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Intellectual property (IP) is a pharmaceutical or biotech company’s most valuable resource, and its protection is a key to that company’s future success

Pharmaceuticals companies must face the daily challenge of creating value through the exploitation of IP rights, but avoiding considerable reputational harm. companies have become more aware of the potential damage that can be caused by too strict an interpretation of IP rights. Working in collaboration with national governments, trans-national organisations such as the WHO, and non-governmental organisations such as the Bill and Melinda Gates Foundation, pharmaceuticals companies have begun to find ways through the minefield of IP protection in less developed countries

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The pharmaceutical industry is experiencing a period of heightened regulatory scrutiny both in the US and globally.

The industry’s regulators (both in the US and globally) have also provided guidance that enables innovation and potential cost savings in manufacturing operations. A thorough understanding of the new guidance (e.g., the FDA’s Process Analytical Technology initiative or “PAT”) and a commitment to embed it in the way companies work can bring competitive advantage and prepare the industry for the future as today’s guidance is translated into tomorrow’s regulation

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The high profitability of pharmaceuticals companies makes them a relatively easy target for healthcare providers trying to reduce costs

What impact is the pressure on prices having on pharmaceuticals companies, and what are they doing to combat it? On the one hand, the company that develops a truly innovative drug with proven improvements in safety and efficacy can still, after careful evaluation of the market, demand premium prices and secure an excellent return on investment. On the other hand the reality is that with such breakthrough products being few and far between, even the most innovative pharmaceuticals companies are learning to live in a more cost-conscious environment, with margins under continuous pressure.

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As drug pipelines among major pharmaceutical manufacturers have become less productive, many companies have increasingly sought to establish a variety of partnering arrangements

Companies spend significant amounts of time and resources researching and negotiating various alliances. However, many companies fail to effectively monitor the royalty and other revenue streams that are negotiated with their partners and as a result, often leave significant amounts of revenues on the table. This lack of monitoring is often the result of poor coordination among legal, accounting/finance and sales departments as well as the turnover of personnel responsible for oversight.

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For many years, the pharmaceutical industry was highly regarded for its role as a leader in the advancement and improvement of human health

 For many years, the continuous introduction of new and improved drugs has also driven substantial revenue growth in the industry. But there have been a number of recent product recalls despite well established quality assurance processes and regulatory requirements. These, incidents have led many consumers to believe that pharmaceutical manufacturers have lost sight of their original vision, and instead of focusing on bettering the human condition, are more interested in bettering their profits.

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Pharmaceuticals Industry Challenges

How PwC can help you

To profitably manage their businesses in this environment, manufacturers will need to consider a new model that embraces fundamental change to the organizational structure, operating practices and corporate culture that prevails in companies today. In the future, successful enterprises will be those that can efficiently adapt to new regulatory requirements, changing markets and develop and sell the next generation of breakthrough therapies while working to ensure that the hard-won bond of trust between the industry and its stakeholders remains strong.

As is the global leader serving pharmaceutical and life sciences companies, PricewaterhouseCoopers has extensive experience working with organizations across the industry, including: proprietary and generic drug manufacturers, specialty drug makers, medical device and diagnostics suppliers, biotechnology companies, wholesalers, pharmacy benefit managers, contract research organizations, and industry associations. We have aligned our practice with the broader health industries market to ensure that our people are well versed in the relationships between suppliers, providers, payers, and customers. We have made a deep commitment to understanding the forces that are impacting these sectors and developing and delivering solutions that help our clients’ achieve their financial, operational and strategic objectives.

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Claudio Yarza

Claudio Yarza

Partner, Assurance Life Sciences & Pharma Practice Leader

Tel: +972 3 7954835

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