Jobs Today: Cures Tomorrow—Innovation and the Biopharmaceutical Industry

Jobs Today: Cures Tomorrow—Innovation and the Biopharmaceutical Industry

Click here to view the full report.

Click here to view the executive summary.

Executive Summary

Our nation’s biopharmaceutical industry is vital to the personal health of our people and the economic health of our country. At the current time, and in the current political and regulatory environment, we are at the edge of a precipice: We can either adjust our policies and remain the international leader in biopharmaceutical development and manufacturing, or we can watch the industry move overseas, like so many before it. It is a harsh reality, but one that is simultaneously rife with opportunity.

The unions and companies of the Pharmaceutical Industry Labor-Management Association (PILMA) recognize that, especially in the current economy, America needs a sustainable and growing biopharmaceutical industry. Directly and indirectly, our industry supports jobs for 3.2 million people in all 50 states. But, without changes to our national industry-related policies, these jobs may ultimately leave the U.S. to relocate in other countries, where environments are friendlier.

To be sure, there is no easy fix — a wide variety of policies has contributed to where we are today, and a wide variety of reforms will be required to ensure the American biopharmaceutical industry’s continued preeminence. Policies include tax regulations, intellectual property rights, economic and trade policies, patent laws and data exclusivity, importation laws, and education programs, to name a few.

Challenges & Opportunities

America’s position in the world market has slowly eroded over many years, and other countries, like China and India, are standing by to pick up the slack by making significant investments in talent, infrastructure and research. But, as we know, our nation never fights harder or wins more than when it’s facing a second-place finish. That’s why, in many ways, this is an opportunity.

First and foremost, we must prevent other countries from using their friendlier economic and tax policies to entice American biopharmaceutical companies to their shores. Because we are in an environment where tax revenues are a central focus of policymakers, we must, at least, guard against tax policies that would diminish our already fragile competitive position. We believe America’s global leadership position will be in danger unless we establish policies that encourage sustained innovation and growth.

Medical innovations in general and biopharmaceutical advancements in particular, have traditionally been drivers in the knowledge-based economy. The U.S. remains the global leader in biopharmaceutical development, in part because of the American biopharmaceutical industry’s research and development achievements, but also because American biotechnology employment represents more than half of all such jobs worldwide. Indeed, the vast majority of global biopharmaceutical R&D investment is domestic. Clearly, if steps aren’t taken to maintain this leadership position, however, good jobs and the health of the American people are at stake.

Economics & Trade

While the biopharmaceutical research industry is firmly positioned to continue its contribution to America’s economic growth and health, other countries are offering strong challenges to America’s preeminence. Other countries’ dramatic growth can be inferred from their domestic research and development expenditures, their share of new U.S. patents, and the number of new doctorates in science and engineering being awarded to their citizens. A recent study found that the U.S. ranked last among 40 countries and regions when it comes to progress made over the last decade toward the “new knowledge-based innovation economy.” In terms of overall competitiveness, the study ranks America sixth, behind Singapore, Sweden, Luxemburg, Denmark and South Korea.

Our laws and regulations must be updated to match the complex nature of new products being developed. Traditional patent and data exclusivity protections, for example, are no longer sufficient to protect the intellectual property of innovators. At the same time, ongoing threats to intellectual property protection – in the form of legislation, court decisions, and more – could potentially undermine the value of patents in the future. In order to foster continued development and ensure the right incentives for innovation, manufacturers in the research-intensive biopharmaceutical sector must be able to rely on the certainty afforded to them through strong and enforced legal protections.

Next, we must fight even harder to prevent illegally imported medicines from entering our national drug supply. There are serious, well-documented concerns related to the quality, safety and efficacy of these unregulated, often counterfeit biopharmaceuticals. We must protect our drug supply just as vigilantly as we do our water supply, because contamination of either could mean a major national health problem. Additionally, the counterfeit drug industry is estimated to cost hundreds of thousands of legitimate jobs annually.

Americans must also insist on free trade that is fair trade. Trade policies are major determinants of the competitiveness of America’s biopharmaceutical industry. We cannot allow the continuation of the trade policies that have hampered, and ultimately destroyed, other industries, such as steel, automobiles, and textiles.

We have the opportunity to create jobs and strengthen U.S. global competitiveness by both promoting and expanding biopharmaceutical industry investment in research and development and manufacturing in America. To do that, we need to ensure that we institute tax policies that improve incentives for companies to undertake the unpredictable and expensive process that leads to the creation of tomorrow’s therapeutic breakthroughs. And, simultaneously, we must renew efforts to make sure America has fostered the talent to research, discover and manufacture biopharmaceutical innovations well into the future. This can be achieved by addressing the full formal education pipeline in science, technology, engineering and mathematics from kindergarten through 12th grade, in vocational/technical schools, labor/management training, college, and graduate university programs.

The Obama Administration has already launched many of the starting initiatives to accomplish these long-term aims. The administration has set a goal of doubling America’s exports over the next five years, and called for boosting investments in R&D, increasing funding for biomedical research, investing in the next generation of scientists and engineers, and creating a national infrastructure-innovation and -finance fund.

JOBS RIGHT NOW: Hope for Tomorrow

While we have these opportunities to strengthen our international leadership position, fight off our competitors, and create new jobs for thousands of people, we cannot forget that our country’s biopharmaceutical industry exists with one person in mind: the patient. As referenced by the Congressional Budget Office (CBO), “Many examples exist of major therapeutic gains achieved by the industry in recent years … anecdotal and statistical evidence suggests that the rapid increases that have been observed in drug‐related R&D spending have been accompanied by major therapeutic gains in available drug treatments.” This research and these jobs translate into better patient outcomes.

We work every day to develop treatments that reduce the need for hospitalizations, lessen the length and intensity of rehabilitations, and potentially even save lives. But, perhaps most importantly, we — as an industry — provide hope for patients whose lives depend upon our discovering breakthrough treatments, and we must remain mindful of preserving, and even improving, patients’ access to them. Imagine a world where smart anti-cancer therapeutics will kill cancer cells and leave their normal neighbors untouched, or where nanotechnology will deliver drugs precisely to the desired tissue. That world is not too far in the distant future. Surely our nation can move on from today’s economic challenges, but we cannot forget the importance of protecting Americans’ health care and quality of life.

PILMA: Patent Reform

PILMA: Patent Reform

March 8, 2011

The Pharmaceutical Industry Labor Management Association applauds tonight’s decisive action by the Senate in passing the 2011 Patent Protection Act. The strong 95 to 5 vote is a solid indication that the bill meets the concerns from both sides of the aisle. This measure will unlock U.S. innovation and support good jobs. It provides the framework for simplifying the patent protection process while enhancing U.S. competitiveness. We congratulate Chairman Leahy for his work in developing this legislation and his determination in seeing it through to passage. PILMA will continue to support this bill as it moves to the House, working with our friends on both sides of the aisle to make sure that it is not weakened as it goes through the legislative process.

A strong patent system is crucial to American competitiveness as the country focuses on job growth and rebuilding.

Intellectual property—such as patents—provide three key factors that help drive the economy: they promote incentives for innovation; they provide holders with certainty regarding their rights; and they provide enforcement tools to defend one’s property. Biopharmaceutical innovation is costly and risky. However, by maintaining a predictable and reliable patent system, Senator Leahy’s bill, in its current form, would help to encourage the innovation that provides jobs and leads to real and significant healthe benefits for America’s patients.

From PILMA’s Jobs & Innovation Report – Patent Reform

Pages 8-9

IP protections and their enforcement ensure inventors and innovative companies that their investments in time, money, and human capital will be protected if they are successful, and that they will have the opportunity to earn a potential return on their investment. For the biopharmaceutical sector, investments in R&D require certainty, security, and predictability, as well as a clear and stable legal environment.

Reforming the patent application and approval process must protect the integrity of the system and ensure appropriate exclusivity for creators, so that their creations may drive innovation and create jobs. We must be vigilant that America’s patented innovations are protected and strengthened. The biopharmaceutical industry is among the most advanced technological sectors in the world economy, and is heavily dependent on strong, vigorously enforced intellectual property rights as a means to balance the substantial risks involved in R&D with the promise of appropriate rewards for success. Unless such rights are protected from infringement, we are in danger of losing one of America’s foremost industries.

Other countries are studiously observing our developing patent reform policy. We need to be careful that we don’t improve our competitors’ positions rather than strengthening our own. Public policy changes that would allow public access to patented information early in a patent’s protected period, coupled with early non-court-based patent challenges, would facilitate international competitors’ challenges of our patent rights. Further, such action would be costly and tie up the patent holder with challenges during a substantial portion of the use-and-sell period.

Other Resources

PILMA’s resolution on patent reform [to be added].
Summary of the America Invents Act
Comments from Senator Patrick Leahy on Floor Schedule for Patent Reform Act.
Washington Post Editorial: Why the Patent Process Should be Overhauled [to be added].

Reaction to the President’s State of the Union Message from Michael J. Sullivan, PILMA Chair

Reaction to the President’s State of the Union Message from Michael J. Sullivan, PILMA Chair

January, 2011

“As we saw tonight, the momentum exists to advance a national innovation agenda, one that stands to benefit millions of union members. But now comes the hard part: what can the administration and Members of Congress specifically do to translate this into new jobs and a higher quality of life for working Americans? The president did a great job of selling the need for a greater focus on innovation and competitiveness, but to do so we must identify which specific sectors and policy areas stand to have the greatest short and long-term impact here at home. In other words, where do America’s working families have the most to gain? How can we continue to bring business and labor together?

We believe the answer lies in a strong medical innovation agenda that takes advantage of our greatest resource: the American worker.”

Michael J. Sullivan is General President of the Sheet Metal Workers International Association, AFL-CIO, and serves as Chair of the Pharmaceutical Industry Labor-Management Association.

PILMA Vows to ‘Redouble’ Support for Increased Protections Against Intellectual Property Theft

PILMA Vows to ‘Redouble’ Support for Increased Protections Against Intellectual Property Theft

2011

WASHINGTON, D.C.—Labor and management in the biopharmaceutical industry will “redouble efforts at the federal level to support increased protections to fight intellectual property theft, counterfeiting and piracy, along with real enforcement measures to implement those protections.”

In a resolution [link to resolution] unanimously adopted by the trustees of the Pharmaceutical Industry Labor-Management Association (PILMA), the group applauds the ongoing efforts by labor and industry to erect strong intellectual property protections and to enforce those standards vigorously. The resolution points out that the pharmaceutical sector is “one of the few manufacturing industries that still maintains a significant employment footprint domestically, supporting more than 3.2 million American jobs.”

As part of this commitment to intellectual property rights, PILMA has been advocating for years in support meaningful reform of the United States’ patent system. PILMA commended Congress’ recent passage of the America Invents Act as an important step in the right direction. Looking forward, PILMA will increase its advocacy efforts on behalf of the PROTECT IP Act, a bill that will strengthen enforcement against rogue websites that sell counterfeit products, including unsafe medications.

“PILMA will join ongoing collaborative efforts—both within the business community and the trade union movement—to protect our knowledge-based economy, innovation industries and affected U.S. workers by fighting intellectual property theft, counterfeiting and piracy at every level,” the resolution declares.

Chaired by Michael Sullivan, former President of the Sheet Metal Workers International Association, PILMA is composed of unions and employers in the pharmaceutical industry working together to promote industry employment, innovation and legislation affecting working families.

Building Trades Seek Meaningful Debate on Puerto Rico Tax Increase Legislation

Building Trades Seek Meaningful Debate on Puerto Rico Tax Increase Legislation

October 29, 2010

Puerto Rico Law 154 would impose special taxes on non-resident individuals and companies operating in Puerto Rico. The law would be detrimental to the skilled men and women in Puerto Rico construction trades unions since this could lead to a decrease in local jobs and infrastructure investment.

Michael Sullivan, President of the Sheet Metal Workers’ International Union, sent the following letter to the the Honorable Luis Fortuno, Governor of Puerto Rico, urging an open discussion surrounding the proposed law.

Click here to read the letter.

Maryland’s Coming Bioscience Revolution

Maryland’s Coming Bioscience Revolution

September 16, 2010

Fred Mason, President of the Maryland AFL-CIO, wrote the following op-ed published in The Bowie Star regarding the emergence of the life sciences industry in Maryland and its far-reaching economic benefits.

“The high-paying jobs that this industry creates aren’t just in science. Highly skilled construction workers are needed to build bioscience plants. Accountants are needed to balance the books. Electricians, plumbers and other skilled tradesmen — good union workers — are needed to keep these facilities running.”

Click here to read the full article.

Pennsylvania Sen. Bob Casey Visits SMWIA Local 19 Joint Apprenticeship & Training Center

Pennsylvania Sen. Bob Casey Visits SMWIA Local 19 Joint Aprenticeship & Training Center

September 10, 2010—PILMA, in conjunction with We Work For Health, co-sponsored a September 10th visit by Pennsylvania Sen. Bob Casey to Sheet Metal Workers Local 19 Joint Apprenticeship & Training Center in Philadelphia. The session showcased the strategic partnership between the biotechnology industry and labor for some 35 biotech professionals and representatives from PILMA’s labor and industry partners—including SMWIA, GlaxoSmithKline, Endo Pharmaceuticals and Pfizer.

This was the first of several planned site visits to familiarize industry officials with the skill levels and training that various union craft workers bring to specialized construction challenges in the biotechnology industry.

“I applaud PILMA for a partnership that is a win for workers and industry. This type of training and cooperation can be an inspiration to policymakers. Giving workers the skills that employers require helps workers succeed and grows the regional economy.”

– Senator Bob Casey