what next for america - acorn regulatory october 2016
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Dr. Gemma Robinson Managing Director T: 00353 52 61 76706 M: 00353 86 382 6255 E: [email protected]
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INTRODUCTION Dr. Gemma Robinson, Managing Director.
In a campaign that has lasted for years, we still know very little about the policies of both of the main candidates. The dying moments of the 2016 US Presidential campaign have been peppered with 'October surprises', hacked emails and a consistent torrent of 'he-said-she-said' vitriol. Despite the party flags that the candidates are 'travelling under', the electorate knows next to nothing about what a vote for either candidate really means. Businesses, and in particular the life sciences sector, can only look to brief utterances by both candidates for any understanding of what a Clinton or Trump presidency would mean for their sector. Those same utterances are often believed to have been said to garner more populist votes. In the 2016 US Presidential election there are two candidates that, will say whatever they need to say to get elected. It is questionable if they actually believe what they are saying, nevertheless they are saying it to put them in a better place on the path to reaching 270 electoral college votes. This brief document looks at the views, both spoken and printed, of the two main contenders for the Oval office: Hilary Rodham Clinton and Donald J. Trump. As a leading regulatory affairs consultancy firm we will also look at the approaches that both candidates and their parties are taking towards the life sciences sector. The long discussed issue of the Transatlantic Trade and Investment Partnership looms large over the policies of both candidates. Many people believe that at least one of the candidates has shifted position on TTIP over the course of her campaign for reasons of political expediency. We will also look at how one candidate is contradicting himself and sending mixed signals to a confused life sciences sector. If you have any comments on any of the issues raised in this document please get in touch. Likewise, if we can offer any assistance to you with your regulatory affairs projects please feel free to contact us. Dr Gemma Robinson, Managing Director, Acorn Regulatory.
Hillary Rodham Clinton The Democratic Party
Now, at the time of writing, it looks likely that Hillary Diane Rodham Clinton will be the first female President of the United States of America. However, if 2016 has taught us anything, it is that we can take absolutely nothing for granted. The Democratic candidate is poised to take a role that she has long coveted. What does this mean for the life sciences sector? The often bitter campaign saw little in the way of substantive policy debates. Nevertheless, Hillary Clinton has expressed some particular opinions about companies in our sector. Here are the key points of her campaign in relation to the life sciences sector: 1. She believes that there is a need to promote competition by leveraging the USA’s
bargaining power to lower drug costs.
2. The Democratic candidate is proposing an end to “excessive profiteering” by denying tax breaks to companies and to bring the ‘direct to consumer’ advertising tax credit to an end. She is proposing replacing this with a tax credit for R&D activity for companies seeking to introduce new cost effective drugs to the US market.
3. Hillary Clinton has long spoken about the need to bring more generics to the US market and for the pricing structure of generics to be closer to the fees charged in Europe than in the US.
4. She has promised additional budget funding to the FDA to help them to clear their generics backlog in an attempt to bring “more affordable” drugs to the market.
5. There is a plan to ban ‘pay for delay’ practices. These practices are common in the US where a patent holder will pay a fee to a generics company to delay them producing a generic version of a popular drug.
6. While it is clear to many that the former Secretary of State has a more defined and developed policy platform on a number of issues, she has introduced a number of concepts that have caused concern for many in the life sciences industry.
Her plan to introduce a scheme, with the assistance of government agencies, to enable members of the public to privately purchase medicines from other territories (typically through online means) has caused considerable disquiet. The proposal would enable US citizens to ‘safely’ (her word) purchase cheaper medicinal products from territories such as Europe while having some assurances about the quality of the product from a US government agency. Many people believe that the most efficient means of reducing the costs of medicine is to minimise the regulatory burden placed upon manufacturers by the FDA. Overall, the likely victor has done the most groundwork. Her policy credentials are reflected in the consideration that she has given to the industry. It should be noted that she played an active role in healthcare issues during her husband’s presidency. Politically, many see some of her moves in the election season as politically expedient. It could be argued that the strength of support amongst Democratic Party members for her rival Bernie Sanders caused her to reframe many of her positions in relation to ‘big business’. It remains to be seen if she will seek to implement any of the proposals contained herein from January 2017, if elected.
Democratic Party candidate for the President of the United States of America, Hillary Rodham Clinton, speaking at a campaign event in Philadelphia in 2016.
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Donald J.Trump The Republican Party
There has never, in the history of US Presidential elections, been a candidate like Donald J. Trump. He has energised and exercised a base of voters in a way that no one has ever done before. In doing so he has adopted, what many people are saying, is a scorched earth approach. The last days of the campaign have seen him fighting rear guard actions against a multitude of accusers, losing support from those in his party and behaving in ever more erratic ways. His candidacy has owed more to PT Barnum than Abraham Lincoln. And yet, he has taken time to develop policies for the life sciences sector. Some of these fit in to his narrative for the closing days of the campaign about a rigged system and big business. Others, bafflingly, highlight the benefits of importing medicines in direct contrast to his promise to “Make America Great Again”. He has promised much including: 1. A removal of all barriers to allow the importation of cheaper medicines.
2. A demand for greater transparency on prices from drug and device companies.
3. A promise to eliminate the Patient Centred Outcomes Research Initiative. It is hard to assess what impact President Trump might have on the life sciences sector when he is behaving so erratically and emotionally in the closing days of the campaign. Nevertheless, he has a common policy with his immediate rival Hillary Clinton. Both candidates are keen to facilitate the importation of cheaper product from other territories as a means of enabling US citizens to reduce their expenditure on medicines. Trump’s antitrade/anti TTIP campaign has placed a pall over the biggest trade deal in the world. His contradictory comments about creating American manufacturing jobs while advocating the purchase of cheaper medicines from non-US territories is confusing to many.
The removal of FDA restrictions on the importation of products from outside of the USA poses many issues. If President Trump were to introduce a system of a similar scope to that of his rival there would need to be an element of safety and quality associated with the scheme. Spending on medicines in the USA exceeded $400 billion in 2015 and a move to legislate in favour of more cost effective purchasing platforms would see a significant lobbying play on the seats of power in Washington DC. Furthermore, irrespective of the occupant of the Oval Office, the ability of the powerful lobbying platform to slow down or ‘kill’ the introduction of such an act would be significant. The US biopharmaceutical sector employs just under one million people and is a high value element of an economy that is struggling to maintain manufacturing jobs in the 21st century. It is questionable if either of our featured candidates would have the wherewithal or the temerity to introduce such a measure. In short, Donald J. Trump has been low on facts and high on emotion throughout the course of his campaign. As such, it means that we cannot be sure what to expect if he is elected. The early hours of November 9th 2016 will reveal much. Who will lead? Will the vanquished candidate accept the result? From January 2017 the life sciences sector in the USA can be sure of a more ‘robust’ relationship with the occupant of 1600 Pennsylvania Avenue.
Republican Party candidate for the President of the United States of America, Donald J. Trump, speaking at a campaign event in August 2016.
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