosis.
In other areas such as in malaria, drug-resistant tuberculosis, alcohol use and air pollution progress has stalled. In some areas, like NCDs, there are many countries that will have real difficulty in reaching the goal of reducing pre-mature death by one-third by 2030.
Universal Health Coverage (UHC) will continue to grow in importance as a feature of the global health agenda. More governments are elevating this as an important policy issue at the political level. For example, in Kenya UHC formed part of the government’s re-election agenda and UHC is an election commitment for the Indian Government in the lead up to India’s forthcoming election in April/May.
Moreover, the first ever UN High Level Meeting on UHC in September in New York will throw the spotlight on progress on implementing UHC around the world, how to finance it, and how stakeholders can work together to implement it.
Source: World Bank. 2018. “Lack of Health Care is a Waste of Human Capital: 5 Ways to Achieve Universal Health Coverage By 2030”, 7 December, http://www.worldbank.org/en/news/immersive-story/2018/12/07/lack-of-health-care-is-a-waste-of-human-capital-5-ways-to-achieve-universal-health-coverage-by-2030, accessed 1/1/19.
The debate over drug pricing will continue in 2019 with the focus perhaps shifting more towards the pricing of cancer medicines. Papers going to the WHO peak bodies, together with the release in mid-2019 of the next update of the WHO's Model List of Essential Medicines, the High Level Meeting on UHC and the growing priority of treating non-communicable diseases could highlight these issues.
Watch for the accompanying campaigns by activist groups as they switch their focus from HIV and hepatitis C drugs to use cancer medicines to critique the pharmaceutical industry. The drug pricing debate is now drawing in high-income countries as well as low- and middle-income countries, announcements by the Trump Administration and debates in the US being a case in point.
International cooperation on medicines regulation will continue to be a theme this year as well. In January, ministers of the African Union are expected to endorse the creation of a new African Medicines Agency which will implement pan-African medicines regulation. Meanwhile the UK will be working out how to ensure continued cooperation with Europe’s regulatory agency, the European Medicines Agency, after the latter moves to the Netherlands as part of the UK’s anticipated Brexit departure from the European Union in March. Another area in health policy that may get more attention is the process of getting biosimilars approved to provide competition to new biologic medicines.
Some of these international health policy issues will be influenced by the events in the global economy and politics through 2019.
An economic downturn may limit governments’ ability to fund healthcare, a debate amongst US presidential candidates could influence the international policy dialogue, or a possible failure of the UK Parliament to support the current deal on Brexit due to unrelated concerns about the Ireland-Northern Ireland border could see the UK crash out of the EU with no deal and potential medicines shortages.
Life sciences industry
Changing health policy can also affect the commercial operations of life sciences companies, as demonstrated by the major fall in share prices of Chinese pharmaceutical companies towards the end of last year on the back of major changes to China’s medicine pricing policies.
In the industry itself, 2019 starts with the announcement three days into the year of a US$ 74 billion acquisition of Celgene by BMS, less than a month after Takeda’s shareholders approved its US$ 62 billion takeover of Shire.
For about a month Takeda was due to be the 9th largest pharmaceutical company by sales, but BMS now looks like taking this label with the announcement of the Celgene deal.
The BMS/Celgene deal forms a larger company focussing particularly on cancer, while the Takeda purhcase of Shire demonstrates the continuing internationalisation of Japanese pharmaceutical companies.
Last year saw for the first time China approve a new medicine for sale before it was approved in western countries, another sign of China’s growing importance in the international life sciences sector.
Last year also saw a record number of US FDA approvals for new and generic medicines approved, with 55 new molecular entities approved.
Possible drugs that could get first time approval in 2019 include the first oral treatment for type 1 diabetes patients, new Parkinson’s Disease treatments, drugs to prevent infectious diseases and even cannabis-derived therapies for pain management.
Meanwhile major drugs that will likely start to experience patent expiries this year include Novartis’ Gilenya which was the first oral formulation drug developed for multiple sclerosis, Allergan’s Restasis for treating dry eyes, and Takeda’s Uloric for treating gout.
Another trend we are likely to see is the continuing ‘crowding’ of some classes of cancer drugs as more new medicines come to the market to compete against existing patented cancer treatments such as the PD1-L1 inhibitors and PARP inhibitors.
It will be interesting to see how this competition affects both the pricing of medicines and policy debates about drug pricing. As with developments in medicines to treat hepatitis C, it might be another example of why ‘me-too’ medicines and market competition are good things for both innovation and competitive pricing.
All of this will make for an interesting 2019.
Happy New Year.