PTSM: Pharmaceutical Technology Sourcing and Management
The pharmaceutical industry provided immediate aid for the relief efforts in Haiti and is proceeding with plans to assist with long-term recovery.
The earthquake that struck Haiti on Jan. 12, 2010, created an enormous humanitarian crisis requiring international organizations, national governments, nongovernmental organizations (NGOs), humanitarian and relief organizations, and the private sector to provide immediate aid and to begin a plan for assisting in the country’s long-term recovery. The delivery of medicines, medical assistance, related equipment, and other medical supplies was and continues to be a critical need. The bio/pharmaceutical industry, through industry associations, companies, and individual employees, have responded to that need through direct product contributions, cash donations, and volunteerism by leveraging existing partnerships with NGOs, humanitarian agencies, and other groups and by applying knowledge gained from other emergency-relief efforts.
Collective efforts
Following the earthquake, pharmaceutical and biopharmaceutical companies donated approximately $35 million for the relief efforts in Haiti, based on member-company participation and information from the Pharmaceutical Research and Manufacturers of America (PhRMA). This total includes donations of relief funds, medicines, and emergency equipment.
An important function of PhRMA has been to serve as a clearinghouse for information on the relief activities of member companies, which it did through the Rx Response program. The Rx Response program was developed in the aftermath of Hurricane Katrina as a way of identifying and implementing the most effective methods for medical-product donations and for coordinating volunteer efforts of medical professionals.
“Rx Response supports the continued provision of critical medicines to patients whose health is threatened by a severe public health emergency such as a natural disaster, terrorist attack, or pandemic that disrupts the normal biopharmaceutical supply system,” explains a spokesperson for PhRMA. “Rx Response, while focused primarily on a domestic crisis, does this through its role as an information-sharing and problem-solving forum for a coalition of biopharmaceutical supply-system organizations, disaster-relief agencies, and local, state, and federal government agencies.” These approaches provided a guidepost and an entry point for the industry’s relief efforts in Haiti. For example, Erin Mullin, director of Rx Response, a pharmacist with a doctorate in biology and immunology and with experience in disaster relief, assisted US government relief efforts on site in Haiti’s capital, Port-au-Prince.
PhRMA is partnered with other groups in the Rx Response program. These include the Biotechnology Industry Organization, the Generic Pharmaceutical Association, the National Community Pharmacists Association, the American Red Cross, the American Hospital Association, the National Association of Chain Drug Stores, and the Healthcare Distribution Management Association.
Beyond responding to immediate crises, “Rx Response members continually monitor news media across the United States to identify potential or realized threats to public health to be able to engage as soon as possible,” says the PhRMA spokesperson. “This response can be pre-disaster, if forewarning exists.” The Rx Response program also is developing new ways for its partners to share critical information internally and with the general public. Examples include the InfoCenter, an online information-sharing forum, and the Pharmacy Status Reporting Tool, which enables those in affected areas to determine the closet open pharmacy in a specific location during a public-health emergency.
Company efforts
Although groups such as PhRMA have played an important role, the core of the bio/pharmaceutical industry’s relief activities in Haiti have been through the work of individual companies and their employees. A sampling of these efforts show how companies developed specific programs to respond to the crisis and leveraged programs already part of their corporate-social-responsibility (CSR) efforts and global health initiatives.
For example, following the earthquake, sanofi-aventis (Paris) donated medicines and vaccines worth nearly EUR 11.2 million ($13.9 million) to NGOs, hospitals, and other organizations such as Tulipe, the Partnership for Quality Medical Donations (PQMD), and the Pan American Health Organization (PAHO). Tulipe, based in Boulogne-Billancourt, France, is an organization whose membership includes large and medium-sized pharmaceutical companies. Its function is to align donations made by pharmaceutical companies in an emergency response to the needs of populations in distress as a result of acute health crises, natural disasters, or conflicts. A key delivery point is the use of kits, or tin trunks, of new medicines that can be provided in a very short timeframe and adapted to the needs in the field. PQMD is an alliance of international medical-product companies, including pharmaceutical companies, and humanitarian agencies focused on the development, dissemination, and adherence to quality standards for medical-product donations to underserved people and disaster victims. PAHO is an international relief agency. sanofi-aventis also worked with the French Embassy in the Dominican Republic and the NGO Aide et Action to provide support, including medical donations, food, and water. In addition, it made an initial emergency donation of EUR 100,000 ($124,000).
Beyond its immediate relief efforts, sanofi-aventis launched an internal funding program, “Together for Haiti,” which raised EUR 450,000 ($556,000) from individual employee contributions, which were matched by the company and further enhanced with a contribution of EUR 1 million ($1.2 million) by the company. These efforts netted financial assistance of EUR 2.0 million ($2.5 million) for six partner organizations involved in the humanitarian relief efforts in Haiti: Aide Médicale Internationale, CARE, the Red Cross, Handicap International, Médecins du Monde, and UNICEF.
Like other companies, sanofi-aventis’s relief efforts are part of its overall CSR efforts and build on its previous experience and related infrastructure from these activities. “Our CSR/humanitarian group department is committed to three action lines: responding to humanitarian emergency situations, responding to long-term needs, and encouraging employee involvement,” says Caty Forget, director of humanitarian partnerships of the CSR Department at sanofi-aventis.
She points to the importance of the expertise and quality of its partners in being able to deliver appropriate responses to the health and social issues that arise in an emergency situation such as the one in Haiti. For example, since 2007, the company has worked with Aide Médicale Internationale, which provides medical and social-support programs for children and adolescents living on the street in Port-au-Prince. That relationship provided the basis for the company to have updated information on the situation in Haiti and allowed it to evaluate and mobilize the efforts of its CSR team with local authorities, hospitals, and NGOs that were on the ground in Haiti, explains Forget. The company learned from other disasters such as the Indian Ocean tsunami in 2004 of ways for improving international coordination. It also gained expertise on how to facilitate its outreach to specific groups, such as severely injured and disabled people, from its partnership with the NGO Handicap International for rehabilitation programs in the Chinese province of Sichuan following the earthquake there in 2008.
Eli Lilly (Indianapolis, IN) initially pledged $250,000 in direct cash contributions following the earthquake. “Half of this amount is for short-term relief, with the balance donated over the next 12 months in support for longer-term rebuilding efforts,” explains Robert L. Smith, Eli Lilly’s senior director of corporate responsibility, and president of the Eli Lilly and Company Foundation, Lilly’s CSR organization. The company’s initial donations were to: Partners in Health, an organization providing healthcare to the poor; World Vision, an association that offers assistance to the poor in developing and developed nations; and Project Hope, an NGO focused on providing healthcare to the poor. The company also has committed to matching employee contributions up to $250,000; thus far, employees have contributed $200,000.
In addition to the company’s direct cash contribution, it made product donations of $4 million. These donations included antibiotics, insulin, and neuroscience drugs. The first insulin shipment was sent to the United States Agency for International Development (USAID), an US federal government agency responsible for administering economic and humanitarian aid.
Bristol-Myers Squibb (New York), its employees, and the Bristol-Myers Squibb Foundation, the company’s philanthropic arm, donated nearly $7 million in cash and products to the earthquake victims. This level included nearly $6 million in medicines, including antibiotics and analgesics, which were shipped to the Catholic Medical Mission Board (a philanthropic organization for global healthcare), Project Hope, and Health Partners International of Canada (a relief and development organization). The Bristol-Myers Squibb Foundation and the company’s employees also committed $800,000 in cash donations to the American Red Cross, the Catholic Medical Mission Board, and Partners in Health.
Novartis (Basel, Switzerland) gave $2.6 million, which included direct financial support for relief organizations operating in Haiti and product donations of essential medicines, including antibiotics and analgesics. Immediately following the earthquake, it worked with the Swiss Humanitarian Aid (SHA) Unit, part of the Swiss Agency for Development and Cooperation, and the Swiss Red Cross. Associates from Novartis worked extra shifts to facilitate sending essential medicines to Haiti with the official Swiss relief-aid mission. The company also provided product donations to the Mexican Red Cross and Health Partners International of Canada. Novartis employees contributed an additional $940,000 to the relief efforts in Haiti, an amount that was matched by the company.
Amgen (Thousand Oaks, CA) and the Amgen Foundation, the company’s philanthropic arm, donated $2 million to the relief efforts. These funds were evenly divided among four groups: the American Red Cross, International Medical Corps, Direct Relief International, and UNICEF. The American Red Cross is providing for basic needs and helped the injured after the crisis. The International Medical Corps is offering emergency healthcare, nutrition, sanitation, and other vital services as well as training for local medical students and healthcare workers. Direct Relief International is providing medical assistance by strengthening in-country relief efforts and providing essential material resources such as medicines, supplies, and equipment. UNICEF has deployed critical supplies to Port-au-Prince and the surrounding areas and also is involved with reuniting children with their families.
Part of Amgen’s relief efforts included using an existing structure to help individual employees to respond to the crisis. The Amgen Foundation has a Disaster Relief Program website that is available for Amgen staff globally who wish to contribute their own funds to designated organizations aiding in the relief and rebuilding efforts. The Amgen Foundation is matching staff contributions dollar for dollar for contributions made from this website. As of May 19, 2010, staff contributions, coupled with matches from the company and the Amgen Foundation, totaled nearly $475,000.
Abbott (Abbott Park, IL) provided $5.6 million in grant funding and donations of diagnostic, nutritional and pharmaceutical products to humanitarian aid organizations. Initial support from theAbbott Fund, the company’s philanthropic foundation, included $175,000 in grants to the American Red Cross, CARE, the Catholic Medical Mission Board, and Partners In Health. Abbott also worked with other organizations to distribute more than $5.4 million in diagnostic, nutritional, and pharmaceutical products such as rehydration solutions, antibiotics, and hand-held analyzers that provide portable diagnostic capabilities. These organizations included: AmeriCares (a disaster-relief and humanitarian relief organization); Direct Relief International; Partners in Health; Heart to Heart International (a relief and development organization); MAP International (a NGO providing medicines to developing countries); Project Hope, and others. These relief efforts were further supported by Abbott’s partnership with Direct Relief International in 2009 prior to the earthquake to pre-position essential products in Haiti to prepare for potential natural disasters. As a result of this work, several health centers in Haiti were able to provide rehydration solutions, antibiotics, and nutritional products supplied by Abbott to people in need immediately following the earthquake.
Pfizer (New York) provided financial and product support after the earthquake through donations to partner organizations that have specific experience in humanitarian-relief work. The company made monetary contributions to CARE and the US Fund for UNICEF and made product donations to the Red Cross, AmeriCares, Project Hope, Direct Relief International, and Heart to Heart International.
As with other companies, matching funds are part of Pfizer’s financial contributions. The Pfizer Foundation, the company’s philanthropic arm, provides a matching-gift program that can be accessed by employees based in the US, including Puerto Rico. The company matches donations on a dollar-per-dollar basis for contributions of $25 to $15,000 per employee. Pfizer also matches 50% of contributions made by Pfizer retirees up to $5000. As of the end of March 2010, these efforts netted almost $400,000 for the relief efforts in Haiti.
GlaxoSmithKline (London) announced initial medical product donations valued at $1.6 million and a cash donation of $408,000 to the British Red Cross for water and sanitation needs. It followed up with those efforts with an additional pledge of $10 million in product donations for antibiotics, respiratory and diabetes treatments and also donated consumer products such as toothpaste, vitamins, and pain relievers. In addition, through its PULSE program, employees took on additional responsibilities to support emergency-response partners.
Looking ahead
But as responsive as pharmaceutical companies have been, there is the recognition that long-term relief will be required. “I went to Haiti in mid-April, three months after the quake, and could measure the big challenge to build Haiti with a transformative agenda to help this country, one of the poorest countries in the world, to gradually take responsibility for its own future and reverse the dramatic circle of poverty,” says sanofi-aventis’s Forget. “There are encouraging signs of progress, but there is a still a long way to go.”
Companies are beginning to focus their CSR efforts on the recovery process in Haiti. Novartis, for example, is approaching its Haiti assistance as a longer-term effort as it “wants to leave a sustainable success,” says Leopold Wyss, head of sponsoring and donations at Novartis. Novartis formed a committee to identify possible project partners to assist in reconstruction efforts. The committee consists of Novartis International, the company’s corporate entity; BASAID, a contraction for “basic aid,” which is the company’s employees’ development-aid association, and the Novartis Foundation for Sustainable Development, the philanthropic arm of Novartis. The committee held a preliminary meeting in early March to discuss two areas of activity–children and health–for which possible project partners and projects could be identified.
The committee identified several key criteria, including working with an aid organization that is locally based in Haiti, that demonstrates long-standing commitment to the country, and that has requisite experience. “It is also agreed that the project should satisfy the criteria of sustainability, effectiveness, and transparency,” says Wyss.
With those criteria, the committee is currently assessing a project that aims to help displaced and disadvantaged children in Gonaïves, a community north of Port-au-Prince. “Currently, a major problem is the schooling of children who escaped from Port-au-Prince with their families or as orphans,” says Professor Klaus Leisinger, executive director of the Novartis Foundation for Sustainable Development. “The deeply traumatized refugee children, in particular, need help to be able to get back to some semblance of normality.”
The project seeks to provide schooling for traumatized children, attend to their psychological needs, and provide regular meals. “The project will also make a point on involving impoverished local people in the work to ensure that needs are met across the board and that no one group of disadvantaged people is singled out for preferential treatment, something that would only exacerbate social tensions,” says Leisinger. The committee that has been created to evaluate the project application will accompany it throughout its different stages.“The hope is to eventually leave a project that continues to make a difference to many poor people’s lives,” says Leisinger.
Pfizer is evaluating how its employees may contribute long-term through Pfizer’s Global Health Fellows program, whereby Pfizer employees volunteer with NGOs for periods ranging from three to six months. The company has worked with several of its NGO partners to develop job descriptions to work on long-term relief efforts. To date, the company has not placed a fellow in Haiti, but is continuing to review the program with the goal of making matches in the near future.
Relief organizations, governments, and international organizations also emphasize the need for long-term and sustained assistance. As of mid-April 2010, the American Red Cross, one of many relief organizations working in Haiti, had raised more than $409 million. It had spent approximately $111 million, with about 50% of the money spent on emergency relief, such as food and relief supplies; 39% for shelter; 5% for livelihood development through activities such as cash assistance; 5% for water and sanitation; and 1% percent for health. The association said in an Apr. 12, 2010, release that it expects to spend $200 million, or roughly half of the total amount it had raised as of mid-April, to meet immediate needs and to allocate the remaining $200 million for long-term recovery. During the next three to five years, it expects to apply 39% of total funds raised for shelter; 18% for emergency relief; 17% for water and sanitation projects; and 16% for helping families rebuild their lives through grants, loans, and other financial assistance. Other spending areas in the multiyear plan include helping communities prepare for future disasters such as floods, hurricanes, and earthquakes and strengthening health programs.
Speaking before the International Donors Conference Toward a New Future for Haiti, held at the Union Nations headquarters in New York on Mar. 31, 2010, UN Secretary-General Ban Ki Moon summed up the level of commitment needed for Haiti. “As we move from emergency aid to long-term reconstruction, let us recognize that we cannot accept business as usual,” he said. “What we envision, today, is wholesale national renewal, a sweeping exercise in nation-building on a scale and scope not seen in generations. In partnership with the United Nations, Haiti's leaders are committing to a new social contract with the people.”
Clinical Supply Planning in Europe - Balancing Cost, Flexibility and Time
December 19th 2024The packaging and distribution of clinical supplies is a fundamental piece to the overall success of a clinical trial, and advance preparation can help establish a more efficient supply chain. Selecting the best geographical location for those activities, however, depends on the clinical trial protocol, business decisions, and even the investigational medicinal product (IMP) being studied.