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.

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 

 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. 

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 

Partnership for Quality Medical Donations (PQMD)

. 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 

 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: 

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: 

, an organization providing healthcare to the poor; 

, an association that offers assistance to the poor in developing and developed nations; and 

, 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 

 (a philanthropic organization for global healthcare), Project Hope, and 

 (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, 

, 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: 

 (a disaster-relief and humanitarian relief organization); Direct Relief International; Partners in Health; 

 (a relief and development organization); 

 (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. 

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.

 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.”

Articles

CSR and Sustainability Forum

The pharmaceutical industry provided immediate aid for the relief efforts in Haiti and is proceeding with plans to assist with long-term recovery.

The Pharmaceutical Industry Comes to the Aid of Haiti

As part of an initiative to increase transparency at the US Food and Drug Administration, FDA issued last month a report detailing public comment and outlining 21 draft proposals for improving disclosure policies at the agency. Several proposals related to pharmaceutical manufacturing and the supply chain, including suggestions on disclosure relating to import procedures, inspections, and Warning Letters. In the next phase of its transparency initiative (Phase 3), FDA will consider the input it received from regulated industries in evaluating ways in which FDA can improve transparency and efficiency while reducing costs. Later this summer, FDA plans to issue a report that incorporates Phase 3 draft  proposals. All draft proposals will be open to further public comment as the agency evaluates these proposed recommendations. FDA had formed a task force as part of an initiative by the agency to gather and evaluate input on ways it could improve its transparency.

 The May report outlined current import procedures for drugs, food, and other products regulated by FDA. These procedures require importers to file information about the product with the United States Customs and Border Protection and other jurisdictions. FDA is authorized to refuse admission of imported products into the US if the products appear to be adulterated or misbranded. FDA discloses the name of the foreign manufacturer responsible for the refused product, the date of refusal, and the description of the product, as provided by the manufacturer, on the FDA website. The information is updated monthly and can be searched by country of origin or by product. 

 Public input for these import procedures included a suggestion to require FDA to post all responses, status, and correspondence related to products that are detained at the border as well as those that are subsequently released by FDA. Another suggestion was to post all import refusals by FDA’s Office of Regulatory Affairs (ORA) in a searchable database to allow information about refusals to be searchable by pathogen, year, or country. 

 In considering these suggestions, “the task force considered whether additional disclosure of information about import procedures will give the public a better understanding of FDA activities to protect the food and medical-product supply,” said the report. The task force raised concerns over whether such disclosure would deter imports in general. It also considered whether further disclosure of information on products detained at the border would be useful because detaining a product at the border does not necessarily result in not admitting the product into the US. 

 After considering these issues, the task force issued a draft proposal for public comment on increasing disclosure in its import procedures. The draft proposal asserted that “FDA should disclose the outcome of filer evaluation for importers or third parties working on behalf of importers,” said the report. “Disclosing the outcome of filer evaluations will likely increase accountability among actors in the supply chain,” said the report. The report pointed out that such information could also be helpful for regulatory entities that conduct inspections using a risk-based approach to set priorities in their inspection efforts. 

Public disclosure regarding inspection information by FDA was another important item addressed in the report. FDA currently conducts inspections of establishments that manufacture, process, pack, or hold FDA-regulated products before approving those products and/or before those products are on the market to determine the establishment’s compliance with FDA regulations. If “objectionable conditions” are observed, FDA issues a Form 483, which lists the name of the firm, the date(s) of the inspection, and the observations made by an investigator during inspection. FDA provides an initial classification of the inspection based on its observations: official action indicated (OAI), voluntary action indicated (VAI), and no action indicated (NAI).

If no enforcement action is considered or after enforcement is concluded, FDA provides the establishment with a final inspection report, an Establishment Inspection Report (EIR), which provides a history of the findings, including any action taken by FDA and/or the establishment, any refusals, voluntary corrections, or promises made by the firm, and copies of the related documents issued to the firm when it received the Form 483.  FDA posts Form 483s and EIRs in ORA’s electronic reading room on the FDA website when a high level of public interest is anticipated. FDA redacts non-public information, such as trade secrets, from the inspection before posting it. 

 Several suggestions from the public concerned ways to improve the timely posting of these reports. Other suggestions involved using the reports as a means of identifying inspection trends by FDA to better understand “FDA’s concerns that may drive inspectional observations and other citations,” said the report.  In assessing these comments, FDA concurred that additional disclosure may provide the public with a better understanding of the supply chain and information about the firms from which they are purchasing products. It also felt that such information would be helpful for companies in their compliance efforts. Balanced against these benefits were concerns that further disclosure of information may be misleading in instances where a Form 483 is issued, but the violations do not affect public health and therefore do not require further action by a firm. 

After weighing these factors, the task force issued a draft proposal recommending FDA to disclose the name and address of the entity inspected, the inspection date(s), type of FDA-regulated product involved in the inspection, and the final inspectional classification (i.e., OAI, VAI, NAI) for inspections of clinical trial investigators, Institution Review Boards, and facilities that manufacture, process, pack, or hold, any FDA-regulated product that is currently marketed. The draft proposal is not specific about the timing of when this information should be disclosed but only asserts that “disclosure of this information should  be timed so as not to interfere with planned enforcement actions,” according to the report. 

In issuing the draft proposal, FDA asserted that disclosing information about inspections increases public understanding, increases accountability by firms, creates incentives to correct violations, and provides other firms with an understanding of compliance issues. Following up on the latter point, FDA issued another draft proposal to require FDA to generate and share information with the public about the most common inspectional observations with objectionable conditions or practices that are made during FDA inspections and to post that information online on a regular basis. 

Related to how FDA should disclose inspection reports and the findings from these reports is how FDA should disclose Warning Letters, which are issued for violations that may lead to enforcement action if not promptly and adequately corrected. FDA currently posts Warning Letters on its website. If FDA can determine that a firm has fully corrected violations raised in its Warning Letter, it will issue an official “close-out” notice that also will be posted online. If requested by the recipient of a Warning Letter, FDA will allow the company or individual to post a response to the Warning Letter. FDA also issues untitled letters, which are used for violations that do not meet the regulatory significance of violations in a Warning Letter, meaning alerting a company to enforcement action if the violation is not corrected. 

 Individuals and consumer groups suggested that all FDA Warning Letters and untitled letters be disclosed. The rationale was that the public should know  what firms FDA determined to be in violation and the agency’s reasoning for citing the violations. In considering these suggestions, FDA said such information is helpful for the public at large and helps to improve accountability among companies. The agency, however, raised concerns over the volume of this information, particularly the value of disclosing all untitled letters, which may be sent for relatively minor violations. 

 After considering these matters, FDA issued a draft proposal to require that the agency post untitled letters on the FDA website, and if requested by the recipient of the letter, a firm’s or individual’s response. In issuing the proposal, FDA concluded that public disclosure is helpful for the public at large and in overall compliance efforts. 

The FDA task force has given the public until July 20, 2010, to respond to these draft proposals and the other ones cited in its report. In soliciting these comments, FDA is also asking the public to consider which proposals should be given priority and the tools, techniques, and processes that the agency can use to improve transparency and efficiency while reducing costs. Based on this input, the task force will make specific proposals to the commissioner of FDA. 

 As a final phase, during this summer,  FDA will consider comments relating its transparency initiative to regulated industries. FDA had issued a notice and received comments in April 2010 on ways in which FDA could improve transparency to regulated industry and foster a more efficient and cost-effective process. Similar to how it evaluated comments from the public in making the draft proposals last month, the agency will consider the input from industry when making further draft proposals. The agency will solicit further comment on all draft proposals. 

Manufacturing

FDA issues draft proposals on ways to improve its disclosure on information relating to import procedures, inspections, and Warning Letters.

FDA Considers Ways to Improve Transparency in the Supply Chain

Bridging functional areas and skill sets to achieve a goal is crucial in business and scientific endeavors and is an equally important task when trying to realize larger societal goals. The American Association for the Advancement of Science (AAAS), through its Science and Human Rights Program, is seeking to do just that by engaging scientific and human rights groups to realize human rights generally, and the human right to scientific progress specifically. The association has launched several initiatives to facilitate ways in which the scientific community can become more involved with human rights and how science can be used as a tool in realizing human rights.  

The AAAS is a multidisciplinary scientific organization with direct membership of 130,000 individuals and affiliation of 262 scientific associations, which together serve more than 10 million scientists. The AAAS has had a Science and Human Rights Program since 1977. It has worked to bring scientific tools and techniques to promote and protect human rights in areas such as forensic science in the exhumation of mass graves and statistics to illuminate large-scale human rights violations. But the association is working to broaden the scope of its efforts. “Part of the mission of the program is to engage individual scientists and scientific associations in human rights efforts,” explains Jessica Wyndham, project director of the Science and Human Rights Program at AAAS. “This involves applying scientific tools and technologies to enhance human rights work, bringing human rights standards to the conduct of science, and promoting the human right to the benefit of science.” 

To realize those objectives, in 2005, the Science and Human Rights Program held a conference attended by scientific, academic, and human rights organizations, to explore ways in which the scientific community could become more directly engaged in human rights. Forty-two representatives of many of the largest scientific organizations in the United States, including the American Chemical Society, the American Statistical Association, and the American Public Health Association, took part in the conference. At the conference, the participants agreed to form a Science and Human Rights Coalition as part of the Science and Human Rights Program of the AAAS. After a two-year planning effort involving 20 scientific organizations, which began in 2007, the coalition was launched in January 2009. The coalition now includes 46 member and associated organizations and 51 individual scientists. It is organized into five working groups: welfare of scientists; science ethics and human rights; service to the scientific community; service to the human rights community; and education and information resources. 

A major underpinning of the work of the Science and Human Rights Coalition and the Science and Human Rights Program is to realize the human right to enjoy the benefits of scientific progress and its applications, a right that is articulated in the 

 was adopted by members of the United Nations General Assembly in 1948 and was the first comprehensive international instrument on human rights. “The links between science and human rights as expressed in the 

 are multiple,” explains Wyndham. She outlines several interrelationships:  

Several human rights require access to the benefits of science and technology in order to be realized, including the rights to information and freedom of expression, the rights to health and education, and the right to an adequate standard of living

	As shown by the Science and Human Rights Program, scientific tools, techniques, and methodologies are often valuable, if not vital, in identifying and showing the existence and extent of human rights violations, measuring progress toward the realization of human rights, and in bringing governments to account for their voluntarily assumed legal human rights obligations

Human rights standards are relevant to the conduct of scientific research

Although not well known to many in the scientific and human rights communities, the right to benefit from science is explicitly recognized in Article 27 of the 

which, states that “[e]veryone has the right to … share in scientific advancement and its benefits.”

 is not legally binding, but served as a basis for the development of two subsequent treaties in 1966, one of which was the 

International Covenant on Economic, Social and Cultural Rights,

 which has been adopted by 160 countries. Article 15 of that treaty obligates signatory governments to observe four key aspects relating to human rights and science. These include: recognizing the right of everyone to enjoy the benefits of scientific progress and its applications; conserving, developing, and diffusing science; respecting the freedom indispensable to scientific research; and recognizing the benefits of international contacts and cooperation in the scientific field. 

“Unlike the rights to freedom of expression or freedom from torture, for example, this human right provision is little known, and its significance and practical implications are yet to be explored,” says Wyndham. In recognition of the relevance of the human right to enjoy the benefits of scientific progress, in 2007, the AAAS Science and Human Rights Program  adopted Article 15 as the focus of one of its four programs areas and started working to engage scientific groups in clarifying the meaning of the right and promoting its implementation. “Program staff have conducted multiple trainings for AAAS staff and members of AAAS, its affiliates, and individual scientists,” she says. “We have developed a clearinghouse on information about the right, including literature, government reports on the implementation of the right, and exemplars of government actions that contribute to the realization of the right.”

Coincident to, but separate from the efforts of the AAAS, the United Nations  Educational, Scientific, and Cultural Organization (UNESCO), a specialized UN agency, initiated a process to elucidate the meaning of the human right to enjoy the benefits of science. “I was the only participant of a scientific organization invited to participate in the process,” says Wyndham, which reflected both the need and opportunity for mutual engagement by the human rights and scientific communities. The UNESCO process culminated in the adoption of the 

in July 2009, which outlines minimum core elements of the right and conceptual and practical challenges. These challenges, explains Wyndham, include the potential tension between an intellectual property estate and the right to access scientific benefits, particularly by marginalized and vulnerable communities. The 

also identifies the next steps toward giving the meaning to the right, including the need to raise awareness within the scientific community and the value of engaging scientists in clarifying the meaning and practical applications of the right.

Building on the process started by UNESCO and the recommendations of the 

in April 2010, the board of directors of AAAS adopted a statement on the human right to the benefits of scientific progress. “The purpose of the statement is to encourage greater and more effective engagement of the scientific community in the process of clarifying the meaning of this right and to outline the role to be played by AAAS in encouraging and facilitating such involvement,” explains Wyndham. “A principal way in which AAAS will take a leadership role in engaging the scientific community on this issue is through the Science and Human Rights Coalition.”

The Science and Human Rights Coalition is one of four ongoing initiatives of the AAAS Science and Human Rights Program.  The other three are: On-call Scientists, which connects scientists interested in volunteering their expertise to human rights organizations; the Geospatial Technologies and Human Rights Project, which uses satellite imagery and related technologies to document human rights violations that involve physical destruction (e.g., dwellings, villages, infrastructure) or the displacement of people; and the Article 15 Project, which aims to place the realization of the “right to enjoy the benefits of scientific progress”  on the agenda of the scientific community and to assist governments to realize the right in practice. 

Wyndham details the progress made by the working groups in the Science and Human Rights Coalition. The coalition developed a starter kit that scientific associations can use to evaluate how they can address human rights through their organizations. The coalition is starting to build the informational infrastructure required to work across disciplines, to incorporate human rights in science curricula, and to encourage collaborative partnerships between scientists and human rights organizations. Another key goal is to increase representation from the life, physical, and engineering sciences, which are currently underrepresented in the coalition, explains Wyndham. 

She also points to the interrelationship between the pharmaceutical industry and human rights. “The work of the pharmaceutical industry can have a significant impact on human rights,” she says. “From determining the target of research, the process by which a product is developed, and who has access to the product, human rights principles apply.” She points to several positive developments within the pharmaceutical industry that espouse the tenets of human rights and opportunities for their further realization such as programs that address the problem of neglected diseases, standards for the conduct of clinical-trials, and global health initiatives to increase access to medicines, particularly among marginalized and impoverished people. “In the context of our work on the right to the benefits of scientific progress, we expect to address these issues and welcome constructive and innovative ideas.” 

To that end, the AAAS Science and Human Rights Coalition  will meet July 26–27, 2010 in Washington DC. As part of that meeting, the Coalition Council will consider the adoption of a plan of action that sets out the coalition’s activities for engaging the scientific community in defining and promoting the right to the benefits of scientific progress. “In addition, we are developing a strategy to build bridges with the human rights community to identify ways in which scientists can contribute their work,” explains Wyndham. “And we are starting to tackle conceptually challenging questions, including the relationship between human rights and ethical standards.” 

Information about the Science and Human Rights Program at the AAAS can be found 

The American Association for the Advancement of Science rolls out several initiatives to increase partnerships and communication on human rights between scientific groups and between scientific and human rights groups.

AAAS Marries Science and Human Rights

Staff reductions, cost-cutting and doing more with less is today's reality for biopharmaceutical companies. A recently released analysis by BioPlan Associates, the 

7th Annual Report and Survey of Biopharmaceutical Manufacturing

, which gained the input of 327 biomanufacturers globally, examined the impact on biopharmaceutical manufacturers' internal operations and outsourcing activities (1).    

The survey examined 13 areas of operational changes affecting biomanufacturing. Biomanufacturers ranked productivity, cost-cutting, employee performance, and production quality as areas receiving their greatest focus (see Figure 1). Seventy-three of survey respondents said they are focusing on productivity to a "much greater" or "somewhat greater" extent compared with only 46% of respondents that say they are focusing on production quality to a greater extent (see Figure 1). 

The focus on productivity and performance is further shown in the study's budget data. Overall budgets in 2010 compared with those of  2009 are increasing, although budgets for outsourcing in operations are down slightly (–1.2%). Budgets are increasing in areas involving productivity. For example, 2010 budgets are favoring staffing for  internal process optimization and new technology investments. Budget data show that new hiring for operations and scientific staff is down slightly this year, but hiring for operational training to improve efficiency is up (+ 3.7%) from last year. 

The study shows a focus on improving process efficiencies through retraining and hiring for value-added activities rather than just for short-term cost savings. Process-development budgets are up nearly 3% in 2010, and the largest growth is in technologies to improve downstream operations, which is also one of the few areas in which hiring is increasing in 2010. 

This trend was  expressed in comments made by Paul Mehelic, principal scientist and group leader of global biologics at Pfizer (New York), who spoke at an IBC conference on biopharmaceutical manufacturing in Carlsbad, California, in early March. He noted that Pfizer's outsourcing approach involves determining "what strategically we can outsource [to] reduce costs, optimize speed, increase flexibility of our internal operations...redeploy internal FTEs [full-time equivalents] on more challenging and more value-added activities."  

Large companies have a breadth of resources and needs and therefore can sometimes more easily revise their internal resource strategies and capacity models. Mark O'Neill, director of business development of contract manufacturing at Amgen (Thousand Oaks, CA) said in an interview with BioPlan Associates that biopharmaceutical companies are working hard to balance their resources and costs, which includes excess capacity in their manufacturing networks. "Viable manufacturing options exist outside [an organization's] own network and are opening the door to considering mixed-capacity models where a company can use internal network capacity for both captive programs and external programs if the arrangement makes sense," he said.  

The biopharmaceutical industry's outsourcing segment is not all that old compared with small-molecule contract manufacturing and other areas for pharmaceutical outsourcing such as testing and product characterization. The current financial situation, however, has caused many to do some soul searching. Some contract manufacturing organizations (CMOs) are experiencing greater competitive and operational pressures due to the general industry slump. Other CMOs, such as Xcellerex (Marlborough, MA), have emphasized their enabling disposables technologies as part of their business model. This focus has had the effect of moving their business model away from a services-oriented one to more of a technology/device model.  

As the industry focuses more intensely on productivity and performance, many biologics CMOs are changing from a full-project approach to a milestone-oriented approach in the way they are structuring their proposals. Dan Leone, vice-president of business development at the biologics CMO Laureate Pharma (Princeton, NJ) observed that the industry's recent financial problems will ultimately benefit the more flexible and efficient CMOs. "Biopharmaceutical companies are managing their risks more carefully today," he said in an interview with BioPlan Associates. "They fund projects in stages and make project go–no–go decisions at specific milestones. This results in less exposure and risk for our clients. But to CMOs, this means doing step-wise work rather than full-project contracts." He says this approach requires CMOs to continually demonstrate reliability and value and prove themselves at each milestone before being awarded the next step. "This is good for the industry, and good for us, competitively," he said.   

Many biomanufacturers are still in a state of transition as they define their core capabilities. As this occurs, companies will outsource more low-value activities and move away from what they don't do efficiently. Companies will establish alliances and form relationships to complement their capabilities. The focus will be on productivity and getting more out of existing internal resources and maximizing performance from their provider relationships. A recent analysis by the Tufts Center for the Study of Drug Development showed that transactional relationships, which are about cutting costs, will be replaced by alliances. This change will likely be more expensive initially, but in the long term, such alliances will reduce redundancy, improve efficiency increase reliability, and become  more common in biomanufacturing outsourcing.  

 is president of BioPlan Associates, tel. 301.921.5979, 

th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

Impact of Outsourcing on Drug Development Performance and Economics,

 Tufts Center for Study of Drug Development (Boston, Sept. 2009).  

Outsourcing

Restructuring in the biopharmaceutical industry is renewing a focus on resource optimization.

Waste Not, Want Not

(Abbott Park, IL) released its 2009 Global Citizenship Report in early May. The report may be found 

(Baton Rouge), a specialty and fine-chemical producer, received awards from the American Chemistry Council (ACC) for the company’s contributions relating to environmental, safety, and health (EHS) activities. ACC is a US-based trade association representing chemical manufacturers. The company received: The Responsible Care Performance Award, which recognizes a company’s product stewardship efforts; the Responsible Care Facility Safety Certificate, for achievement in employee health and safety performance; and the Responsible Care Significant Improvement in Manufacturing for energy conservation at its facilities in South Haven, Michigan, and Bayport and Pasadena, Texas. Responsible Care is an EHS program for ACC member companies. 

Uwe E. Reinhardt, PhD, and the James Madison Professor of Political Economy and professor of economics at Princeton University, was named the 2010 recipient of the William B. Graham Prize for Health Services Research. The prize is funded by the 

Association of University Programs in Health Administration

 (New York) received Leadership in Energy and Environmental Design (LEED) silver certification for its biologics manufacturing facility in Devens, Massachusetts. LEED certification, established by the US Green Building Council and verified by the Green Building Certification Institute, is a program for the design, construction, and operation of high-performance green buildings. The company’s laboratory and office building at the Devens site received LEED gold certification in December 2009.  

, a philanthropic organization focused on fighting HIV/AIDS, announced the awarding of major grants to 35-community-based organizations to help improve access to care for people living with HIV/AIDS in five US areas: Chicago, New York, Oakland/San Francisco, North Carolina, and Louisiana. The grants were made possible through a separate grant by

 (Indianapolis, IN) reported on its progress in meeting its five-year environmental goals, which were announced last year. Its goals are to improve the energy efficiency of its operations and reduce corresponding greenhouse gases by 15%, reduce the amount of waste sent to landfills by 40%, and reduce water intake by 25%. Thus far, the company has increased energy efficiency by 5%, reduced greenhouse gases emissions by 5%, reduced the level of waste sent to landfills by 56%, and reduced water intake by 30%.  

 launched a six-year national vaccination program for Merck’s Gardasil (human papillomavirus quadrivalent (Types 6, 11, 16, and 18) vaccine for girls and young women between the ages of 12 and 18 in Bhutan. 

In a separate development, Merck & Co. received a 2010 Energy Star Sustained Excellence Award from the 

 in recognition of the company’s efforts to protect the environment through energy efficiency. 

 launched two new eLearning tools, one for ethics decision-making skills and another on how to address ethical dilemmas, at a meeting at the 

International Organization for Standardization

 (ISO) in Copenhagen in May. The tools were developed in partnership with Novo Nordisk, the University of Copenhagen, 

the United Nations Educational, Scientific and Cultural Organization, LRN,

 two management and services firms specializing in CSR implementation. 

 will collaborate to improve the healthcare infrastructure, specifically the supply chain, in developing countries beginning with Africa. The public–private collaboration will focus on the enhanced use of information and communication technologies to improve healthcare delivery. The effort is part of the World Bank’s eTransform Initiative, which was launched this spring.

 a nonprofit organization focused on discovering, developing, and delivering malaria treatments, formed an agreement for the development, access, and delivery of a fixed-dose combination treatment of azithromycin dihydrate and chloroquine phosphate for the treament of malaria in pregnant women. Pfizer will seek marketing authorization in select malaria-endemic African countries.

 a project standing for Education for Cancer in African Regions. Roche will work with the 

 to provide support in helping to combat cancer in sub-Saharan Africa. 

 (Paris) was awarded the 2010 Global Business Coalition Core Competence Award for its Malaria Access to Medicines partnership program with the 

 a nonprofit product-development partnership focused on research and development of new and improved treatments for neglected diseases.

In a separate development, sanofi-aventis announced the creation of the 

 which will focus on implementing health and solidarity programs worldwide. The foundation will be chaired by Jean-François Dehecq, honorary chairman of the company. 

 a standards-setting organization, plans to develop what it calls the first global organization-wide sustainability standard. The standard will define core sustainability principles for businesses and organizations based on metrics verified by a third party. The new standard will serve as a procurement tool and will aid in understanding a company’s sustainability performance profile.

A roundup of developments on corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other organizations.

PTSM: Pharmaceutical Technology Sourcing and Management-06-09-2010

The Pharmaceutical Industry Comes to the Aid of Haiti

FDA Considers Ways to Improve Transparency in the Supply Chain

AAAS Marries Science and Human Rights

Waste Not, Want Not

CSR and Sustainability Roundup