Ireland’s prowess in the world of pharmaceuticals is well chronicled — at least nine of the top 10 chemical and pharmaceutical companies in the world, including Pfizer and Wyeth, have operations here. More than 120 overseas companies employ 20,000 people with exports of up to US$32bn every year from these shores, comprising 29pc of Ireland’s total exports.
Some 47 finished pharmaceutical plants are in operation, of which 24 have satisfied the rigorous quality and environmental requirements of the US Food and Drug Administration (FDA).
With its own ongoing evolution as well as advances in the fields of life sciences, biotechnology and even nanotechnology, the pharmaceutical industry is moving towards bespoke, targeted treatments for various illnesses and medical conditions rather than the bulk methods of bygone days when pharmacists would dispense powders and pills right in front of the customer.
Instead, a more just-in-time, manufactured-to-order process is about to grip the industry and the changes will be quite obvious on the high street. In Ireland, the evolution that is gripping the pharmaceutical industry is already making a pronounced impact. The arrival and subsequent expansion of the Boots chain of chemist outlets as well as the arrival and acquisition of 22 traditional pharmacies by German pharmaceutical chain Gehe marks the first phase of a specialist, bespoke future.
According IBM Business Consulting Services, in 2010 the pharmaceutical industry will not only make white powders; it will sell a variety of products and therapeutic healthcare packages that include diagnostic tests, drugs and monitoring devices as well as a wide range of services to support patients.
Companies that learn how to make ‘targeted treatment solutions’ will deliver bigger shareholder returns than ever before. Drug discovery and development will be underpinned by an understanding of how different diseases function both at a molecular level and as part of a biological system. Molecular sciences will enable the industry to define diseases more accurately and to create a collection of treatments and services for patients with specific disease subtypes, rather than one-size-fits-all drugs for patients with similar symptoms but essentially different diseases.
At the coalface of the pharmaceutical manufacturing industry in Ireland, very much a significant part of the complex supply chain that is the global pharmaceutical business, every conceivable enterprise application goes into making the entire process run on time, just in time. Enterprise resource planning (ERP), document management, environmental management and process control technologies keep the various plants operating seamlessly and at the same time satisfying the demanding paper trails expected by the FDA as well as the local Environmental Protection Agency (EPA).
“The work is complex,” explains Dermot Walsh of IBM, formerly a partner at PricewaterhouseCoopers before IBM acquired its consulting business last year. “For the Irish pharmaceutical industry there is a number of business characteristics that need to be satisfied. Regulatory compliance requires rigidity and discipline. If we’re talking about the evolution consuming the industry in terms of a broader product set and much smaller batch sizes, every operation needs to be more agile and flexible.”
Walsh’s colleague, Brendan Lawlor, explains: “Historically, at a manufacturing level, the maintenance of master batch records is a requirement that is set in stone. For this reason document management is becoming a key technology for the pharmaceutical sector.
“Every time a new version of a product comes along, a document management solution is needed to manage the workflow, in terms of keeping a record of every step of the process to keeping to an official way of doing things. Managing this electronically will prove vital in terms of reducing the lead time of production. Because you are producing drugs that people will consume, there are rigorous process controls and production records that must be kept at all times for inspection by the FDA and the Irish Medicines Board.”
Walsh continues: “At a manufacturing process level, most of the industry is now based on ERP, because it is part of a global supply chain. The industry has traditionally been cautious in its use of technology, but as it moves forward there is a compelling need to be more innovative in the use of technology.”
“In approaching the targeted treatment vision, e-business technologies will be the glue that will hold the supply chain together,” says Lawlor. “The commercial drivers of the industry will be flexibility and agility and firms will rely heavily on electronic batch records and document management to meet regulatory guidelines. This will be more and more crucial in an on-demand pharmaceutical and drug culture.”
An example of the growing reliance of the pharmaceutical industry on IT is the recent decision by Procter & Gamble (P&G) to enter into a 10-year contract with Hewlett-Packard (HP) valued at US$3bn to manage P&G’s IT infrastructure, data centre operations, desktop and end-user support, network management and some applications and development support for the company’s global operations in 160 countries. The industry knows where it’s going, and that it means business and is prepared to invest.
Brian Fenix, marketing manager at HP Services in Ireland, confirms that the P&G deal has been closed and signed and that it will pave the way for 2,000 P&G employees joining HP. “In the various verticals we cover, the pharmaceutical sector is one of the biggest and quite open to some of the newest technologies, particularly in the area of converged networks and IP telephony,” he says. “Many of the greenfield sites of major pharmaceutical companies require the latest technologies and existing pharmaceutical companies see the wisdom of converging their data and voice requirements.”
“ERP is a crucial technology for many of the pharmaceutical companies we deal with in Ireland. Overall, the industry, as it moves toward the targeted treatment environment, is being quite courageous in its uptake of new technology at an enterprise level,” Fenix adds.
At the other end of the spectrum, the impact of targeted treatments and on-demand drugs ordering, the necessary changes will be felt hardest at the high street chemist, which has been undergoing steady change. The arrival of Boots and Gehe has shaken up the entire sector and the likelihood of remaining independent pharmacies and chemists having to band together and establish co-ops is increasingly likely. As well as this, the old days of chemists dispensing drugs according to a doctor’s prescription is undergoing rapid change. Pharmacies will rely more heavily on centralised electronic medical records management and proof of identity for the dispensing of drugs and treatments, and as well as this will be less likely to carry much stock in their stores.
Tallaght-based software firm Systems Solutions was established 15 years ago to develop pharmacy management software. Today its technology is in use in 65pc of all Irish pharmacies and 10pc of UK pharmacies. The company recently secured a major contract with Boots, in which its technology has been deployed in some 1,400 stores. The company’s technical director and founder, David Raethorne, explains: “Automated or robotic dispensing technologies are being deployed in remote locations and there is little need for pharmacies to hold stock on-site. Everything will be real-time, just in time, whereby the entire supply chain, from the doctor to the chemist, will be electronic. The result is less space for stock and more room to focus on the business of selling.”
Systems Solutions’ QuickScript product, which is based on Windows 2000 and SQL server database technology, enables pharmacies to access medical records irrespective of where they are located to ensure that the people who require the drugs are able to obtain them in the right quantity and in a targeted manner. “It also enables interaction checking. One drug might interact badly with another drug so it is important to ensure that pharmacists are informed at all times,” Raethorne adds.
“We’ve completed a strategic review of the way that the industry is going and how the entire supply chain will develop electronically, and the aspect of manufacturing to order is a very real prospect. Bulk product will disappear and so too will the wholesalers — United Drug is already diversifying to survive. A direct electronic link between the manufacturer, the pharmacist and the end-user is already forming,” Raethorne concludes.
By John Kennedy